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

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ClinicalTrials.gov Identifier: NCT02253407
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Immune Response to MMR Vaccine Biological: MMR vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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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 Name: 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 Name: Tresivac


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies [ Time Frame: Day 35 ]
  2. Solicited adverse reactions [ Time Frame: Day 14 ]
  3. Unsolicited adverse events [ Time Frame: Day 35 ]
  4. Serious adverse events (SAEs) [ Time Frame: Day 35 ]

Eligibility Criteria
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Ages Eligible for Study:   15 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253407


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

Publications of Results:

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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02253407    
Other Study ID Numbers: MMR-01/12
CTRI/2013/05/003702 ( Registry Identifier: Clinical Trial Registry of India )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018