Trials / Completed
CompletedNCT02253407
Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
A Phase IV, Non-Inferiority, Observer Blind Randomized Clinical Study Comparing Safety And Immunogenicity Of MMR Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 341 (actual)
- Sponsor
- Serum Institute of India Pvt. Ltd. · Industry
- Sex
- All
- Age
- 15 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
This is a study planned to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.
Detailed description
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MMR vaccine |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2014-10-01
- Last updated
- 2018-03-14
Locations
6 sites across 1 country: India
Source: ClinicalTrials.gov record NCT02253407. Inclusion in this directory is not an endorsement.