Status:
COMPLETED
Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Collaborating Sponsors:
PATH
Conditions:
Immune Response to MMR Vaccine
Eligibility:
All Genders
15-18 years
Phase:
PHASE4
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT02253407
Start Date
September 1 2014
End Date
February 1 2016
Last Update
March 14 2018
Active Locations (6)
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1
Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
Visakhapatnam, Andhra Pradesh, India, 530002
2
Krishna Institute of Medical Sciences Deemed University,
Karad, Maharashtra, India, 415110
3
Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
Pune, Maharashtra, India, 412216
4
Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, India, 411011