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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.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN04280032
Date of registration: 29/07/2010
Primary sponsor: Bio-Manguinhos/Fiocruz (Brazil)
Public title: Disposable-Syringe Jet Injector for Measles-Mumps-Rubella vaccine (DSJI MMR) study DSJI/MMR
Scientific title: 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
Date of first enrolment: Jul 26 2010
Target sample size: 582 children
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN04280032
Study type:  Interventional
Study design:  Randomised controlled non-inferiority study  
Countries of recruitment
Brazil
Contacts
Name: Reinaldo  Martins
Address:  Av. Brasil 4365 Manguinhos 21040-360 Rio de janeiro Brazil
Telephone: +55 21 3882 9497
Email: rmenezes@bio.fiocruz.br
Affiliation: 
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Measles, mumps and rubella vaccination
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
Local and systemic adverse events during 42 days after vaccination
Secondary ID(s)
Asclin/002/2009
Source(s) of Monetary Support
1. Bill and Melinda Gates Foundation (USA) - PATH DSJI project 2. Bio-Manguinhos/Fiocruz (Brazil)
Secondary Sponsor(s)
N/A
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