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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN71271385
Date of registration:	21/09/2000
Prospective Registration:	Yes
Primary sponsor:	Medical Research Council (MRC) (UK)
Public title:	A randomised trial of hepatitis B booster vaccination at the age of 13 to 15 years following infant vaccination to assess efficacy against hepatitis B infection and acute hepatitis
Scientific title:
Date of first enrolment:	01/01/2004
Target sample size:	500
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN71271385
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:

Countries of recruitment
Gambia

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Andrew J Hall
Address:	London School of Hygiene and Tropical Medicine Keppel Street WC1E 7HT London United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Added as of 23/04/2007:
1. ID and vaccination data matched with Gambia Hepatitis Intervention Study (GHIS) database
2. Born between 1/7/1988 and 31/12/1989
3. Living in selected Health Centre (HC) catchment area's
4. Informed consent participant and parent/guardian
Exclusion criteria: Added as of 23/04/2007:
1. No complete informed consent
2. No match found
3. Not fully vaccinated in infancy
4. Not in age range

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B Virus
Infections and Infestations
Hepatitis B

Intervention(s)

Added as of 23/04/2007:
Booster dose HBV vaccine

Primary Outcome(s)

Added as of 23/04/2007:
Anti-HBs titers after one year.

Secondary Outcome(s)

Added as of 23/04/2007:
Proportion without anamnestic response following boosting.

Secondary ID(s)

G0000531

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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