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

NCT02253407 | Completed Phase 4

• 2 other identifiers: MMR-01/12CTRI/2013/05/003702
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 6

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.

Conditions

Immune Response to MMR Vaccine

Outcome Measures

Primary Outcomes (1)

• Seropositivity of individual child for measles, mumps and rubella

  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 Outcomes (4)

• Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies

  Day 35

• Solicited adverse reactions

  Day 14

• Unsolicited adverse events

  Day 35

• Serious adverse events (SAEs)

  Day 35

Study Arms (2)

Disposable syringe jet injector

EXPERIMENTAL

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

Needle-Syringe

ACTIVE COMPARATOR

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

Interventions

MMR vaccine BIOLOGICAL

Also known as: Tresivac

Disposable syringe jet injector; Needle-Syringe

Eligibility Criteria

• Age: 15 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
• Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
• Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
• Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
• Clinical history of measles, mumps, or rubella infection.
• Infants with leukemia, lymphoma, or any other cancer or neoplasm.
• 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
• 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.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead
• PATH: collaborator

Study Sites (6)

Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Krishna Institute of Medical Sciences Deemed University,

Karad, Maharashtra, 415110, India

Location

Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur

Pune, Maharashtra, 412216, India

Location

Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,

Pune, Maharashtr, 411011, India

Location

Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi

Pune, Maharasthra, 411043, India

Location

Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,

Chennai, Tamil Nadu, 600116, India

Location

Related Publications (1)

• Bavdekar A, Oswal J, Ramanan PV, Aundhkar C, Venugopal P, Kapse D, Miller T, McGray S, Zehrung D, Kulkarni PS; SII MMR author group. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial. Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1.

  PMID: 29395526 RESULT

MeSH Terms

Interventions

Measles-Mumps-Rubella Vaccine

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

IN (6)