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Virus Vaccine

RSV_dTpa-P 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 younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days post-rsv mat vaccine administration (day 31)
Awards & highlights

Study Summary

The purpose of this study was to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49 YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa) vaccine was planned to be used as an active control for safety and reactogenicity evaluation. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in this study. Enrolled study participants were monitored as part of the study until study completion.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days post-rsv mat vaccine administration (day 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days post-rsv mat vaccine administration (day 31) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal
Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal
Number of Participants Reporting Any Serious Adverse Events (SAEs)
+4 more
Secondary outcome measures
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: dTpa_RSV-P GroupExperimental Treatment2 Interventions
Healthy non-pregnant girls 9-17 years of age were scheduled to receive a single dose of dTpa vaccine at Day 1 and a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration), but there were no participants assigned to this study group, and hence, there was no vaccine administered in this study group.
Group II: dTpa_RSV-A GroupExperimental Treatment2 Interventions
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
Group III: RSV_dTpa-P GroupExperimental Treatment2 Interventions
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
Group IV: RSV_dTpa-A GroupExperimental Treatment2 Interventions
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dTpa vaccine
2022
Completed Phase 3
~10
RSV MAT vaccine
2022
Completed Phase 3
~10

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,807 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,921 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
2022. "A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169905.
~3 spots leftby Apr 2025
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