Respiratory Syncytial Virus InfectionsPhase 2NCT04138056

A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

A Phase 2 study testing RSVPreF3 formulation 3, RSVPreF3 formulation 2 and Boostrix-ex-US in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSVPreF3 formulation 3, RSVPreF3 formulation 2 and Boostrix-ex-US
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 509 participants
Where: 8 sitesin 3 countries
Study dates: 5 Nov 2019to 22 Nov 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Primary study
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure.
Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to primary vaccination, and

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has a negative pregnancy test on the day of primary vaccination, and
has agreed to continue adequate contraception for 90 days after completion of the vaccination.
No local condition precluding injection in both left and right deltoid muscles.
Extension study
Completed primary study and received 1st dose of a study vaccine.
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension.
All subjects must satisfy ALL the following criteria:
Subjects who can and will comply with the requirements of the protocol.
Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
Female subjects of childbearing potential are eligible for the extension, if the subject:
has practiced adequate contraception for 30 days prior to 2nd vaccination
has a negative pregnancy test with results available on the day of 2nd vaccination
has agreed to continue adequate contraception for 90 days after completion of the 2nd vaccination.

Who cannot join

Primary study
Medical conditions
History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
Hypersensitivity to latex;
Major congenital defects;

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Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
Significant/uncontrolled psychiatric illness;
Recurrent history/uncontrolled neurological disorders/seizures;
Documented HIV-positive subject;
History of/current autoimmune disease;
Body mass index (BMI)>40 kg/m^2;
Any clinically significant hematological parameter and/or biochemical laboratory abnormality.
Any other clinical condition that might pose additional risk to the subject due to participation in the study.
Prior/Concomitant therapy
Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before 1st vaccination, or planned use during the study;
Administration of long-acting immune-modifying drugs at any time during the study;
Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st vaccination or planned administration during the study;
Chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to 1st vaccine dose(s). For corticosteroids, this will mean prednisone ≥5 mg/day, or equivalent. Inhaled and topical steroids are allowed;
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 1st vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination;
Administration of a vaccine containing diphtheria, tetanus/pertussis antigens/diphtheria and tetanus toxoids within the previous 5 years;
Previous experimental vaccination against RSV;
Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;
Other exclusions
Pregnant/lactating female;
Female planning to become pregnant/planning to discontinue contraceptive precautions;
History of alcoholism, drug abuse and/or use disorder within the past 2 years;
Any study personnel/their immediate dependents, family/household members.
Extension study
Medical conditions
History of any reaction/hypersensitivity likely to be exacerbated by any component of the vaccines;
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
Hypersensitivity to latex;
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
Significant/uncontrolled psychiatric illness;
Recurrent history/uncontrolled neurological disorders/seizures;
Documented HIV-positive subject;
History of/current autoimmune disease;
BMI>40 kg/m^2;
Participants who experienced any SAE judged to be possibly or probably related to 1st dose of RSVPreF3, including hypersensitivity reactions.
Any other clinical condition that might pose additional risk to the subject due to participation in the study.
Prior/Concomitant therapy
Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before the 2nd vaccination, or planned use during the 6-month study extension;
Administration of long-acting immune-modifying drugs at any time during the study;
Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st dose of study vaccines/planned administration during the study;
Chronic administration of immunosuppressants or other immune-modifying drugs during the starting 3 months prior to the 1st vaccine dose(s). For corticosteroids, this will mean prednisone ≥5 mg/day, or equivalent. Inhaled and topical steroids are allowed;
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 2nd vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination.
Prior/Concurrent clinical study experience
Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;
Other exclusions
Pregnant/lactating female at the time of Visit 4;
Female planning to become pregnant/planning to discontinue contraceptive precautions;
History of alcoholism, drug abuse and/or use disorder within the past 2 years;
Any study personnel/their immediate dependents, family/household members.

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

United States4 sites

GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Seattle, Washington, 98105

Other trials in United States

Belgium2 sites

GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000

Other trials in Belgium

Canada2 sites

GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3 formulation 3, RSVPreF3 formulation 2, Boostrix-ex-US, Boostrix-US, Placebo
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSVPreF3 formulation 3Biological
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
RSVPreF3 formulation 2Biological
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Boostrix-ex-USBiological
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
Boostrix-USBiological
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
PlaceboDrug
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.

Study groups in NCT04138056
Study group	Role	What they receive
RSV120_dTpa_RSV120(Pooled)	Experimental	Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. Receives: Biological: RSVPreF3 formulation 3; Biological: Boostrix-ex-US; Biological: Boostrix-US
RSV120_Placebo_RSV120(Pooled)	Placebo comparator	Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. Receives: Biological: RSVPreF3 formulation 3; Drug: Placebo
RSV60_dTpa_RSV120(Pooled)	Experimental	Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. Receives: Biological: RSVPreF3 formulation 3; Biological: RSVPreF3 formulation 2; Biological: Boostrix-ex-US; Biological: Boostrix-US
RSV60_Placebo_RSV120(Pooled)	Placebo comparator	Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. Receives: Biological: RSVPreF3 formulation 3; Biological: RSVPreF3 formulation 2; Drug: Placebo
dTpa_Placebo_RSV120(Pooled)	Placebo comparator	Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end. Receives: Biological: RSVPreF3 formulation 3; Biological: Boostrix-ex-US; Biological: Boostrix-US; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs [Primary Study]
Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs [Primary Study]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From Day 1 to Day 31
Number of Subjects With Any SAEs [Primary Study]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From Day 1 to Day 31
Percentage of Subjects With Any Solicited Local AEs [Extension Study]
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects Any Solicited General AEs [Extension Period]
Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects With Any Unsolicited AEs [Extension Period]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
Number of Subjects With Any SAEs [Extension Period]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60).
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Screening (Day -7 to Day 1)
RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 8
RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 31
RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ).
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 8
RSV PreF3 IgG GMCs at Day 31 [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 31

Secondary outcomes (31)

Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.
Measured: From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]
Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.
Measured: From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.
Measured: From Day 1 to Day 31
Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.
Measured: From Day 1 to Day 31
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From Day 1 to Day 181
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.
Measured: From Day 1 to Day 181
Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Measured: From the Day of 2nd vaccination to Day 181 post 2nd vaccination
RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At Screening (Day -7 to Day 1)
RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At Day 8
RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At Day 31
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 31 post 2nd vaccination
RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.
Measured: At Day 8
RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.
Measured: At Day 31
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.
Measured: At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA.
The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
Measured: At Day 31 post 2nd vaccination
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Day 31
Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Day 31
Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.
The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).
Measured: At Day 31
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Day 31
Diphtheria (Anti-D) GMCs at Screening [Primary Study]
Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]
Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Day 31
Tetanus (Anti-T) GMCs at Screening [Primary Study]
Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 [Primary Study]
Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.
Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Measured: At Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201922 Nov 2021

First posted24 Oct 2019
Study start5 Nov 2019
Primary completion25 Feb 2020
Study completion22 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04138056
Sponsor's protocol ID: 209141
Other IDs: 2019-002258-22, 2019
Status last verified: Jul 2024
First submitted: 22 Oct 2019
Last updated: 21 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.
PubMed 38133639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine
ClinicalTrials.gov ID: NCT04138056
Acronym / sponsor ID: 209141
Conditions: Respiratory Syncytial Virus Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 509 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 Nov 2019 (actual)
Primary completion: 25 Feb 2020 (actual)
Study completion: 22 Nov 2021 (actual)
First posted: 24 Oct 2019 (actual)
Results: Posted 19 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
RSV120_dTpa_RSV120(Pooled)	Experimental	Biological: RSVPreF3 formulation 3, Biological: Boostrix-ex-US, Biological: Boostrix-USSubjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV120_Placebo_RSV120(Pooled)	Placebo comparator	Biological: RSVPreF3 formulation 3, Drug: PlaceboSubjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV60_dTpa_RSV120(Pooled)	Experimental	Biological: RSVPreF3 formulation 3, Biological: RSVPreF3 formulation 2, Biological: Boostrix-ex-US, Biological: Boostrix-USSubjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV60_Placebo_RSV120(Pooled)	Placebo comparator	Biological: RSVPreF3 formulation 3, Biological: RSVPreF3 formulation 2, Drug: PlaceboSubjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
dTpa_Placebo_RSV120(Pooled)	Placebo comparator	Biological: RSVPreF3 formulation 3, Biological: Boostrix-ex-US, Biological: Boostrix-US, Drug: PlaceboSubjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (19 listed)

Primary study
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure.
Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
Female subjects of childbearing potential may be enrolled in the study, if the subject:

Key exclusion criteria (54 listed)

Primary study
Medical conditions
History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
Hypersensitivity to latex;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSVPreF3 formulation 3One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.	Biological	RSV120_Placebo_RSV120(Pooled), RSV120_dTpa_RSV120(Pooled), RSV60_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), dTpa_Placebo_RSV120(Pooled)
RSVPreF3 formulation 2One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.	Biological	RSV60_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled)
Boostrix-ex-USOne dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.	Biological	RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), dTpa_Placebo_RSV120(Pooled)
Boostrix-USOne dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.	Biological	RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), dTpa_Placebo_RSV120(Pooled)
PlaceboOne dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.	Drug	RSV120_Placebo_RSV120(Pooled), RSV60_Placebo_RSV120(Pooled), dTpa_Placebo_RSV120(Pooled)

Primary outcome

Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]
Time frame: From Day 1 to Day 8
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Percentage of Subjects With Any Solicited General AEs [Primary Study]
Time frame: From Day 1 to Day 8
Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Percentage of Subjects With Any Unsolicited AEs [Primary Study]
Time frame: From Day 1 to Day 31
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Number of Subjects With Any SAEs [Primary Study]
Time frame: From Day 1 to Day 31
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Percentage of Subjects With Any Solicited Local AEs [Extension Study]
Time frame: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Percentage of Subjects Any Solicited General AEs [Extension Period]
Time frame: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Percentage of Subjects With Any Unsolicited AEs [Extension Period]
Time frame: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
Number of Subjects With Any SAEs [Extension Period]
Time frame: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.
RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]
Time frame: At Day 8
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]
Time frame: At Day 31
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
RSV PreF3 IgG GMCs at Day 8 [Primary Study]
Time frame: At Day 8
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.
RSV PreF3 IgG GMCs at Day 31 [Primary Study]
Time frame: At Day 31
Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

31 secondary outcomes

Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]
Time frame: From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]
Time frame: From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]
Time frame: From Day 1 to Day 31
Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]
Time frame: From Day 1 to Day 31
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]
Time frame: From Day 1 to Day 181
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]
Time frame: From Day 1 to Day 181
Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]
Time frame: From the Day of 2nd vaccination to Day 181 post 2nd vaccination
RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 8
RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 31
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]
Time frame: At Day 31 post 2nd vaccination
RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 8
RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 31
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]
Time frame: At Day 31 post 2nd vaccination
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 31
Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 31
Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
Time frame: At Day 31
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]
Time frame: At Day 31
Diphtheria (Anti-D) GMCs at Screening [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]
Time frame: At Day 31
Tetanus (Anti-T) GMCs at Screening [Primary Study]
Time frame: At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 [Primary Study]
Time frame: At Day 31

Results and safety

Results posted to the registry on 19 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RSV120_dTpa_RSV120(Pooled)	101	95
RSV120_Placebo_RSV120(Pooled)	101	93
RSV60_dTpa_RSV120(Pooled)	103	100
RSV60_Placebo_RSV120(Pooled)	102	100
dTpa_Placebo_RSV120(Pooled)	102	98

Primary outcome: Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]

Time frame: From Day 1 to Day 8. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV120_dTpa_RSV120(Pooled) n = 101	RSV120_Placebo_RSV120(Pooled) n = 100	RSV60_dTpa_RSV120(Pooled) n = 103	RSV60_Placebo_RSV120(Pooled) n = 102	dTpa_Placebo_RSV120(Pooled) n = 99
RSVPreF3 (Left Arm), Erythema	5.9 (2.2 to 12.5)	5 (1.6 to 11.3)	5.8 (2.2 to 12.2)	5.9 (2.2 to 12.4)	0 (0 to 3.7)
RSVPreF3 (Left Arm), Pain	51.5 (41.3 to 61.6)	54 (43.7 to 64)	52.4 (42.4 to 62.4)	58.8 (48.6 to 68.5)	19.2 (12 to 28.3)
RSVPreF3 (Left Arm), Swelling	2 (0.2 to 7)	7 (2.9 to 13.9)	2.9 (0.6 to 8.3)	4.9 (1.6 to 11.1)	0 (0 to 3.7)
dTpa (Right Arm), Erythema	4 (1.1 to 9.8)	1 (0 to 5.4)	4.9 (1.6 to 11)	1 (0 to 5.3)	6.1 (2.3 to 12.7)
dTpa (Right Arm), Pain	81.2 (72.2 to 88.3)	25 (16.9 to 34.7)	76.7 (67.3 to 84.5)	18.6 (11.6 to 27.6)	78.8 (69.4 to 86.4)
dTpa (Right Arm), Swelling	5 (1.6 to 11.2)	0 (0 to 3.6)	1.9 (0.2 to 6.8)	1 (0 to 5.3)	4 (1.1 to 10)

Population analysed: The analysis was performed on the Solicited Safety Set (SSS) - Primary Study which consisted of all subjects from the Exposed set (ES) - Primary Study for whom solicited safety data were available.

Primary outcome: Percentage of Subjects With Any Solicited General AEs [Primary Study]

Time frame: From Day 1 to Day 8. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV120_dTpa_RSV120(Pooled) n = 101	RSV120_Placebo_RSV120(Pooled) n = 101	RSV60_dTpa_RSV120(Pooled) n = 103	RSV60_Placebo_RSV120(Pooled) n = 102	dTpa_Placebo_RSV120(Pooled) n = 99
Fatigue	40.6 (30.9 to 50.8)	39.6 (30 to 49.8)	37.9 (28.5 to 48)	32.4 (23.4 to 42.3)	38.4 (28.8 to 48.7)
Gastrointestinal symptoms	23.8 (15.9 to 33.3)	28.7 (20.1 to 38.6)	27.2 (18.9 to 36.8)	28.4 (19.9 to 38.2)	28.3 (19.7 to 38.2)
Headache	44.6 (34.7 to 54.8)	45.5 (35.6 to 55.8)	35 (25.8 to 45)	39.2 (29.7 to 49.4)	37.4 (27.9 to 47.7)
Temperature	2 (0.2 to 7)	4 (1.1 to 9.8)	2.9 (0.6 to 8.3)	3.9 (1.1 to 9.7)	7.1 (2.9 to 14)

Population analysed: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.

Primary outcome: Percentage of Subjects With Any Unsolicited AEs [Primary Study]

Time frame: From Day 1 to Day 31. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV120_dTpa_RSV120(Pooled) n = 101	RSV120_Placebo_RSV120(Pooled) n = 101	RSV60_dTpa_RSV120(Pooled) n = 103	RSV60_Placebo_RSV120(Pooled) n = 102	dTpa_Placebo_RSV120(Pooled) n = 102
Value	38.6 (29.1 to 48.8)	34.7 (25.5 to 44.8)	33 (24.1 to 43)	37.3 (27.9 to 47.4)	32.4 (23.4 to 42.3)

Population analysed: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

Primary outcome: Number of Subjects With Any SAEs [Primary Study]

Time frame: From Day 1 to Day 31. Count of participants. Unit: Participants

Measure	RSV120_dTpa_RSV120(Pooled) n = 101	RSV120_Placebo_RSV120(Pooled) n = 101	RSV60_dTpa_RSV120(Pooled) n = 103	RSV60_Placebo_RSV120(Pooled) n = 102	dTpa_Placebo_RSV120(Pooled) n = 102
Value	0	0	0	0	0

Population analysed: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

31 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSV120_dTpa_RSV120(Pooled)	1 of 101 (1%)	92 of 101 (91.1%)	0 of 101
RSV120_Placebo_RSV120(Pooled)	0 of 101 (0%)	90 of 101 (89.1%)	0 of 101
RSV60_dTpa_RSV120(Pooled)	0 of 103 (0%)	91 of 103 (88.3%)	0 of 103
RSV60_Placebo_RSV120(Pooled)	1 of 102 (1%)	82 of 102 (80.4%)	0 of 102
dTpa_Placebo_RSV120(Pooled)	0 of 102 (0%)	89 of 102 (87.3%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38133639Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSVPreF3 formulation 3, RSVPreF3 formulation 2 and Boostrix-ex-US in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] (time frame: From Day 1 to Day 8). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04138056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.