Stopped: Sponsor decision
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Timeframe: Day 85
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3
Timeframe: Day 85
RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4
Timeframe: Day 113
RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4
Timeframe: Day 113