Stopped: Sponsor decision
This study is a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study to be conducted in 947 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study is to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.
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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)
Timeframe: Day 85
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85)
Timeframe: Day 85
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Timeframe: Within 30 minutes after each vaccination
Presence of solicited administration site reactions within 21 days after each vaccination
Timeframe: Within 21 days after each vaccination
Presence of solicited systemic reactions within 21 days after each vaccination
Timeframe: Within 21 days after each vaccination
Presence of unsolicited AEs within 28 days after each vaccination
Timeframe: Within 28 days after each vaccination
Presence of medically attended adverse events MAAEs throughout the study
Timeframe: Throughout the study (approximately 8 months)
Presence of serious adverse events (SAEs) throughout the study
Timeframe: Throughout the study (approximately 8 months)
Presence of adverse events of special interest (AESIs) throughout the study
Timeframe: Throughout the study (approximately 8 months)