A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
March 21, 2017 updated by: GlaxoSmithKline
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
5000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brno, Czech Republic, 628 00
- GSK Investigational Site
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Ceske Budejovice, Czech Republic, 370 71
- GSK Investigational Site
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Decin, Czech Republic, 405 01
- GSK Investigational Site
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Frydek-Mistek, Czech Republic, 738 02
- GSK Investigational Site
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Havlickuv Brod, Czech Republic, 580 22
- GSK Investigational Site
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Hlinsko v Cechach, Czech Republic, 539 01
- GSK Investigational Site
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Jicin, Czech Republic, 506 01
- GSK Investigational Site
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Jindrichuv Hradec, Czech Republic, 377 01
- GSK Investigational Site
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Karvina, Czech Republic, 734 01
- GSK Investigational Site
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Litomerice, Czech Republic, 412 01
- GSK Investigational Site
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Nachod, Czech Republic, 547 01
- GSK Investigational Site
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Ostrava, Czech Republic, 728 92
- GSK Investigational Site
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Pardubice, Czech Republic, 532 03
- GSK Investigational Site
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Praha 2, Czech Republic, 120 00
- GSK Investigational Site
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Praha 4, Czech Republic, 140 00
- GSK Investigational Site
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Praha 5, Czech Republic, 150 06
- GSK Investigational Site
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Praha 6, Czech Republic, 160 00
- GSK Investigational Site
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Praha 8, Czech Republic, 180 00
- GSK Investigational Site
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Praha 9, Czech Republic, 190 00
- GSK Investigational Site
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Usti nad Labem, Czech Republic, 400 01
- GSK Investigational Site
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Usti nad Labem, Czech Republic, 400 78
- GSK Investigational Site
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Znojmo, Czech Republic, 669 00
- GSK Investigational Site
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Dolny Kubin, Slovakia, 026 01
- GSK Investigational Site
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Dubnica Nad Vahom, Slovakia, 018 41
- GSK Investigational Site
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Kostany Nad Turcom, Slovakia, 038 41
- GSK Investigational Site
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Liptovsky Hradok, Slovakia, 033 01
- GSK Investigational Site
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Liptovsky Mikulas, Slovakia, 031 01
- GSK Investigational Site
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Martin, Slovakia, 036 01
- GSK Investigational Site
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Namestovo, Slovakia, 029 01
- GSK Investigational Site
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Nitra, Slovakia, 949 11
- GSK Investigational Site
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Nova Dubnica, Slovakia, 018 51
- GSK Investigational Site
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Nove Mesto nad Vahom, Slovakia, 915 01
- GSK Investigational Site
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Nove Zamky, Slovakia, 940 01
- GSK Investigational Site
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Povazska Bystrica, Slovakia, 017 01
- GSK Investigational Site
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Puchov, Slovakia, 020 01
- GSK Investigational Site
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Ruzomberok, Slovakia, 034 01
- GSK Investigational Site
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Sturovo, Slovakia, 943 01
- GSK Investigational Site
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Sucany, Slovakia, 038 42
- GSK Investigational Site
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Surany, Slovakia, 942 18
- GSK Investigational Site
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Trencin, Slovakia, 911 01
- GSK Investigational Site
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Zlate Moravce, Slovakia, 953 01
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
July 6, 2005
First Submitted That Met QC Criteria
July 6, 2005
First Posted (Estimate)
July 14, 2005
Study Record Updates
Last Update Posted (Actual)
March 23, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 347414/010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
Study Data/Documents
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Clinical Study Report
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 347414/010Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.