Respiratory Syncytial Virus InfectionsPhase 3NCT05045144

A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

A Phase 3 study testing RSVPreF3(120 μg) and Flu Quadrivalent influenza vaccine (15 μg HA) in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 36 sites in 5 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 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSVPreF3(120 μg) and Flu Quadrivalent influenza vaccine (15 μg HA)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,586 participants
Where: 36 sitesin 5 countries
Study dates: 26 Oct 2021to 6 Jun 2022
Phase: Phase 3
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 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participants 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 participant prior to performance of any study specific procedure.
Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
Female participants of childbearing potential may be enrolled in the study, if the participant:
has practiced adequate contraception for 1 month prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration.
No local condition precluding injection in both left and right deltoid muscles.

Who cannot join

Medical conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination;
Hypersensitivity to latex;
Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study;

Show all 27Show fewer

Significant or uncontrolled psychiatric illness;
Recurrent history or uncontrolled neurological disorders or seizures;
Documented HIV-positive participant;
Body mass index > 40 kg/m^2;
Any clinically significant* hematological parameter and/or biochemical laboratory abnormality.
The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
Use of any investigational or non-registered product other than the study intervention(s) during the period starting 30 days before study intervention (Day -29 to Day 1), or planned use during the study period;
Administration of long-acting immune-modifying drugs at any time during the study period;
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration during the study period;
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention 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 the vaccination dose;
Administration of a seasonal influenza vaccine during the 6 months preceding entry into the study;
Previous experimental vaccination against RSV.
Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product;
Other exclusions
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive precautions;
Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving;
Any study personnel or their immediate dependents, family, or household members.

Trial locations and contacts

36 sites in 5 countries.

Country

City, postcode or hospital

36 sites in 5 countries

Canada11 sites

GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Mirabel, Quebec, J7J 2K8
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8
GSK Investigational Site
Surrey, British Columbia, V3S 2N6
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Vancouver, British Columbia, V6Z 2T1

Other trials in Canada

Finland9 sites

GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520

Other trials in Finland

Spain8 sites

GSK Investigational Site
Alcorcón/Madrid, 28922
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Valencia, 46015

Other trials in Spain

United States5 sites

GSK Investigational Site
Peoria, Illinois, 61614
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
Springfield, Missouri, 65802
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
West Palm Beach, Florida, 33409

Other trials in United States

South Korea3 sites

GSK Investigational Site
Gyeonggi-do, 15355
GSK Investigational Site
Seoul, 07441
GSK Investigational Site
Seoul, 08308

Other trials in South Korea

About this study

Official title: A Phase III, Randomized, Multi-country Study to Evaluate the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK's Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age.

The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA), Placebo
Keywords: Respiratory Syncytial Virus Maternal vaccine, Flu Quadrivalent influenza vaccine, Lot-to-lot consistency, Immunogenicity, Safety, Reactogenicity
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(120 μg)Combination product
A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
Flu Quadrivalent influenza vaccine (15 μg HA)Combination product
A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
PlaceboCombination product
One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.

Study groups in NCT05045144
Study group	Role	What they receive
RSV lot1 Group	Experimental	Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Receives: Combination Product: RSVPreF3(120 μg)
RSV lot2 Group	Experimental	Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Receives: Combination Product: RSVPreF3(120 μg)
RSV lot3 Group	Experimental	Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Receives: Combination Product: RSVPreF3(120 μg)
RSV+Flu pooled Group	Experimental	Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. Receives: Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA)
Flu+Placebo Group	Active comparator	Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. Receives: Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA); Combination Product: Placebo

What is being measured

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

Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: From Day 1 to Day 7 (including Day 7)
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: From Day 1 to Day 7 (including Day 7)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
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 reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: From Day 1 to Day 30 (including Day 30)
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: From Day 1 to Day 30 (including Day 30)
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: From first vaccination up to study end (Day 1 to Day 181)
RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.
Measured: At Day 31
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31
Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 31

Secondary outcomes (9)

RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 1 and Day 31
Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31
The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer <1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 31
RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 1 and Day 31
RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 1 and Day 31
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31
Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 1 and Day 31
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31
SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Measured: At Day 1 and Day 31
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.
Measured: At Day 1 and Day 31
RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.
Measured: At Day 1 and Day 31
RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots.
Measured: At Day 1 and Day 31

Timeline

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

26 Oct 20216 Jun 2022

First posted16 Sep 2021
Study start26 Oct 2021
Primary completion6 Jun 2022
Study completion6 Jun 2022

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,586 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05045144
Sponsor's protocol ID: 214709
Other IDs: 2021-000357-26
Status last verified: Sep 2023
First submitted: 6 Sep 2021
Last updated: 5 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342.
PubMed 38970327

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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A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
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RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
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All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Multi-country Study to Evaluate the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK's Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age.
ClinicalTrials.gov ID: NCT05045144
Acronym / sponsor ID: 214709
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus Maternal vaccine, Flu Quadrivalent influenza vaccine, Lot-to-lot consistency, Immunogenicity, Safety, Reactogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,586 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 26 Oct 2021 (actual)
Primary completion: 6 Jun 2022 (actual)
Study completion: 6 Jun 2022 (actual)
First posted: 16 Sep 2021 (actual)
Results: Posted 5 Oct 2023

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
RSV lot1 Group	Experimental	Combination Product: RSVPreF3(120 μg)Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSV lot2 Group	Experimental	Combination Product: RSVPreF3(120 μg)Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSV lot3 Group	Experimental	Combination Product: RSVPreF3(120 μg)Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSV+Flu pooled Group	Experimental	Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA)Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.
Flu+Placebo Group	Active comparator	Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA), Combination Product: PlaceboParticipants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Participants 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 participant prior to performance of any study specific procedure.
Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
No local condition precluding injection in both left and right deltoid muscles.

Key exclusion criteria (27 listed)

Medical conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination;
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(120 μg)A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.	Combination product	RSV lot1 Group, RSV lot2 Group, RSV lot3 Group
Flu Quadrivalent influenza vaccine (15 μg HA)A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).	Combination product	Flu+Placebo Group, RSV+Flu pooled Group
PlaceboOne dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.	Combination product	Flu+Placebo Group

Primary outcome

Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Time frame: From Day 1 to Day 7 (including Day 7)
Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Time frame: From Day 1 to Day 7 (including Day 7)
Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Time frame: From Day 1 to Day 30 (including Day 30)
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 reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Time frame: From Day 1 to Day 30 (including Day 30)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Time frame: From first vaccination up to study end (Day 1 to Day 181)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.
RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31
Time frame: At Day 31
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31
Time frame: At Day 31
Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

9 secondary outcomes

RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Time frame: At Day 1 and Day 31
Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31
Time frame: At Day 31
RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Time frame: At Day 1 and Day 31
RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
Time frame: At Day 1 and Day 31
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31
Time frame: At Day 1 and Day 31
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31
Time frame: At Day 1 and Day 31
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Time frame: At Day 1 and Day 31
RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Time frame: At Day 1 and Day 31
RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
Time frame: At Day 1 and Day 31

Results and safety

Results posted to the registry on 5 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RSV lot1 Group	220	217
RSV lot2 Group	223	220
RSV lot3 Group	218	214
RSV+Flu Pooled Group	438	433
Flu+Placebo Group	440	427

Primary outcome: Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Time frame: From Day 1 to Day 7 (including Day 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV Pooled Group n = 660	RSV+Flu Pooled Group n = 438	Flu+Placebo Group n = 439
Pain	53.6 (49.7 to 57.5)	51.1 (46.4 to 55.9)	34.4 (30 to 39)
Erythema	4.4 (3 to 6.2)	3.7 (2.1 to 5.9)	0.5 (0.1 to 1.6)
Swelling	4.5 (3.1 to 6.4)	4.6 (2.8 to 7)	0.9 (0.2 to 2.3)

Population analysed: Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set \[ES\]) and who have solicited safety data.

Primary outcome: Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Time frame: From Day 1 to Day 7 (including Day 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV Pooled Group n = 660	RSV+Flu Pooled Group n = 438	Flu+Placebo Group n = 439
Fatigue	52 (48.1 to 55.8)	59.8 (55.1 to 64.4)	51.9 (47.1 to 56.7)
Headache	47.6 (43.7 to 51.5)	51.4 (46.6 to 56.1)	43.1 (38.4 to 47.8)
Nausea	14.5 (11.9 to 17.5)	15.3 (12.1 to 19)	12.3 (9.4 to 15.7)
Vomiting	2.3 (1.3 to 3.7)	1.8 (0.8 to 3.6)	2.3 (1.1 to 4.1)
Diarrhea	12.1 (9.7 to 14.9)	13 (10 to 16.5)	17.1 (13.7 to 20.9)
Abdominal pain	12 (9.6 to 14.7)	13.5 (10.4 to 17)	14.1 (11 to 17.7)
Temperature	2.4 (1.4 to 3.9)	3 (1.6 to 5)	0.7 (0.1 to 2)

Primary outcome: Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Time frame: From Day 1 to Day 30 (including Day 30). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV Pooled Group n = 661	RSV+Flu Pooled Group n = 438	Flu+Placebo Group n = 440
Value	26.6 (23.3 to 30.2)	30.1 (25.9 to 34.7)	25.7 (21.7 to 30)

Population analysed: Analysis was performed on the ES (Exposed Set), which includes all participants who received at least 1 dose of the study treatment.

Primary outcome: Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Time frame: From Day 1 to Day 30 (including Day 30). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSV Pooled Group n = 661	RSV+Flu Pooled Group n = 438	Flu+Placebo Group n = 440
Value	0.2 (0 to 0.8)	0 (0 to 0.8)	0.2 (0 to 1.3)

Population analysed: Analysis was performed on the ES, which includes all participants who received at least 1 dose of the study treatment.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSV lot1 Group	2 of 220 (0.9%)	182 of 220 (82.7%)	0 of 220
RSV lot2 Group	1 of 223 (0.4%)	193 of 223 (86.5%)	0 of 223
RSV lot3 Group	2 of 218 (0.9%)	194 of 218 (89%)	0 of 218
RSV+Flu Pooled Group	4 of 438 (0.9%)	409 of 438 (93.4%)	0 of 438
Flu+Placebo Group	4 of 440 (0.9%)	396 of 440 (90%)	0 of 440

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38970327Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342.
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

36 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVPreF3(120 μg) and Flu Quadrivalent influenza vaccine (15 μg HA) in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 36 sites in 5 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 8 inclusion and 27 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Canada, Finland, Spain, United States, South Korea. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Oct 2023). 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 Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group (time frame: From Day 1 to Day 7 (including Day 7)). The study lists 7 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 NCT05045144, 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 Oct 2023.