The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.
Age range
18 Years – 45 Years
Sex
FEMALE
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Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]
Timeframe: From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs [Primary Study]
Timeframe: From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs [Primary Study]
Timeframe: From Day 1 to Day 31
Number of Subjects With Any SAEs [Primary Study]
Timeframe: From Day 1 to Day 31
Percentage of Subjects With Any Solicited Local AEs [Extension Study]
Timeframe: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects Any Solicited General AEs [Extension Period]
Timeframe: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects With Any Unsolicited AEs [Extension Period]
Timeframe: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
Number of Subjects With Any SAEs [Extension Period]
Timeframe: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]
Timeframe: At Screening (Day -7 to Day 1)
RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]
Timeframe: At Day 8
RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]
Timeframe: At Day 31
RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]
Timeframe: At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 [Primary Study]
Timeframe: At Day 8
RSV PreF3 IgG GMCs at Day 31 [Primary Study]
Timeframe: At Day 31