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

P

Public Health England

Status and phase

Completed
Phase 4

Conditions

Haemophilus Influenzae Type b

Treatments

Biological: Hib conjugate vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00197782
Hibboost

Details and patient eligibility

About

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.

Sex

All

Ages

9 months to 4 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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