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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| undecavalent pneumococcal-protein D conjugate vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brno | 628 00 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19446194 | Background | 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. | |
| 21123523 | Background |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 347414/010 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
| 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. |
| 16517274 | Background | 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. |
| 18602724 | Background | 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. |
| 17258357 | Background | 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. |
| 17258358 | Background | 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. |
| 19666154 | Background | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 347414/010 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 347414/010 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 347414/010 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 347414/010 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 347414/010 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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