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Status:

COMPLETED

Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

Lead Sponsor:

GlaxoSmithKline

Conditions:

Whole Cell Pertussis

Haemophilus Influenzae Type b

Eligibility:

All Genders

427-730 years

Phase:

PHASE3

Brief Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of a...

Detailed Description

This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a sin...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Healthy male or female between and including 15 and 24 months of age
  • Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
  • Exclusion criteria:
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
  • History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.

Exclusion

    Key Trial Info

    Start Date :

    January 22 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 23 2006

    Estimated Enrollment :

    617 Patients enrolled

    Trial Details

    Trial ID

    NCT00136604

    Start Date

    January 22 2006

    End Date

    April 23 2006

    Last Update

    February 20 2020

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    GSK Investigational Site

    Bangkok, Thailand, 10400

    2

    GSK Investigational Site

    Khon Kaen, Thailand, 40002

    3

    GSK Investigational Site

    Songkhla, Thailand, 90110