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

Hepatitis A Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00119743
• Other study ID #: 347414/010
• 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
• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Otitis Media

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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