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Status:

COMPLETED

Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine

Lead Sponsor:

GlaxoSmithKline

Conditions:

Haemophilus Influenzae Type b

Neisseria Meningitidis

Eligibility:

All Genders

6-12 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-ad...

Detailed Description

This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). The study will be conducted in two stages. Primary vaccination ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Healthy male or female, between, and including, 6 and 12 weeks of age.
  • Born after a gestation period between 36 and 42 weeks
  • Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory
  • Exclusion criteria:
  • Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
  • History of H. influenzae type b and /or meningococcal serogroup C disease.
  • Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • A family history of congenital or hereditary immunodeficiency
  • History of any neurologic disorders or seizures
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    478 Patients enrolled

    Trial Details

    Trial ID

    NCT00258700

    Start Date

    February 1 2005

    End Date

    July 1 2006

    Last Update

    September 21 2016

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    GSK Investigational Site

    Bydgoszcz, Poland, 85-021

    2

    GSK Investigational Site

    Gdansk, Poland, 80-394

    3

    GSK Investigational Site

    Kielce, Poland, 25-711

    4

    GSK Investigational Site

    Krakow, Poland, 31-202