Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects

Summary

Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy Russian subjects. An equal number of subjects are expected to be recruited in the following age categories: 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis diseases.

Timeline

Start

2018-01-26

Primary completion

2018-08-31

Completion

2018-08-31

Publications

• Background Asatryan A, Meyer N, Scherbakov M, Romanenko V, Osipova I, Galustyan A, Shamsheva O, Latysheva T, Myasnikova T, Baudson N, Dodet M, Xavier S, Harrington L, Kuznetsova A, Campora L, Van den Steen P. Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study. Hum Vaccin Immunother. 2021 Mar 4;17(3):723-730. doi: 10.1080/21645515.2020.1796423. Epub 2020 Aug 26.

Drugs

Indications

No indication recorded.