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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2004-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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undecavalent pneumococcal-protein D conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

27 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brno, , Czechia

Site Status

GSK Investigational Site

České Budějovice, , Czechia

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GSK Investigational Site

Děčín, , Czechia

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GSK Investigational Site

Fryštát, , Czechia

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Frýdek-Místek, , Czechia

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Havlíčkův Brod, , Czechia

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Hlinsko, , Czechia

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Jičín, , Czechia

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Jindřichův Hradec, , Czechia

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Litoměřice, , Czechia

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Náchod, , Czechia

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Ostrava, , Czechia

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Pardubice, , Czechia

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GSK Investigational Site

Prague, , Czechia

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GSK Investigational Site

Prague, , Czechia

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GSK Investigational Site

Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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GSK Investigational Site

Ústí nad Labem, , Czechia

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Ústí nad Labem, , Czechia

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Znojmo, , Czechia

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GSK Investigational Site

Dolný Kubín, , Slovakia

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Dubnica nad Váhom, , Slovakia

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Košťany nad Turcom, , Slovakia

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Liptovský Hrádok, , Slovakia

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Liptovský Mikuláš, , Slovakia

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Martin, , Slovakia

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Námestovo, , Slovakia

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Nitra, , Slovakia

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Nová Dubnica, , Slovakia

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Nové Mesto nad Váhom, , Slovakia

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Nové Zámky, , Slovakia

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Považská Bystrica, , Slovakia

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Púchov, , Slovakia

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GSK Investigational Site

Ružomberok, , Slovakia

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GSK Investigational Site

Sučany, , Slovakia

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GSK Investigational Site

Štúrovo, , Slovakia

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GSK Investigational Site

Šurany, , Slovakia

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GSK Investigational Site

Trenčín, , Slovakia

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GSK Investigational Site

Zlaté Moravce, , Slovakia

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Countries

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Czechia Slovakia

References

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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.

Reference Type BACKGROUND

PMID: 19446194 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21123523 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16517274 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18602724 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17258357 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17258358 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19666154 (View on PubMed)

Study Documents

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