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.
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Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL
Timeframe: 30 days after the booster dose
Incidence of solicited local and systemic adverse events (AEs)
Timeframe: Within 7 days after each dose of vaccination