Disposable-Syringe Jet Injector for Measles-Mumps-Rubella vaccine (DSJI MMR) study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04280032

Enrollment

582

Registered

2010-07-29

Start date

2010-07-26

Completion date

Unknown

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, mumps and rubella vaccination Infections and Infestations Measles, mumps and rubella

Interventions

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 dev

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Parents/guardians unable or unwilling to give consent for the study 2. Unable to follow the study procedures

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Local and systemic adverse events during 42 days after vaccination	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026