A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 3

Conditions

Hepatitis A

Treatments

Biological: undecavalent pneumococcal-protein D conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00119743

347414/010

Details and patient eligibility

About

The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).

Sex

All

Ages

6 weeks to 27 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.