Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

Summary

The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.

Timeline

Start

2016-03-29

Primary completion

2016-11-02

Completion

2016-11-02

Publications

• Background Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, Buffi G, Margarit I, Karsten A, Cho S, Slobod K, Corsaro B, Henry O. Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial. Clin Infect Dis. 2020 Jun 10;70(12):2570-2579. doi: 10.1093/cid/ciz737.

Drugs

Indications