9
Participants
Start Date
February 2, 2022
Primary Completion Date
August 3, 2022
Study Completion Date
August 3, 2022
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."
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."
GSK Investigational Site, Miami
GSK Investigational Site, Beaumont
Lead Sponsor
GlaxoSmithKline
INDUSTRY