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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197782
First Posted: September 20, 2005
Last Update Posted: March 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
  Purpose
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 Intervention Phase
Haemophilus Influenzae Type b Biological: Hib conjugate vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Dr. Elizabeth Miller, Health Protection Agency, United Kingdom:

Study Start Date: April 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: Dr. Elizabeth Miller, consultant epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00197782     History of Changes
Other Study ID Numbers: Hibboost
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: March 28, 2012
Last Verified: March 2012

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