This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL
Time frame: 30 days after the booster dose
Incidence of solicited local and systemic adverse events (AEs)
Time frame: Within 7 days after each dose of vaccination
Incidence of unsolicited adverse events
Time frame: Within 30 days after each dose of vaccination
The number of serious adverse events (SAEs)
Time frame: Through study completion, an average of 16-19 months
The geometric mean concentration (GMC) of Serotype-specific IgG in all participants
Time frame: Before vaccination and 30 days after the booster dose
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort A participants
Time frame: 30 days after the primary series
Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort B participants
Time frame: Before the booster dose
The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort A participants
Time frame: 30 days after the primary series
The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort B participants
Time frame: Before the booster dose
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