Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

Summary

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Timeline

Start

2012-05-21

Primary completion

2016-07-26

Completion

2016-07-26

Publications

• Background Hammitt LL, Campbell JC, Borys D, Weatherholtz RC, Reid R, Goklish N, Moulton LH, Traskine M, Song Y, Swinnen K, Santosham M, O'Brien KL. Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study. Vaccine. 2019 Dec 3;37(51):7482-7492. doi: 10.1016/j.vaccine.2019.09.076. Epub 2019 Oct 16.

Drugs

Indications