Measles, mumps and rubella vaccine given to 14 month old children, administered subcutaneously versus intramuscularly

Completed

• Conditions: Measles Mumps Rubella (MMR) vaccination; Infections and Infestations; MMR vaccination

• Registration Number: ISRCTN61378987
• Lead Sponsor: ational Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 67

Inclusion Criteria

1. Children aged 12 to 18 months
2. 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded).

Secondary Outcome Measures

Name	Time	Method
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).