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

Infections, Streptococcal Clinical Trial

Official title:
Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

Clinical Trial 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.

Clinical Trial Description

The study will also evaluate the impact of the pneumococcal vaccine GSK2189242A on nasopharyngeal carriage in a subgroup of children called Carriage subgroup. Immunogenicity and reactogenicity of the pneumococcal vaccine GSK2189242A will be evaluated in another subgroup of children called Immuno/reacto subgroup.

Protocol Posting has been updated following Protocol Amendment 3, April 2012, leading to the addition of a secondary outcome measure.

Protocol Posting has been updated following Protocol Amendment 7, March 2017, to add serological testing for antibodies against the Hib polysaccharide PRP on samples collected 12 months following booster dose (Month 22) in the Immuno/reacto sub-cohort, in order to evaluate the long term persistence of immune responses to co-administered PedvaxHIB vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01545375
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date May 21, 2012
Completion date July 26, 2016
View Details
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