NCT00119743

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

Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media (AOM) of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine, When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 27 Months
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	undecavalent pneumococcal-protein D conjugate vaccine

Timeline

• Start date: 2000-10-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2005-07-14
• Last updated: 2017-03-23

Locations

41 sites across 2 countries: Czechia, Slovakia