Contact information
Type
Scientific
Primary contact
Dr G. Berbers
ORCID ID
Contact details
National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 2496
guy.berbers@rivm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LTR086a
Study information
Scientific title
Acronym
Study hypothesis
Measles, Mumps and Rubella (MMR) vaccine administered intramuscularly induces the same adverse effects and immunogenicity as subcutaneously.
Ethics approval
Approval received from the TNO Preventie en Gezondheid (this
committee ceased to exist as of 01-Jan-2004) on the 20th January 1999 (ref: METC 98/61).
Study design
Non-randomised, interventional, parallel group trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Measles Mumps Rubella (MMR) vaccination
Intervention
Two 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)
Intervention type
Drug
Phase
Not Specified
Drug names
Measles, Mumps and Rubella (MMR) vaccine
Primary outcome measures
The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded).
Secondary outcome measures
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).
Overall trial start date
01/02/1998
Overall trial end date
01/09/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 12 to 18 months
2. In good general health
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
67
Participant 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
Recruitment start date
01/02/1998
Recruitment end date
01/09/2001
Locations
Countries of recruitment
Netherlands
Trial participating centre
National Institute for Public Health and the Environment (RIVM)
Bilthoven
3720 BA
Netherlands
Sponsor information
Organisation
National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
Sponsor details
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 9111
info@rivm.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Netherlands Healthcare Inspectorate (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.rivm.nl/bibliotheek/rapporten/000002001.html