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

PHASE3CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

February 2, 2022

Primary Completion Date

August 3, 2022

Study Completion Date

August 3, 2022

Conditions
Respiratory Syncytial Virus Infections
Interventions
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."

Trial Locations (2)

33142

GSK Investigational Site, Miami

77706

GSK Investigational Site, Beaumont

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

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 | Biotech Hunter | Biotech Hunter