- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197782
The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine
August 23, 2018 updated by: Prof. Elizabeth Miller, Public Health England
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Miller, MBBS FRCPath, Public Health England
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
August 24, 2018
Last Update Submitted That Met QC Criteria
August 23, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Hibboost
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Haemophilus Influenzae Type b
-
GlaxoSmithKlineCompletedHaemophilus Influenzae Type b DiseaseChina
-
GlaxoSmithKlineCompletedHib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate VaccinesNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited Kingdom
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain, Germany, Poland
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
Clinical Trials on Hib conjugate vaccine
-
Jiangsu Province Centers for Disease Control and...Chengdu Olymvax Biopharmaceuticals Inc.CompletedHaemophilus Influenza
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisPhilippines
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisThailand
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedInfections, StreptococcalFinland
-
GlaxoSmithKlineCompletedStreptococcus Pneumoniae | Infections, StreptococcalIndia
-
University of OxfordUniversity College, London; Public Health EnglandCompleted
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisThailand
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisPhilippines
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisPhilippines