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:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00197782
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   9 Months to 4 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197782

Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth Miller, MBBS FRCPath Health Protection Agency, United Kingdom
  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
Study First Received: September 12, 2005
Last Updated: March 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014