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Vaccine

RSV lot3 Group for Respiratory Syncytial Virus Infection

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)

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

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 more

Secondary 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 more

Awards & 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