A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to rank different RSV vaccine dosages of antigen (or
      formulations) based on safety/reactogenicity and immune response data. The formulations
      eliciting strong immune responses while maintaining an acceptable safety profile will be
      considered for further evaluation, including in studies vaccinating pregnant women.
    

Detailed description: 
      The purpose of the RSV F-021 study that will be conducted in an observer-blind manner during
      Epoch 1 and single blinded during Epoch 2, is to rank the 3 different doses of the
      non-adjuvanted investigational RSV PreF-vaccine (30, 60 and 120 μg) based on
      safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30).
      Non-pregnant women aged 18-45 years will be randomized in a 1:1:1:1 ratio to receive one of
      three dose levels (30, 60, 120 μg) of the RSV PreF vaccine or placebo. The doses eliciting
      strong immune responses while maintaining an acceptable safety profile will be considered for
      further evaluation, including in studies vaccinating pregnant women. This will allow
      evaluation of a wider antigen dose range to determine if there is a dose response
      relationship in terms of antibody response at the higher dose range that was not present at
      the lower range.

      Since in RSV F-021 the 120ug dosage of the PreF-based investigational RSV vaccine will be
      tested for the first time in humans, appropriate safety monitoring is planned for this study,
      including pausing enrolment when the first 25% of subjects from each study group have been
      vaccinated until review of day 7 post-vaccination safety data by an unblinded GSK internal
      Safety Review Committee (iSRC) has been completed. The enrolment/vaccination of the remaining
      subjects can only start following the favourable outcome of this iSRC safety review.

      In addition to study visits at Day 0, Day 7 and Day 30 to evaluate primary objective of the
      study, additional study visits are planned at Day 60 and 90 for further investigation of the
      immunogenicity and safety/reactogenicity profile of the formulations. A follow-up period has
      been set up in which the subjects will be contacted at Day 180, 270 and 360. During these
      contacts, the investigator (or delegate) will ask the subject if she has experienced any
      serious adverse events and/or any AEs leading to study withdrawal since Day 90/last contact
      (as applicable), as well as if she has become pregnant during the post-vaccination period.
      The investigator (or delegate) will also ask the subject about concomitant
      vaccinations/products/medications that she has received since Day 90/last contact (as
      applicable) and whether the she had a respiratory tract infection that needed medical
      attention. Contact should be preferably performed via telephone, or alternatively, if phone
      contact is not possible, through email/other means where the information can be fully
      collected.

      Healthy, non-pregnant women aged 18 - 45 years will be enrolled in this study:

      Women aged 18 - 45 years are selected to match the vaccine's target population, i.e. pregnant
      women, as closely as possible (gender, age).

      Non-pregnant women are selected to avoid unnecessarily exposing a vulnerable population
      (pregnant women and the foetuses/children) to a higher dose of the vaccine that has not
      previously been studied in non-pregnant women.
    

Intervention name(s): RSV Vaccine (GSK3003891A) formulation 1; RSV Vaccine (GSK3003891A) formulation 2; RSV Vaccine (GSK3003891A) formulation 3; Placebo (Formulation buffer S9b)
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.; A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccines; Respiratory Syncytial Viruses; Safety; Reactogenicity; Ranking of Formulations; Immunogenicity