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
| ISRCTN | ISRCTN71271385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71271385 |
| Secondary identifying numbers | G0000531 |
- Submission date
- 21/09/2000
- Registration date
- 21/09/2000
- Last edited
- 02/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew J Hall
Scientific
Scientific
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GHABS |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Added as of 23/04/2007: 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 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
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/08/2007 | Yes | No |
