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
  Purpose

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).


Condition Intervention Phase
Otitis Media
Biological: undecavalent pneumococcal-protein D conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 5000
Study Start Date: October 2000
Intervention Details:
    Biological: undecavalent pneumococcal-protein D conjugate vaccine
    Other Name: undecavalent pneumococcal-protein D conjugate vaccine
  Eligibility

Ages Eligible for Study:   6 Weeks to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119743

Locations
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 628 00
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 71
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Frydek-Mistek, Czech Republic, 738 02
GSK Investigational Site
Havlickuv Brod, Czech Republic, 580 22
GSK Investigational Site
Hlinsko v Cechach, Czech Republic, 539 01
GSK Investigational Site
Jicin, Czech Republic, 506 01
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
GSK Investigational Site
Karvina, Czech Republic, 734 01
GSK Investigational Site
Litomerice, Czech Republic, 412 01
GSK Investigational Site
Ostrava, Czech Republic, 728 92
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 2, Czech Republic, 120 00
GSK Investigational Site
Praha 4, Czech Republic, 140 00
GSK Investigational Site
Praha 5, Czech Republic, 150 06
GSK Investigational Site
Praha 6, Czech Republic, 160 00
GSK Investigational Site
Praha 8, Czech Republic, 180 00
GSK Investigational Site
Praha 9, Czech Republic, 190 00
GSK Investigational Site
Usti nad Labem, Czech Republic, 400 78
GSK Investigational Site
Usti nad Labem, Czech Republic, 400 01
GSK Investigational Site
Znojmo, Czech Republic, 669 00
Slovakia
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Dubnica Nad Vahom, Slovakia, 018 41
GSK Investigational Site
Kostany Nad Turcom, Slovakia, 038 41
GSK Investigational Site
Liptovsky Hradok, Slovakia, 033 01
GSK Investigational Site
Liptovsky Mikulas, Slovakia, 031 01
GSK Investigational Site
Martin, Slovakia, 036 01
GSK Investigational Site
Namestovo, Slovakia, 029 01
GSK Investigational Site
Nitra, Slovakia, 949 11
GSK Investigational Site
Nova Dubnica, Slovakia, 018 51
GSK Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
GSK Investigational Site
Nove Zamky, Slovakia, 940 01
GSK Investigational Site
Povazska Bystrica, Slovakia, 017 01
GSK Investigational Site
Puchov, Slovakia, 020 01
GSK Investigational Site
Ruzomberok, Slovakia, 034 01
GSK Investigational Site
Sturovo, Slovakia, 943 01
GSK Investigational Site
Sucany, Slovakia, 038 42
GSK Investigational Site
Surany, Slovakia, 942 18
GSK Investigational Site
Trencin, Slovakia, 911 01
GSK Investigational Site
Zlate Moravce, Slovakia, 953 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00119743     History of Changes
Other Study ID Numbers: 347414/010
Study First Received: July 6, 2005
Last Updated: November 21, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Prophylaxis pneumococcal vaccine

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014