A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women

Recruiting Phase 3 Interventional Study
Diphtheria-Tetanus-acellular Pertussis Vaccines
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
GlaxoSmithKline · Industry
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About This Trial

The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. Both the pregnant women and their neonates born during the study will be evaluated for specific analyses.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. Participants and Legally acceptable representative(s) \[LAR(s)\] who give physical or digital informed consent after the study has been explained according to …
Contacts

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

CONTACT

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

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