Disposable-Syringe Jet Injector for Measles-Mumps-Rubella vaccine (DSJI MMR) study
| ISRCTN | ISRCTN04280032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04280032 |
| Protocol serial number | Asclin/002/2009 |
| Sponsor | Bio-Manguinhos/Fiocruz (Brazil) |
| Funders | Bill and Melinda Gates Foundation (USA) - PATH DSJI project, Bio-Manguinhos/Fiocruz (Brazil) |
- Submission date
- 08/07/2010
- Registration date
- 29/07/2010
- Last edited
- 10/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reinaldo Martins
Scientific
Scientific
Av. Brasil 4365
Manguinhos
Rio de janeiro
21040-360
Brazil
| Phone | +55 21 3882 9497 |
|---|---|
| rmenezes@bio.fiocruz.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled non-inferiority study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | DSJI/MMR |
| Study objectives | Immunogenicity of measles-mumps-rubella (MMR) vaccine administered by needle free device is non inferior to that induced by needle and syringe. |
| Ethics approval(s) | Approved on 4th April 2010 by: 1. PATH REC (ref: 499) 2. Brazilian CONEP National Ethics Committee (ref: 15810) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Measles-mumps-rubella vaccine |
| Primary outcome measure(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. |
| Key secondary outcome measure(s) |
Local and systemic adverse events during 42 days after vaccination |
| Completion date | 26/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 18 Months |
| Sex | All |
| Target sample size at registration | 582 |
| Total final enrolment | 582 |
| Key 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 |
| Key exclusion criteria | 1. Parents/guardians unable or unwilling to give consent for the study 2. Unable to follow the study procedures |
| Date of first enrolment | 26/07/2010 |
| Date of final enrolment | 26/07/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Brasil 4365
Rio de janeiro
21040-360
Brazil
21040-360
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | 10/07/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2019: Publication reference and total final enrolment added.
