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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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29 July 2019 |
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Main ID: |
ISRCTN04280032 |
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Date of registration:
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29/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Disposable-Syringe Jet Injector for Measles-Mumps-Rubella vaccine (DSJI MMR) study
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Scientific title:
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A randomised, non-inferiority study comparing safety and immunogenicity of a disposable-syringe jet injector to needle and syringe for the administration of measles-mumps-rubella combination vaccine to healthy Brazilian infants aged 12 to 18 months |
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Date of first enrolment:
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26/07/2010 |
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Target sample size:
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582 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN04280032 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled non-inferiority study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Reinaldo
Martins |
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Address:
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Av. Brasil 4365
Manguinhos
21040-360
Rio de janeiro
Brazil |
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Telephone:
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+55 21 3882 9497 |
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Email:
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rmenezes@bio.fiocruz.br |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Healthy children from 12 to 18 months of age, either sex
2. Up-to-date with their immunisation schedule according to age
3. Not enrolled in other clinical studies
Exclusion criteria:
1. Parents/guardians unable or unwilling to give consent for the study
2. Unable to follow the study procedures
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Measles, mumps and rubella vaccination
Infections and Infestations
Measles, mumps and rubella
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Intervention(s)
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MMR vaccine, against measles, mumps and rubella (Schwarz, RIT 4385 and Wistar RA 27/3 strains, respectively), to be administered as a single 0.5 mL dose, subcutaneously, delivered by a needle-free device (experimental group) or by the conventional needle and syringe method (control group), in a 2:1 proportion,
that is, 388 volunteers allocated to the experimental group and 194 to the control group. Volunteers will be followed-up for 42 days after vaccination. Blood collections for immunogenicity before vaccination and 42 days after vaccination. Adverse events will be registered in diary cards by parents/guardians during this period.
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Primary Outcome(s)
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Antibody titres 42 days after vaccination: cut offs for enzyme-linked immunosorbent assay (ELISA) 231 units/mL (mumps) and 4 IU/mL for rubella. Plaque reduction neutralisation test (PRNT) for measles, cut off 0.20 IU/mL.
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Secondary Outcome(s)
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Local and systemic adverse events during 42 days after vaccination
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Secondary ID(s)
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Asclin/002/2009
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Source(s) of Monetary Support
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Bill and Melinda Gates Foundation (USA) - PATH DSJI project, Bio-Manguinhos/Fiocruz (Brazil)
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Ethics review
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Status:
Approval date:
Contact:
Approved on 4th April 2010 by:
1. PATH REC (ref: 499)
2. Brazilian CONEP National Ethics Committee (ref: 15810)
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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26/07/2011 |
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URL:
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