Condition category
Infections and Infestations
Date applied
08/07/2010
Date assigned
29/07/2010
Last edited
12/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bio.fiocruz.br

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

Publication citations

Additional files

Editorial Notes