Diphtheria-Tetanus-acellular Pertussis Vaccines Clinical Trial
Official title:
Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women
The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].
The protocol was amended to include Spain in the study. The reasons for the Spain-specific
amendment are listed below:
- Based on the feedback from the Spanish Ethics Committee, the evaluation related to the
acceptance of cocooning was added in the protocol.
- The objectives and endpoints to include cocooning were added in the protocol.
- The eligibility criteria for participation of household contacts were defined in the
protocol.
- The study procedures for household contacts were included.
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