Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.

ABSTRACT:

Importance

Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis.

Objective

To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.

Design, setting, and participants

Phase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum.

Interventions

Tdap vaccination at 30 to 32 weeks' gestation or postpartum.

Main outcomes and measures

Primary outcomes

SUBMITTER: Munoz FM 

PROVIDER: S-EPMC4333147 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature