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