Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
- Conditions
- Immune Response to MMR Vaccine
- Interventions
- Biological: MMR vaccine
- Registration Number
- NCT02253407
- Lead Sponsor
- Serum Institute of India Pvt. Ltd.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 341
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Disposable syringe jet injector MMR vaccine 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. Needle-Syringe MMR vaccine 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
- Primary Outcome Measures
Name Time Method Seropositivity of individual child for measles, mumps and rubella 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
Name Time Method Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies Day 35 Serious adverse events (SAEs) Day 35 Solicited adverse reactions Day 14 Unsolicited adverse events Day 35
Trial Locations
- Locations (6)
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
🇮🇳Pune, Maharasthra, India
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
🇮🇳Chennai, Tamil Nadu, India
Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
🇮🇳Pune, Maharashtr, India
Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
🇮🇳Visakhapatnam, Andhra Pradesh, India
Krishna Institute of Medical Sciences Deemed University,
🇮🇳Karad, Maharashtra, India
Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
🇮🇳Pune, Maharashtra, India