Respiratory Syncytial Virus InfectionsPhase 1/2NCT03814590

A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults

A Phase 1/2 study testing RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E and RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 21 sites in 2 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

The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E and RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,053 participants
Where: 21 sitesin 2 countries
Study dates: 21 Jan 2019to 30 Nov 2020
Phase: Phase 1/2
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For all subjects:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performing any study specific procedure.
For Part A:
A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
For Part B:
A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living.

Who cannot join

For all subjects:
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make IM injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.

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Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
Any other condition (e.g. chronic obstructive pulmonary disease or severe respiratory condition) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Previous vaccination with an RSV vaccine.
Lymphoproliferative disorder and malignancy within 5 years.
Body mass index > 40 kg/m².
Planned move to a location that will prohibit participating in the trial until study end.
At screening: Hematology parameters (complete blood cell count [red blood cells, white blood cells], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [alanine aminotransferase or aspartate aminotransferase]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
For Part A:
Pregnant or lactating female.
Female subjects of childbearing potential, except if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
For Part B:
Known previous administration of a vaccine containing MPL, QS-21 and/or MF59 (e.g. GSK Biologicals' vaccine against human papillomavirus infection marketed as Cervarix, GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix, an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su], or MF59 adjuvanted influenza vaccines [e.g. Fluad]).
Planned administration of GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine.
Bedridden subjects.

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States18 sites

GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Hickory, North Carolina, 28602
GSK Investigational Site
Houston, Texas, 77081
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Kansas City, Missouri, 64114
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Wichita, Kansas, 67207
GSK Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Belgium3 sites

GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years

As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, RSV Vaccine (GSK3844766A) unadjuvanted medium dose, RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Keywords: Respiratory syncytial virus (RSV), Vaccine, Safety, Reactogenicity, Immunogenicity
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.

RSV Vaccine (GSK3844766A) unadjuvanted low doseBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01EBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01BBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) unadjuvanted medium doseBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01EBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01BBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) unadjuvanted high doseBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01EBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01BBiological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Placebo (Saline solution)Drug
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.

Study groups in NCT03814590
Study group	Role	What they receive
Group Low Dose_PLAIN_A	Experimental	Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted low dose
Group Medium Dose_PLAIN_A	Experimental	Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Group High Dose_PLAIN_A	Experimental	Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose
Group Placebo_A	Placebo comparator	Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Drug: Placebo (Saline solution)
Group Low Dose_PLAIN_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted low dose
Group Low Dose_AS01E_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
Group Low Dose_AS01B_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
Group Medium Dose_PLAIN_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Group Medium Dose_AS01E_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Group Medium Dose_AS01B_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
Group High Dose_PLAIN_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose
Group High Dose_AS01E_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
Group High Dose_AS01B_B	Experimental	Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B
Group Placebo_B	Placebo comparator	Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. Receives: Drug: Placebo (Saline solution)

What is being measured

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

Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
Measured: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
Measured: During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Number of Subjects With Any Solicited General Symptom After First Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
Measured: During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
Measured: During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Measured: At baseline and at 7 days after the first vaccine dose (Day 8)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Measured: At baseline and at 7 days after the first vaccine dose (Day 8)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Measured: At baseline and at 7 days after the second vaccine dose (Day 68)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Measured: At baseline and at 7 days after the second vaccine dose (Day 68)
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
Measured: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first dose of vaccination
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
Measured: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second dose of vaccination
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second 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.
Measured: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination (Part B Groups)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)

Secondary outcomes (6)

Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups
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.
Measured: From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects Reporting pIMDs up to the End of Follow-up Period (Month 14) - Part B Groups
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups
The number of subjects with at least one RTI case was provided by group. Reported categories are RSV+ (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab) and RSV- (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab).
Measured: During the RSV season (from October 2019 to March 2020)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV-serotype A
Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
Measured: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).
Measured: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Descriptive Statistics of the Frequency of RSVPreF3 Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers
Among markers expressed were interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Reported statistics at each time point during which blood sample were collected for cell-mediated immunity, are geometric mean and inter-quartile range.
Measured: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

Timeline

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

21 Jan 201930 Nov 2020

First posted24 Jan 2019
Study start21 Jan 2019
Primary completion12 Dec 2019
Study completion30 Nov 2020

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,053 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03814590
Sponsor's protocol ID: 208851
Other IDs: 2018-000849-38, 2018
Status last verified: Jul 2022
First submitted: 11 Jan 2019
Last updated: 5 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Leroux-Roels I, Davis MG, Steenackers K, Essink B, Vandermeulen C, Fogarty C, Andrews CP, Kerwin E, David MP, Fissette L, Vanden Abeele C, Collete D, de Heusch M, Salaun B, De Schrevel N, Koch J, Verheust C, Dezutter N, Struyf F, Mesaros N, Tica J, Hulstrom V. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. J Infect Dis. 2023 Mar 28;227(6):761-772. doi: 10.1093/infdis/jiac327.
PubMed 35904987

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years
ClinicalTrials.gov ID: NCT03814590
Acronym / sponsor ID: 208851
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus (RSV), Vaccine, Safety, Reactogenicity, Immunogenicity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,053 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Jan 2019 (actual)
Primary completion: 12 Dec 2019 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 24 Jan 2019 (actual)
Results: Posted 23 Mar 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 14

Arm	Type	Receives
Group Low Dose_PLAIN_A	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted low doseSubjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_PLAIN_A	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium doseSubjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_PLAIN_A	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted high doseSubjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Placebo_A	Placebo comparator	Drug: Placebo (Saline solution)Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_PLAIN_B	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted low doseSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_AS01E_B	Experimental	Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01ESubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_AS01B_B	Experimental	Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01BSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_PLAIN_B	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium doseSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_AS01E_B	Experimental	Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01ESubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_AS01B_B	Experimental	Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01BSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_PLAIN_B	Experimental	Biological: RSV Vaccine (GSK3844766A) unadjuvanted high doseSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_AS01E_B	Experimental	Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01ESubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_AS01B_B	Experimental	Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01BSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Placebo_B	Placebo comparator	Drug: Placebo (Saline solution)Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performing any study specific procedure.
A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living.

Key exclusion criteria (34 listed)

Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make IM injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.

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
RSV Vaccine (GSK3844766A) unadjuvanted low doseTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm	Biological	Group Low Dose_PLAIN_A, Group Low Dose_PLAIN_B
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01ETwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group Low Dose_AS01E_B
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01BTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm	Biological	Group Low Dose_AS01B_B
RSV Vaccine (GSK3844766A) unadjuvanted medium doseTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group Medium Dose_PLAIN_A, Group Medium Dose_PLAIN_B
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01ETwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group Medium Dose_AS01E_B
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01BTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group Medium Dose_AS01B_B
RSV Vaccine (GSK3844766A) unadjuvanted high doseTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group High Dose_PLAIN_A, Group High Dose_PLAIN_B
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01ETwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm	Biological	Group High Dose_AS01E_B
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01BTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Biological	Group High Dose_AS01B_B
Placebo (Saline solution)Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.	Drug	Group Placebo_A, Group Placebo_B

Primary outcome

Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose
Time frame: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose
Time frame: During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
Number of Subjects With Any Solicited General Symptom After First Vaccination Dose
Time frame: During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose
Time frame: During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose
Time frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)
Time frame: At baseline and at 7 days after the first vaccine dose (Day 8)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups)
Time frame: At baseline and at 7 days after the first vaccine dose (Day 8)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups)
Time frame: At baseline and at 7 days after the second vaccine dose (Day 68)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups)
Time frame: At baseline and at 7 days after the second vaccine dose (Day 68)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
Time frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first dose of vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
Time frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second dose of vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
Time frame: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
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.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination (Part B Groups)
Time frame: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

6 secondary outcomes

Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups
Time frame: From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects Reporting pIMDs up to the End of Follow-up Period (Month 14) - Part B Groups
Time frame: From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups
Time frame: During the RSV season (from October 2019 to March 2020)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV-serotype A
Time frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
Time frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Descriptive Statistics of the Frequency of RSVPreF3 Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers
Time frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

Results and safety

Results posted to the registry on 23 Mar 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
Low Dose_PLAIN_A Group	12	12
Medium Dose_PLAIN_A Group	12	10
High Dose_PLAIN_A Group	12	11
Placebo_A Group	12	12
Low Dose_PLAIN_B Group	101	100
Medium Dose_PLAIN_B Group	97	92
High Dose_PLAIN_B Group	100	97
Low Dose_AS01E_B Group	101	95
Medium Dose_AS01E_B Group	101	101
High Dose_AS01E_B Group	100	95
Low Dose_AS01B_B Group	103	100
Medium Dose_AS01B_B Group	100	100
High Dose_AS01B_B Group	101	97
Placebo_B Group	101	98

Primary outcome: Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose

Time frame: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days). Count of participants. Unit: Participants

Measure	Low Dose_PLAIN_A Group n = 12	Medium Dose_PLAIN_A Group n = 12	High Dose_PLAIN_A Group n = 11	Low Dose_PLAIN_B Group n = 100	Medium Dose_PLAIN_B Group n = 96	High Dose_PLAIN_B Group n = 99	Low Dose_AS01E_B Group n = 101	Medium Dose_AS01E_B Group n = 100	High Dose_AS01E_B Group n = 100	Low Dose_AS01B_B Group n = 103	Medium Dose_AS01B_B Group n = 99	High Dose_AS01B_B Group n = 101	Placebo_B Group n = 98
Erythema	0	1	0	0	1	2	5	6	9	16	15	18	1
Pain	1	7	6	9	5	14	54	57	56	78	63	76	4
Swelling	0	0	0	0	0	2	7	7	6	10	7	9	0

Population analysed: The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented and with the subject diary completed after the first vaccination.

Primary outcome: Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose

Time frame: During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days). Count of participants. Unit: Participants

Measure	Low Dose_PLAIN_A Group n = 12	Medium Dose_PLAIN_A Group n = 10	High Dose_PLAIN_A Group n = 11	Placebo_A Group n = 12	Low Dose_PLAIN_B Group n = 95	Medium Dose_PLAIN_B Group n = 91	High Dose_PLAIN_B Group n = 90	Low Dose_AS01E_B Group n = 94	Medium Dose_AS01E_B Group n = 94	High Dose_AS01E_B Group n = 95	Low Dose_AS01B_B Group n = 96	Medium Dose_AS01B_B Group n = 93	High Dose_AS01B_B Group n = 93	Placebo_B Group n = 97
Erythema	0	0	0	0	1	0	2	3	3	7	16	14	12	0
Pain	5	7	8	1	18	18	23	34	48	47	58	56	59	4
Swelling	0	0	0	0	0	1	2	3	3	6	10	7	10	0

Primary outcome: Number of Subjects With Any Solicited General Symptom After First Vaccination Dose

Time frame: During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days). Count of participants. Unit: Participants

Measure	Low Dose_PLAIN_A Group n = 12	Medium Dose_PLAIN_A Group n = 12	High Dose_PLAIN_A Group n = 11	Placebo_A Group n = 12	Low Dose_PLAIN_B Group n = 100	Medium Dose_PLAIN_B Group n = 96	High Dose_PLAIN_B Group n = 99	Low Dose_AS01E_B Group n = 101	Medium Dose_AS01E_B Group n = 100	High Dose_AS01E_B Group n = 100	Low Dose_AS01B_B Group n = 103	Medium Dose_AS01B_B Group n = 99	High Dose_AS01B_B Group n = 101	Placebo_B Group n = 98
Arthralgia	0	0	0	0	7	4	0	7	12	6	15	9	17	7
Fatigue	4	5	1	6	22	11	24	26	28	21	30	29	49	16
Fever	0	0	0	0	1	0	0	1	3	1	3	3	1	0
Gastrointestinal symptoms	1	2	1	1	8	8	10	8	8	9	13	7	13	10
Headache	2	4	3	2	8

Primary outcome: Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose

Time frame: During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days). Count of participants. Unit: Participants

Measure	Low Dose_PLAIN_A Group n = 12	Medium Dose_PLAIN_A Group n = 10	High Dose_PLAIN_A Group n = 11	Placebo_A Group n = 12	Low Dose_PLAIN_B Group n = 95	Medium Dose_PLAIN_B Group n = 91	High Dose_PLAIN_B Group n = 90	Low Dose_AS01E_B Group n = 94	Medium Dose_AS01E_B Group n = 94	High Dose_AS01E_B Group n = 95	Low Dose_AS01B_B Group n = 96	Medium Dose_AS01B_B Group n = 93	High Dose_AS01B_B Group n = 93	Placebo_B Group n = 97
Arthralgia	0	0	0	0	1	4	2	8	8	10	21	11	13	4
Fatigue	3	2	4	5	16	11	13	24	22	24	35	35	34	16
Fever	0	0	0	0	0	0	0	3	1	1	4	6	3	0
Gastrointestinal symptoms	1	1	2	2	4	2	7	7	5	7	11	7	9	6
Headache	2	2	3	3	11

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Day 91 for Part A groups and till Month 14 for Part B groups.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose_PLAIN_A Group	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Medium Dose_PLAIN_A Group	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
High Dose_PLAIN_A Group	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Placebo_A Group	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Low Dose_PLAIN_B Group	13 of 101 (12.9%)	62 of 101 (61.4%)	0 of 101
Medium Dose_PLAIN_B Group	3 of 97 (3.1%)	54 of 97 (55.7%)	1 of 97
High Dose_PLAIN_B Group	5 of 100 (5%)	61 of 100 (61%)	1 of 100
Low Dose_AS01E_B Group	8 of 101 (7.9%)	77 of 101 (76.2%)	0 of 101
Medium Dose_AS01E_B Group	6 of 101 (5.9%)	80 of 101 (79.2%)	0 of 101
High Dose_AS01E_B Group	11 of 100 (11%)	83 of 100 (83%)	0 of 100
Low Dose_AS01B_B Group	9 of 103 (8.7%)	91 of 103 (88.3%)	1 of 103
Medium Dose_AS01B_B Group	5 of 100 (5%)	88 of 100 (88%)	0 of 100
High Dose_AS01B_B Group	9 of 101 (8.9%)	93 of 101 (92.1%)	1 of 101
Placebo_B Group	9 of 101 (8.9%)	54 of 101 (53.5%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35904987Leroux-Roels I, Davis MG, Steenackers K, Essink B, Vandermeulen C, Fogarty C, Andrews CP, Kerwin E, David MP, Fissette L, Vanden Abeele C, Collete D, de Heusch M, Salaun B, De Schrevel N, Koch J, Verheust C, Dezutter N, Struyf F, Mesaros N, Tica J, Hulstrom V. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. J Infect Dis. 2023 Mar 28;227(6):761-772. doi: 10.1093/infdis/jiac327.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 34 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Belgium. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Mar 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?

Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose (time frame: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)). The study lists 13 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 NCT03814590, 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 5 Aug 2022.