A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00119743

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 III

MedlinePlus related topics: Ear Infections

Drug Information available for: Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media 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

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

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

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

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Professor

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Schuerman L, Prymula R, Henckaerts I, Poolman J. ELISA IgG concentrations and opsonophagocytic activity following pneumococcal protein D conjugate vaccination and relationship to efficacy against acute otitis media. Vaccine. 2007 Mar 1;25(11):1962-8. Epub 2006 Dec 26.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	347414/010
Study First Received:	July 6, 2005
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00119743 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Prophylaxis pneumococcal vaccine

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

ClinicalTrials.gov processed this record on May 07, 2009