| - candidate number | 2534 |
| - NTR Number | NTR943 |
| - ISRCTN | ISRCTN61378987 |
| - Date ISRCTN created | 2-mei-2007 |
| - date ISRCTN requested | 20-apr-2007 |
| - Date Registered NTR | 2-apr-2007 |
| - Secondary IDs | LTR086a |
| - Public Title | MMR vaccine given to 14 month old children, administered subcutaneously versus intramuscularly. |
| - Scientific Title | MMR vaccine given to 14 month old children, administered subcutaneously versus intramuscularly. |
| - ACRONYM | N/A |
| - hypothesis | MMR vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously. |
| - Healt Condition(s) or Problem(s) studied | Infectious diseases, Measles, Mumps, Rubella |
| - Inclusion criteria | 1. Children aged 12 to 18 months in good general health. |
| - Exclusion criteria | 1. Proven allergy for any of the vaccine components; 2. Contraindication for MMR vaccination (e.g. administration of blood products within 3 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. laguage issues; 6. Previous MMR vaccination; 7. Administration of another vaccine simultaneous to the MMR vaccination. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | no |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-feb-1998 |
| - planned closingdate | 1-sep-2001 |
| - Target number of participants | 67 |
| - Interventions | 2 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). |
| - Primary outcome | The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded). |
| - Secondary outcome | The immunogenicity of the MMR vaccine administered subcutaneously versus intramuscularly as measured by the antibody titers before and 12 weeks after vaccination. Antibody titers are determined by a twofold serial dilution ELISA. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | PhD G. Berbers |
| - CONTACT for SCIENTIFIC QUERIES | PhD G. Berbers |
| - Sponsor/Initiator | National Institute for Public Health and the Environment (RIVM) |
| - Funding (Source(s) of Monetary or Material Support) | The Netherlands Healthcare Inspectorate |
| - Publications | AB Lafeber et al. RIVM report 000002 001, sep. 2001 |
| - Brief summary | In this study we compared the recommended subcutaneous administration of the RIVM MMR vaccine with the intramuscular administration for both safety and immunogenicity. Pain immediately after vaccination was the most reported adverse reaction. Serious pain was more often reported after subcutaneous vaccination. However, because of the low number of participants in this study, pain serves only as an indication since statistical backing is lacking. Both subcutaneous and intramuscular administered MMR vaccine induced a good immune response. In conclusion, inadvertent intramuscular administration of MMR vaccine is not enough reason for revaccination. |
| - Main changes (audit trail) | |
| - RECORD | 2-apr-2007 - 20-mei-2008 |
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