NCT01545375

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,806 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK2189242A	4 doses administered intramuscularly
BIOLOGICAL	Placebo	4 doses administered intramuscularly
BIOLOGICAL	Prevnar 13®	4 doses administered intramuscularly
BIOLOGICAL	PedvaxHIB®	4 doses administered intramuscularly

Timeline

• Start date: 2012-05-21
• Primary completion: 2016-07-26
• Completion: 2016-07-26
• First posted: 2012-03-06
• Last updated: 2019-12-27
• Results posted: 2017-09-12

Locations

5 sites across 1 country: United States