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The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine

Sponsor
Public Health England (Other)
Overall Status
Completed
CT.gov ID
NCT00197782
Collaborator
(none)
32
Duration (Months)

Study Details

Study Description

Brief Summary

To measure the magnitude and persistence of the antibody response to a booster dose of Hib conjugate vaccine given between 9 months and 4 years of age to UK children who had completed primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.

Condition or Disease Intervention/Treatment Phase
  • Biological: Hib conjugate vaccine
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Months to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Written informed consent from parent or legal guardian of the infant or child

    • Age >= 9 months and <4 years at recruitment

    • Eligible to receive a single dose of Hib vaccine as per the UK schedule

    • Receipt of three doses of Hib vaccine in infancy

    Exclusion Criteria:

    • History of Hib infection

    • History of severe local reaction that can be confidently related to a prior Hib immunisation

    • Deferral of vaccination if acute illness and/or temperature >38C on day of vaccination

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Public Health England

    Investigators

    • Principal Investigator: Elizabeth Miller, MBBS FRCPath, Public Health England

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Elizabeth Miller, consultant epidemiologist, Public Health England
    ClinicalTrials.gov Identifier:
    NCT00197782
    Other Study ID Numbers:
    • Hibboost
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Aug 24, 2018
    Last Verified:
    Aug 1, 2018

    Study Results

    No Results Posted as of Aug 24, 2018