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

March 13, 2018 updated by: Serum Institute of India Pvt. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
    • Maharashtr
      • Pune, Maharashtr, India, 411011
        • Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
    • Maharashtra
      • Karad, Maharashtra, India, 415110
        • Krishna Institute of Medical Sciences Deemed University,
      • Pune, Maharashtra, India, 412216
        • Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
    • Maharasthra
      • Pune, Maharasthra, India, 411043
        • Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600116
        • Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
  2. Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
  3. Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
  4. Free of obvious health problems as established by medical history and screening evaluation including clinical examination.

Exclusion Criteria:

  1. Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
  2. Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
  3. Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
  4. Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
  5. Clinical history of measles, mumps, or rubella infection.
  6. Infants with leukemia, lymphoma, or any other cancer or neoplasm.
  7. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
  8. Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disposable syringe jet injector
Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc.
Biological: MMR vaccine
Other Names:
  • Tresivac
Active Comparator: Needle-Syringe
Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via conventional needle and Syringe
Biological: MMR vaccine
Other Names:
  • Tresivac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seropositivity of individual child for measles, mumps and rubella
Time Frame: 35 days after administration of the study vaccines
Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.
35 days after administration of the study vaccines

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
Time Frame: Day 35
Day 35
Solicited adverse reactions
Time Frame: Day 14
Day 14
Unsolicited adverse events
Time Frame: Day 35
Day 35
Serious adverse events (SAEs)
Time Frame: Day 35
Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serum Institute of India Pvt. Ltd.

Collaborators

PATH

Investigators

  • Principal Investigator: Ashish Bavdekar, MD, Department of Pediatrics, KEM Hospital Research Centre, Pune, India
  • Principal Investigator: Jitendra Oswal, MD, Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

September 27, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MMR-01/12
  • CTRI/2013/05/003702 (Registry Identifier: Clinical Trial Registry of India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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