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Vaccine
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.
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 30 (including day 30)
Awards & highlights
Pivotal Trial
Summary
This trial tests the consistency and safety of an RSV vaccine when given with a flu vaccine. It targets healthy women aged 18-49. The vaccines help the immune system fight off respiratory viruses.
Eligible Conditions
- Respiratory Syncytial Virus Infection
- Respiratory Syncytial Virus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 30 (including day 30)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 30 (including day 30)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
+4 moreSecondary study objectives
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
RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group 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
+6 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: RSV+Flu pooled GroupExperimental Treatment1 Intervention
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.
Group II: RSV lot3 GroupExperimental Treatment1 Intervention
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.
Group III: RSV lot2 GroupExperimental Treatment1 Intervention
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.
Group IV: RSV lot1 GroupExperimental Treatment1 Intervention
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.
Group V: Flu+Placebo GroupActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3(120 μg)
2021
Completed Phase 3
~1590
Flu Quadrivalent influenza vaccine (15 μg HA)
2021
Completed Phase 3
~1590
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,812 Previous Clinical Trials
8,380,662 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,143,485 Total Patients Enrolled