Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G0000531
Study information
Scientific title
Acronym
GHABS
Study hypothesis
Added as of 23/04/2007:
A booster dose of Hepatitis B Virus (HBV) vaccine 15 years after infant vaccination will increase the magnitude and duration of immune responses (measured two and 52 weeks after the boost).
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Hepatitis B Virus
Intervention
Added as of 23/04/2007:
Booster dose HBV vaccine
Intervention type
Other
Primary outcome measure
Added as of 23/04/2007:
Anti-HBs titers after one year.
Secondary outcome measures
Added as of 23/04/2007:
Proportion without anamnestic response following boosting.
Overall study start date
01/01/2004
Overall study end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Child
Sex
Both
Target number of participants
Added as of 23/04/2007: 500
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
England, Gambia, United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/08/2007 | Yes | No |