NCT00197782

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2003

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Last Update Submit

August 23, 2018

Conditions

Haemophilus Influenzae Type b

Interventions

Hib conjugate vaccineBIOLOGICAL

Eligibility Criteria

Age9 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Southern J, McVernon J, Gelb D, Andrews N, Morris R, Crowley-Luke A, Goldblatt D, Miller E. Immunogenicity of a fourth dose of Haemophilus influenzae type b (Hib) conjugate vaccine and antibody persistence in young children from the United Kingdom who were primed with acellular or whole-cell pertussis component-containing Hib combinations in infancy. Clin Vaccine Immunol. 2007 Oct;14(10):1328-33. doi: 10.1128/CVI.00191-07. Epub 2007 Aug 15.

    PMID: 17699835RESULT

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Elizabeth Miller, MBBS FRCPath

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant epidemiologist

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

August 24, 2018

Record last verified: 2018-08