← Back to Search

Vaccine

RSV lot3 Group for Respiratory Syncytial Virus

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

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 30 (including day 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 30 (including day 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

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
4,772 Previous Clinical Trials
8,105,317 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,142,694 Total Patients Enrolled
~414 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top