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.
The study duration is approximately 8 months for each participant, including the 6 months safety follow-up phone call after the second study intervention administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
947
Pharmaceutical form: Liquid for nasal spray Route of administration: Intranasal
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Investigational Site Number : 2140002
Santo Domingo, Dominican Republic
Investigational Site Number : 3400002
San Pedro Sula, Honduras
Investigational Site Number : 3400001
Tegucigalpa, Honduras
Investigational Site Number : 3400003
Tegucigalpa, Honduras
RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85)
Antibody titers are expressed as GMT at Day 85
Time frame: Day 85
RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85)
Antibody titers are expressed as GMT at Day 85
Time frame: Day 85
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Time frame: Within 30 minutes after each vaccination
Presence of solicited administration site reactions within 21 days after each vaccination
Number of participants experiencing solicited site reactions
Time frame: Within 21 days after each vaccination
Presence of solicited systemic reactions within 21 days after each vaccination
Number of participants experiencing solicited systemic reactions
Time frame: Within 21 days after each vaccination
Presence of unsolicited AEs within 28 days after each vaccination
Number of participants experiencing unsolicited AEs
Time frame: Within 28 days after each vaccination
Presence of medically attended adverse events MAAEs throughout the study
Number of participants experiencing MAAEs
Time frame: Throughout the study (approximately 8 months)
Presence of serious adverse events (SAEs) throughout the study
Number of participants experiencing SAEs
Time frame: Throughout the study (approximately 8 months)
Presence of adverse events of special interest (AESIs) throughout the study
Number of participants experiencing AESIs
Time frame: Throughout the study (approximately 8 months)
RSV A serum neutralizing antibody titers at baseline (D01) and D85
Antibody titers are expressed as GMTs at baseline and Day 85
Time frame: At baseline through Day 85
RSV B serum neutralizing antibody titers at baseline (D01) and D85
Antibody titers are expressed as GMTs at baseline and Day 85
Time frame: At baseline through Day 85
RSV serum anti-F Immunoglobulin A (IgA) at baseline (Day01) and D85
Antibody titers are expressed as GMTs at baseline and Day 85
Time frame: At baseline through Day 85
RSV serum anti-F Immunoglobulin G (IgG) at baseline (Day01) and D85
Antibody titers are expressed as GMTs at baseline and Day 85
Time frame: At baseline through Day 85
Presence of RSVt vaccine virus viral shedding in D08 and D64 nasal samples
Measured by quantitative real-time polymerase chain reaction (qRT PCR)
Time frame: Day 08 through Day 64
Titer of vaccine virus shedding in D08 and D64 nasal samples
Quantified by qRT-PCR
Time frame: Day 08 through day 64
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