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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00119743
Other study ID # 347414/010
Secondary ID
Status Terminated
Phase Phase 3
First received July 6, 2005
Last updated March 21, 2017
Start date October 2000
Est. completion date June 2004

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 5000
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 27 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
undecavalent pneumococcal-protein D conjugate vaccine


Locations

Country Name City State
Czech Republic GSK Investigational Site Brno
Czech Republic GSK Investigational Site Ceske Budejovice
Czech Republic GSK Investigational Site Decin
Czech Republic GSK Investigational Site Frydek-Mistek
Czech Republic GSK Investigational Site Havlickuv Brod
Czech Republic GSK Investigational Site Hlinsko v Cechach
Czech Republic GSK Investigational Site Jicin
Czech Republic GSK Investigational Site Jindrichuv Hradec
Czech Republic GSK Investigational Site Karvina
Czech Republic GSK Investigational Site Litomerice
Czech Republic GSK Investigational Site Nachod
Czech Republic GSK Investigational Site Ostrava
Czech Republic GSK Investigational Site Pardubice
Czech Republic GSK Investigational Site Praha 2
Czech Republic GSK Investigational Site Praha 4
Czech Republic GSK Investigational Site Praha 5
Czech Republic GSK Investigational Site Praha 6
Czech Republic GSK Investigational Site Praha 8
Czech Republic GSK Investigational Site Praha 9
Czech Republic GSK Investigational Site Usti nad Labem
Czech Republic GSK Investigational Site Usti nad Labem
Czech Republic GSK Investigational Site Znojmo
Slovakia GSK Investigational Site Dolny Kubin
Slovakia GSK Investigational Site Dubnica Nad Vahom
Slovakia GSK Investigational Site Kostany Nad Turcom
Slovakia GSK Investigational Site Liptovsky Hradok
Slovakia GSK Investigational Site Liptovsky Mikulas
Slovakia GSK Investigational Site Martin
Slovakia GSK Investigational Site Namestovo
Slovakia GSK Investigational Site Nitra
Slovakia GSK Investigational Site Nova Dubnica
Slovakia GSK Investigational Site Nove Mesto nad Vahom
Slovakia GSK Investigational Site Nove Zamky
Slovakia GSK Investigational Site Povazska Bystrica
Slovakia GSK Investigational Site Puchov
Slovakia GSK Investigational Site Ruzomberok
Slovakia GSK Investigational Site Sturovo
Slovakia GSK Investigational Site Sucany
Slovakia GSK Investigational Site Surany
Slovakia GSK Investigational Site Trencin
Slovakia GSK Investigational Site Zlate Moravce

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Czech Republic,  Slovakia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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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