Table 6.
Safety |
1. The association between receipt of Tdap in pregnancy and chorioamnionitis |
Immunogenicity |
1. Assessment of immune correlates for protection against pertussis disease (e.g., Bordetella pertussis –specific antibody levels) |
2. Bordetella pertussis antigens to be included in pertussis vaccines for maternal immunization to provide sufficient clinical protection to the infant |
3. The need for immunization against pertussis disease in subsequent (3rd or more) pregnancies. |
4. Comparative studies comparing different pertussis vaccine formulations (e.g., Tdap vs. aP stand-alone vaccines) |
5. Role of previous vaccination of the mother with whole cell or aP vaccines in the immune response to maternal pertussis vaccination |
Timing |
1. The effect of timing of vaccination on the function of anti-Bordetella pertussis antibodies transferred to infants |
2. The immunogenicity of stand-alone aP given in different times in pregnancy |
Effectiveness |
1. Burden of pertussis disease in infancy in low and middle-income countries |
2. The effectiveness of maternal immunization program in low and middle-income countries if pertussis immunization in pregnancy is implemented |
3. Assess the eventual role of previous vaccination with whole cell or acellular pertussis to the mother on vaccine effectiveness |
4. Vaccine effectiveness of various Tdap formulations |
Tdap, tetanus-diphtheria-acellular-pertussis; aP, acellular pertussis.