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 |
| Protocol serial number | G0000531 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Added as of 23/04/2007: |
| Key secondary outcome measure(s) |
Added as of 23/04/2007: |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Gambia
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
