MMR vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.
ID
Bron
Verkorte titel
Aandoening
Infectious Diseases, Measles, Mumps, Rubella.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
MMR vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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).
Publiek
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Wetenschappelijk
Postbus 1
G. Berbers
Bilthoven 3720 BA
The Netherlands
+31 30-2742496
guy.berbers@rivm.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Children aged 12 to 18 months in good general health.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL919 |
| NTR-old | NTR943 |
| Ander register | : LTR086a |
| ISRCTN | ISRCTN61378987 |