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Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children

NCT02253407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2018-03-14

No results posted yet for this study

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.

Conditions

  • Immune Response to MMR Vaccine

Interventions

BIOLOGICAL

MMR vaccine

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ashish Bavdekar, MD · Department of Pediatrics, KEM Hospital Research Centre, Pune, India

  • Jitendra Oswal, MD · Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02253407 on ClinicalTrials.gov