NCT05169905

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

A Phase III, Randomized, Open-label, Active Vaccine-controlled Crossover Study to Evaluate the Reactogenicity, Safety and Immune Response of Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Girls From 9 to 17 Years of Age, and in Non-pregnant Adult Women From 18 to 49 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 9 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	RSV MAT vaccine	Single dose of the RSV MAT vaccine reconstituted with NaCl solution was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule. RSV MAT vaccine was no longer administered to participants at Day 31. No vaccine was administered in the dTpa\_RSV-P Group, since there were no participants assigned to it.
COMBINATION_PRODUCT	dTpa vaccine	Single dose of the dTpa vaccine was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule. Two formulations of dTpa vaccine are licensed in the US and outside of the US (ex-US), respectively. dTpa-US formulation was administered to participants in centers located in the US, while dTpa-ex-US formulation was planned to be administered to participants in centers ex-US. The dTpa-ex-US formulation was not applicable in this study anymore as no non-US sites were initiated before the decision to stop the study. The participants in RSV\_dTpa-P and RSV\_dTpa-A study groups were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization. No vaccine was administered in the dTpa\_RSV-P Group, since there were no participants assigned to it.

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-12-27
• Last updated: 2023-04-07
• Results posted: 2023-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study