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

Primary Purpose

Hepatitis A

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
undecavalent pneumococcal-protein D conjugate vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Prophylaxis pneumococcal vaccine

Eligibility Criteria

6 Weeks - 27 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
July 6, 2005
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00119743
Brief Title
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2000 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
Prophylaxis pneumococcal vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
5000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
undecavalent pneumococcal-protein D conjugate vaccine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
27 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
628 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 71
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Decin
ZIP/Postal Code
405 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Frydek-Mistek
ZIP/Postal Code
738 02
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Hlinsko v Cechach
ZIP/Postal Code
539 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Jicin
ZIP/Postal Code
506 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Karvina
ZIP/Postal Code
734 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Litomerice
ZIP/Postal Code
412 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
728 92
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Usti nad Labem
ZIP/Postal Code
400 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Usti nad Labem
ZIP/Postal Code
400 78
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Znojmo
ZIP/Postal Code
669 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Dolny Kubin
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dubnica Nad Vahom
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kostany Nad Turcom
ZIP/Postal Code
038 41
Country
Slovakia
Facility Name
GSK Investigational Site
City
Liptovsky Hradok
ZIP/Postal Code
033 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Liptovsky Mikulas
ZIP/Postal Code
031 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Namestovo
ZIP/Postal Code
029 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nitra
ZIP/Postal Code
949 11
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nova Dubnica
ZIP/Postal Code
018 51
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nove Mesto nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Puchov
ZIP/Postal Code
020 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Ruzomberok
ZIP/Postal Code
034 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Sucany
ZIP/Postal Code
038 42
Country
Slovakia
Facility Name
GSK Investigational Site
City
Surany
ZIP/Postal Code
942 18
Country
Slovakia
Facility Name
GSK Investigational Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Zlate Moravce
ZIP/Postal Code
953 01
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
19446194
Citation
Poolman J, Kriz P, Feron C, Di-Paolo E, Henckaerts I, Miseur A, Wauters D, Prymula R, Schuerman L. Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine. 2009 May 21;27(24):3213-22. doi: 10.1016/j.vaccine.2009.03.017. Epub 2009 Mar 26.
Results Reference
background
PubMed Identifier
21123523
Citation
Poolman J, Frasch C, Nurkka A, Kayhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.
Results Reference
background
PubMed Identifier
16517274
Citation
Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, Kohl I, Lommel P, Poolman J, Prieels JP, Schuerman L. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet. 2006 Mar 4;367(9512):740-8. doi: 10.1016/S0140-6736(06)68304-9.
Results Reference
background
PubMed Identifier
18602724
Citation
Prymula R, Chlibek R, Splino M, Kaliskova E, Kohl I, Lommel P, Schuerman L. Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines. Vaccine. 2008 Aug 18;26(35):4563-70. doi: 10.1016/j.vaccine.2008.05.080. Epub 2008 Jun 17.
Results Reference
background
PubMed Identifier
17258357
Citation
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. doi: 10.1016/j.vaccine.2006.12.008. Epub 2006 Dec 26.
Results Reference
background
PubMed Identifier
17258358
Citation
Schuerman L, Prymula R, Chrobok V, Dieussaert I, Poolman J. Kinetics of the immune response following pneumococcal PD conjugate vaccination. Vaccine. 2007 Mar 1;25(11):1953-61. doi: 10.1016/j.vaccine.2006.12.007. Epub 2006 Dec 26.
Results Reference
background
PubMed Identifier
19666154
Citation
Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
347414/010
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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