A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Terminated
CT.gov ID
NCT00119743
Collaborator
(none)
5,000
41
44
122
2.8
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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.
Study Start Date
:
Oct 1, 2000
Actual Primary Completion Date
:
Jun 1, 2004
Actual Study Completion Date
:
Jun 1, 2004
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Weeks
to 27 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Brno | Czech Republic | 628 00 | |
| 2 | GSK Investigational Site | Ceske Budejovice | Czech Republic | 370 71 | |
| 3 | GSK Investigational Site | Decin | Czech Republic | 405 01 | |
| 4 | GSK Investigational Site | Frydek-Mistek | Czech Republic | 738 02 | |
| 5 | GSK Investigational Site | Havlickuv Brod | Czech Republic | 580 22 | |
| 6 | GSK Investigational Site | Hlinsko v Cechach | Czech Republic | 539 01 | |
| 7 | GSK Investigational Site | Jicin | Czech Republic | 506 01 | |
| 8 | GSK Investigational Site | Jindrichuv Hradec | Czech Republic | 377 01 | |
| 9 | GSK Investigational Site | Karvina | Czech Republic | 734 01 | |
| 10 | GSK Investigational Site | Litomerice | Czech Republic | 412 01 | |
| 11 | GSK Investigational Site | Nachod | Czech Republic | 547 01 | |
| 12 | GSK Investigational Site | Ostrava | Czech Republic | 728 92 | |
| 13 | GSK Investigational Site | Pardubice | Czech Republic | 532 03 | |
| 14 | GSK Investigational Site | Praha 2 | Czech Republic | 120 00 | |
| 15 | GSK Investigational Site | Praha 4 | Czech Republic | 140 00 | |
| 16 | GSK Investigational Site | Praha 5 | Czech Republic | 150 06 | |
| 17 | GSK Investigational Site | Praha 6 | Czech Republic | 160 00 | |
| 18 | GSK Investigational Site | Praha 8 | Czech Republic | 180 00 | |
| 19 | GSK Investigational Site | Praha 9 | Czech Republic | 190 00 | |
| 20 | GSK Investigational Site | Usti nad Labem | Czech Republic | 400 01 | |
| 21 | GSK Investigational Site | Usti nad Labem | Czech Republic | 400 78 | |
| 22 | GSK Investigational Site | Znojmo | Czech Republic | 669 00 | |
| 23 | GSK Investigational Site | Dolny Kubin | Slovakia | 026 01 | |
| 24 | GSK Investigational Site | Dubnica Nad Vahom | Slovakia | 018 41 | |
| 25 | GSK Investigational Site | Kostany Nad Turcom | Slovakia | 038 41 | |
| 26 | GSK Investigational Site | Liptovsky Hradok | Slovakia | 033 01 | |
| 27 | GSK Investigational Site | Liptovsky Mikulas | Slovakia | 031 01 | |
| 28 | GSK Investigational Site | Martin | Slovakia | 036 01 | |
| 29 | GSK Investigational Site | Namestovo | Slovakia | 029 01 | |
| 30 | GSK Investigational Site | Nitra | Slovakia | 949 11 | |
| 31 | GSK Investigational Site | Nova Dubnica | Slovakia | 018 51 | |
| 32 | GSK Investigational Site | Nove Mesto nad Vahom | Slovakia | 915 01 | |
| 33 | GSK Investigational Site | Nove Zamky | Slovakia | 940 01 | |
| 34 | GSK Investigational Site | Povazska Bystrica | Slovakia | 017 01 | |
| 35 | GSK Investigational Site | Puchov | Slovakia | 020 01 | |
| 36 | GSK Investigational Site | Ruzomberok | Slovakia | 034 01 | |
| 37 | GSK Investigational Site | Sturovo | Slovakia | 943 01 | |
| 38 | GSK Investigational Site | Sucany | Slovakia | 038 42 | |
| 39 | GSK Investigational Site | Surany | Slovakia | 942 18 | |
| 40 | GSK Investigational Site | Trencin | Slovakia | 911 01 | |
| 41 | GSK Investigational Site | Zlate Moravce | Slovakia | 953 01 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Poolman J, Frasch C, Nurkka A, Käyhty 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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. Epub 2006 Dec 26.
- 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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00119743
Other Study ID Numbers:
- 347414/010
First Posted:
Jul 14, 2005
Last Update Posted:
Mar 23, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms: