Infectious Diseases, Measles, Mumps, Rubella.
Conditions
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).
Sponsors
National Institute for Public Health and the Environment (RIVM)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 12 to 18 months in good general health.
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded). | — |
Contacts
Public ContactG. Berbers
RIVM, afd. LIS Postbus 1
Outcome results
None listed