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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR943 |
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Date of registration:
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02/04/2007 |
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Primary sponsor: |
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Public title:
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MMR vaccine given to 14 month old children, administered subcutaneously versus intramuscularly.
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Scientific title:
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MMR vaccine given to 14 month old children, administered subcutaneously versus intramuscularly. - N/A |
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Date of first enrolment:
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1/2/1998 |
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Target sample size:
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67 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=943 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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G.
Berbers |
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Address:
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RIVM, afd. LIS
Postbus 1
3720 BA
Bilthoven
The Netherlands |
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Telephone:
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+31 30-2742496 |
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Email:
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guy.berbers@rivm.nl |
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Affiliation:
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Name:
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G.
Berbers |
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Address:
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RIVM, afd. LIS
Postbus 1
3720 BA
Bilthoven
The Netherlands |
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Telephone:
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+31 30-2742496 |
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Email:
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guy.berbers@rivm.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Infectious diseases, Measles, Mumps, Rubella
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Intervention(s)
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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).
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Primary Outcome(s)
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The occurrence of adverse events after the MMR vaccine administered subcutaneously versus intramuscularly as recorded by the parents (non-blinded).
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN61378987
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LTR086a
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Source(s) of Monetary Support
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The Netherlands Healthcare Inspectorate
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