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

Phase 3

Terminated

• Conditions: Hepatitis A

• Registration Number: NCT00119743
• Lead Sponsor: GlaxoSmithKline

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2005-07-06
• Study First Submitted QC: 2005-07-06
• Study First Posted: 2005-07-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇰 Zlate Moravce, Slovakia