A strategy to immunize young infants against measles
| ISRCTN | ISRCTN45483324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45483324 |
| Protocol serial number | SCC 948 |
| Sponsor | Medical Research Council (UK) |
| Funder | Medical Research Council (MRC) (SCC948)(UK) |
- Submission date
- 15/09/2005
- Registration date
- 03/11/2005
- Last edited
- 28/10/2021
- 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
Prof Hilton Whittle
Scientific
Scientific
MRC Laboratories
Fajara
PMB243
Gambia
| Phone | +220 4496715 |
|---|---|
| hwhittle@mrc.gm |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A strategy to immunize young infants against measles |
| Study objectives | Immunogenicity of Edmonston-Zagreb measles vaccine given at 4 and 9 months of age will be superior to that of the vaccine given at 9 months of age |
| Ethics approval(s) | Added as of 30/07/2007: This trial was approved by: 1. The Gambia Government / Medical Research Council Ethics Committee 2. The London School of Hygiene and Tropical Medicine |
| Health condition(s) or problem(s) studied | Measles |
| Intervention | Edmonston-Zagreb measles vaccine given at 4 and 9 months of age versus vaccine given at 9 months of age |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Edmonston-Zagreb measles vaccine |
| Primary outcome measure(s) |
Gamma interferon elispot counts after stimulation of peripheral blood mononuclear cells with measles virus at 18 months of age |
| Key secondary outcome measure(s) |
Measles haemagglutinin inhibiting antibody at 18 months of age |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 132 |
| Key inclusion criteria | Healthy children whose parents agree to the trial |
| Key exclusion criteria | Malnourished children or those with a febrile illness |
| Date of first enrolment | 02/07/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Gambia
Study participating centre
MRC Laboratories
Fajara
PMB243
Gambia
PMB243
Gambia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results at 3 year booster | 28/03/2012 | 28/10/2021 | Yes | No |
Editorial Notes
28/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
