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.
1 other identifier
interventional
5,000
2 countries
41
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2000
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 6, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedMarch 23, 2017
March 1, 2017
3.7 years
July 6, 2005
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (41)
GSK Investigational Site
Brno, 628 00, Czechia
GSK Investigational Site
České Budějovice, 370 71, Czechia
GSK Investigational Site
Děčín, 405 01, Czechia
GSK Investigational Site
Fryštát, 734 01, Czechia
GSK Investigational Site
Frýdek-Místek, 738 02, Czechia
GSK Investigational Site
Havlíčkův Brod, 580 22, Czechia
GSK Investigational Site
Hlinsko, 539 01, Czechia
GSK Investigational Site
Jičín, 506 01, Czechia
GSK Investigational Site
Jindřichův Hradec, 377 01, Czechia
GSK Investigational Site
Litoměřice, 412 01, Czechia
GSK Investigational Site
Náchod, 547 01, Czechia
GSK Investigational Site
Ostrava, 728 92, Czechia
GSK Investigational Site
Pardubice, 532 03, Czechia
GSK Investigational Site
Prague, 120 00, Czechia
GSK Investigational Site
Prague, 140 00, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Prague, 160 00, Czechia
GSK Investigational Site
Prague, 180 00, Czechia
GSK Investigational Site
Prague, 190 00, Czechia
GSK Investigational Site
Ústí nad Labem, 400 01, Czechia
GSK Investigational Site
Ústí nad Labem, 400 78, Czechia
GSK Investigational Site
Znojmo, 669 00, Czechia
GSK Investigational Site
Dolný Kubín, 026 01, Slovakia
GSK Investigational Site
Dubnica nad Váhom, 018 41, Slovakia
GSK Investigational Site
Košťany nad Turcom, 038 41, Slovakia
GSK Investigational Site
Liptovský Hrádok, 033 01, Slovakia
GSK Investigational Site
Liptovský Mikuláš, 031 01, Slovakia
GSK Investigational Site
Martin, 036 01, Slovakia
GSK Investigational Site
Námestovo, 029 01, Slovakia
GSK Investigational Site
Nitra, 949 11, Slovakia
GSK Investigational Site
Nová Dubnica, 018 51, Slovakia
GSK Investigational Site
Nové Mesto nad Váhom, 915 01, Slovakia
GSK Investigational Site
Nové Zámky, 940 01, Slovakia
GSK Investigational Site
Považská Bystrica, 017 01, Slovakia
GSK Investigational Site
Púchov, 020 01, Slovakia
GSK Investigational Site
Ružomberok, 034 01, Slovakia
GSK Investigational Site
Sučany, 038 42, Slovakia
GSK Investigational Site
Štúrovo, 943 01, Slovakia
GSK Investigational Site
Šurany, 942 18, Slovakia
GSK Investigational Site
Trenčín, 911 01, Slovakia
GSK Investigational Site
Zlaté Moravce, 953 01, Slovakia
Related Publications (7)
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.
PMID: 19446194BACKGROUNDPoolman 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.
PMID: 21123523BACKGROUNDPrymula 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.
PMID: 16517274BACKGROUNDPrymula 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.
PMID: 18602724BACKGROUNDSchuerman 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.
PMID: 17258357BACKGROUNDSchuerman 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.
PMID: 17258358BACKGROUNDSchuerman 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.
PMID: 19666154BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2005
First Posted
July 14, 2005
Study Start
October 1, 2000
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.