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

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ClinicalTrials.gov Identifier: NCT00197782
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Public Health England

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
Haemophilus Influenzae Type b Biological: Hib conjugate vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197782


Sponsors and Collaborators
Public Health England
Investigators
Principal Investigator: Elizabeth Miller, MBBS FRCPath Public Health England

Publications of Results:
Responsible Party: Dr. Elizabeth Miller, consultant epidemiologist, Public Health England
ClinicalTrials.gov Identifier: NCT00197782     History of Changes
Other Study ID Numbers: Hibboost
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs