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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00119743
First received: July 6, 2005
Last updated: November 21, 2012
Last verified: November 2012

July 6, 2005
November 21, 2012
October 2000
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00119743 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Otitis Media
Biological: undecavalent pneumococcal-protein D conjugate vaccine
Other Name: undecavalent pneumococcal-protein D conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5000
Not Provided
Not Provided

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.
Both
6 Weeks to 27 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Slovakia
 
NCT00119743
347414/010
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP