Contact information
Type
Scientific
Primary contact
Dr Reinaldo Martins
ORCID ID
Contact details
Av. Brasil 4365
Manguinhos
Rio de janeiro
21040-360
Brazil
+55 21 3882 9497
rmenezes@bio.fiocruz.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Asclin/002/2009
Study information
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
Acronym
DSJI/MMR
Study hypothesis
Immunogenicity of measles-mumps-rubella (MMR) vaccine administered by needle free device is non inferior to that induced by needle and syringe.
Ethics approval
Approved on 4th April 2010 by:
1. PATH REC (ref: 499)
2. Brazilian CONEP National Ethics Committee (ref: 15810)
Study design
Randomised controlled non-inferiority study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Measles, mumps and rubella vaccination
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Measles-mumps-rubella vaccine
Primary outcome measures
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 measures
Local and systemic adverse events during 42 days after vaccination
Overall trial start date
26/07/2010
Overall trial end date
26/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
582 children
Participant exclusion criteria
1. Parents/guardians unable or unwilling to give consent for the study
2. Unable to follow the study procedures
Recruitment start date
26/07/2010
Recruitment end date
26/07/2011
Locations
Countries of recruitment
Brazil
Trial participating centre
Av. Brasil 4365
Rio de janeiro
21040-360
Brazil
Sponsor information
Organisation
Bio-Manguinhos/Fiocruz (Brazil)
Sponsor details
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-360
Brazil
+55 21 3882 9305
artur@bio.fiocruz.br
Sponsor type
Industry
Website
Funders
Funder type
Charity
Funder name
Bill and Melinda Gates Foundation (USA) - PATH DSJI project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bio-Manguinhos/Fiocruz (Brazil)
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