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

NCT00119743 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2017-03-23

No results posted yet for this study

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

BIOLOGICAL

undecavalent pneumococcal-protein D conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
27 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2004-06-30
Completion
2004-06-30

Countries

  • Czechia
  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00119743 on ClinicalTrials.gov