Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age. TdaP2gen, a newly developed combined tetanus, diphtheria, and recombinant genetically detoxified acellular pertussis vaccine containing 2 µg pertussis antigen, has shown favorable safety and non-inferior immunogenicity compared with existing pertussis vaccines. However, data on its use in pregnant women, transplacental antibody transfer, and potential immune interference in infants remain limited. This study aims to evaluate the safety and immunogenicity of TdaP2gen in pregnant women, assess antibody transfer to newborns, and investigate immune responses to tetanus, diphtheria, and pertussis following primary and booster pertussis-containing vaccinations in infants and toddlers, including comparisons between whole-cell and acellular pertussis-containing vaccine schedules.
Age range
0 Days – 45 Years
Sex
ALL
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Phase 1: Maternal anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid, and anti-tetanus toxoid immunoglobulin G (IgG) geometric mean concentrations and seroresponse rates following TdaP2gen vaccination during pregnancy
Timeframe: Pre-vaccination baseline, 4 weeks after vaccination (+/- 14 days), and at delivery
Phase 1: Cord blood anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates at birth
Timeframe: At delivery
Phase 1: Incidence of solicited local and systemic adverse events, serious adverse events, and adverse pregnancy outcomes of TdaP2gen vaccination during pregnancy
Timeframe: From vaccination until delivery, assessed up to approximately 22 weeks post-vaccination.
Phase 2: Infant anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates following primary diphtheria-tetanus-pertussis vaccination series
Timeframe: Pre-primary series vaccination (within 2 months after birth) and post-primary series vaccination (at age 7 months +/- 14 days)
Phase 3: Infant anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates following booster diphtheria-tetanus-pertussis vaccination
Timeframe: At 12 months of age (+/- 14 days), pre-booster vaccination, and 1 month after booster vaccination (+/- 14 days)