Measles, mumps and rubella vaccine given to 14 month old children, administered subcutaneously versus intramuscularly
| ISRCTN | ISRCTN61378987 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61378987 |
| Protocol serial number | LTR086a |
| Sponsor | National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands) |
| Funder | The Netherlands Healthcare Inspectorate (The Netherlands) |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 29/07/2008
- 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 G. Berbers
Scientific
Scientific
National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands
| Phone | +31 (0)30 274 2496 |
|---|---|
| guy.berbers@rivm.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, interventional, parallel group trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study objectives | Measles, Mumps and Rubella (MMR) vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously. |
| Ethics approval(s) | Approval received from the TNO Preventie en Gezondheid (this committee ceased to exist as of 01-Jan-2004) on the 20th January 1999 (ref: METC 98/61). |
| Health condition(s) or problem(s) studied | Measles Mumps Rubella (MMR) vaccination |
| Intervention | Two groups of children aged 14 months: 1. MMR vaccine (RVG number 17654) given subcutaneously (n = 34) 2. MMR vaccine (RVG number 17654) given intramuscularly (n = 34) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Measles, Mumps and Rubella (MMR) vaccine |
| Primary outcome measure(s) |
The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded). |
| Key secondary outcome measure(s) |
The immunogenicity of the MMR vaccine administered subcutaneously versus intramuscularly as measured by the antibody titres before and 12 weeks after vaccination. Antibody titres are determined by a twofold serial dilution Enzyme Linked Immunosorbert Assay (ELISA). |
| Completion date | 01/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 18 Months |
| Sex | Not Specified |
| Target sample size at registration | 67 |
| Key inclusion criteria | 1. Children aged 12 to 18 months 2. In good general health |
| Key exclusion criteria | 1. Proven allergy for any of the vaccine components 2. Contraindication for MMR vaccination (e.g. administration of blood products within three months before MMR vaccination) 3. Known immune disorder 4. Coagulation disorder (not being able to receive intramuscular injection) 5. Parents/legal representatives who cannot participate optimally in the trial due to, e.g., language issues 6. Previous MMR vaccination 7. Administration of another vaccine simultaneous to the MMR vaccination |
| Date of first enrolment | 01/02/1998 |
| Date of final enrolment | 01/09/2001 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
National Institute for Public Health and the Environment (RIVM)
Bilthoven
3720 BA
Netherlands
3720 BA
Netherlands
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 | 26/10/2001 | Yes | No |
