No registrations found.
ID
Source
Brief title
Health condition
Infectious Diseases, Measles, Mumps, Rubella.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
MMR vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.
Study design
N/A
Intervention
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).
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL919 |
| NTR-old | NTR943 |
| Other | : LTR086a |
| ISRCTN | ISRCTN61378987 |