A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

Summary

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Timeline

Start

2017-10-12

Primary completion

2019-05-24

Completion

2019-05-24

Publications

• Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.

Drugs

Indications