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Considerations for a Phase III Trial to Evaluate a Group B Streptococcus Polysaccharide-Protein Conjugate Vaccine in Pregnant Women for the Prevention of Early- and Late-Onset Invasive Disease in Young Infants

This article, published in Vaccine, discusses the global disease burden of group B Streptococcus (GBS) and strategies to combat the disease. The authors argue that vaccination is a promising strategy, particularly in low-income countries where intra-partum antibiotic prophylaxis options are logistically difficult to implement. The article discusses a trivalent GBS polysaccharide-protein conjugate vaccine undergoing Phase 2 study in pregnant women in North America, Europe, and Africa, and summarizes key discussion points from a scientific meeting on how to plan a Phase 3 study for this vaccine candidate. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)

Author: Madhi SA, Dangor Z, Heath PT, et al.

Published: 2013

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(Located at www.sciencedirect.com)

Citation: Madhi SA, Dangor Z, Heath PT, et al. Considerations for a Phase III Trial to Evaluate a Group B Streptococcus Polysaccharide-Protein Conjugate Vaccine in Pregnant Women for the Prevention of Early- and Late-Onset Invasive Disease in Young Infants. Vaccine. 2013;31(Suppl 4):D52-D57. 

Resource types: Peer-reviewed journal

Diseases/vaccines: Group B Streptococcus (GBS)

Topics: Disease burden and surveillance, Vaccine safety and performance, Disease/vaccine specific information

Regions: Global