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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Haemophilus Influenzae Type b

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Hib conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

9 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes