Study of a vaccine for reducing ear and lung infections in children
The bacteria, Streptococcus pneumoniae (pneumococcus) can cause serious diseases such as pneumonia, meningitis, and bloodstream infections. It is also a major cause of ear infections in children. Since the mid-1980s, Johns Hopkins programs on the Navajo and White Mountain Apache reservations have worked to ease the burden of serious illnesses caused by the pneumococcal bacteria, especially in very young children.
Over 90 different types of the pneumococcal bacteria have been identified but the current licensed pediatric vaccine (Prevnar-13) protects against only 13 of those types. New vaccines have been developed that may provide protection against a broader range of pneumococcal types. Such vaccines could potentially reduce the burden of pneumococcal disease among American Indians. The Center for American Indian Health is evaluating one such vaccine.
About the pneumococcal vaccine study
This trial aims to determine whether an investigational pneumococcal vaccine can prevent ear infections and lower respiratory tract infections in children less than 2 years of age.
Babies enrolled into the study are vaccinated with all routine immunizations and also receive 4 doses of study vaccine or placebo. Children are followed through 2 years of age for ear infections and lower respiratory tract infections. The study will also assess the vaccine’s impact on carriage or the presence of the pneumococcal bacteria in the back of children's noses and on antibody levels. A total of 1,804 babies were enrolled into the study. Participant follow-up ended in August 2016 and results for the study are anticipated in 2017.
Funder = GlaxoSmithKline (GSK)