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ISRCTN
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ISRCTN04280032
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ClinicalTrials.gov identifier
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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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Acronym
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DSJI/MMR
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Serial number at source
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Asclin/002/2009
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Study hypothesis
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Immunogenicity of measles-mumps-rubella (MMR) vaccine administered by needle free device is non inferior to that induced by needle and syringe.
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Lay summary
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Ethics approval
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Approved on 4th April 2010 by:
1. PATH REC (ref: 499)
2. Brazilian CONEP National Ethics Committee (ref: 15810)
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Study design
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Randomised controlled non-inferiority study
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Measles, mumps and rubella vaccination
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Parents/guardians unable or unwilling to give consent for the study
2. Unable to follow the study procedures
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Anticipated start date
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26/07/2010
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Anticipated end date
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26/07/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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582 children
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Interventions
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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 measure(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 measure(s)
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Local and systemic adverse events during 42 days after vaccination
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Sources of funding
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1. Bill and Melinda Gates Foundation (USA) - PATH DSJI project
2. Bio-Manguinhos/Fiocruz (Brazil)
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Trial website
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Publications
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Contact name
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Dr
Reinaldo
Martins
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Address
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Av. Brasil 4365
Manguinhos
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City/town
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Rio de janeiro
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Zip/Postcode
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21040-360
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Country
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Brazil
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Tel
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+55 21 3882 9497
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Fax
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+55 21 3882 7176
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Email
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rmenezes@bio.fiocruz.br
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Sponsor
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Bio-Manguinhos/Fiocruz (Brazil)
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Address
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Av. Brasil 4365
Manguinhos
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City/town
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Rio de Janeiro
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Zip/Postcode
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21040-360
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Country
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Brazil
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Tel
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+55 21 3882 9305
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Fax
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+55 21 3882 7176
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Email
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artur@bio.fiocruz.br
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Sponsor website:
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http://www.bio.fiocruz.br
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Date applied
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08/07/2010
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Last edited
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12/07/2010
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Date ISRCTN assigned
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29/07/2010
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