None listed
Conditions
Interventions
Intervention1: MMR vaccine of Serum Institute of India Ltd to be administered by Disposable-Syringe Jet
Injector - Stratis: Single dose of 0.5 ml s.c. on anterolateral aspect of thigh to be administer
Sponsors
Serum Institute of India Ltd
Eligibility
Inclusion 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. 5)The participant should be the resident of study area.
Exclusion criteria
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 such as systemic corticosteroids 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)Infant who receive blood or bloodâ??derived products in the past. 6)Clinical history of measles, mumps, or rubella infection. 7)Previous history of MMR/MR combination vaccine or Rubella vaccine immunization. 8)Known history of a bleeding disorder or any condition that may be associated with prolonged bleeding time. 9)History of egg allergy to eggs, neomycin or gelatin. 10)An acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) within the past 21 days. 11)Infants with leukemia, lymphoma, or any other cancer or neoplasm. 12)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 13)History of febrile illness at the time of vaccination is a temporary exclusion criterion. 14)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seropositivity of individual infant for the diseases measles, mumps and rubellaTimepoint: 35 days after administration of the vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparrison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodiesTimepoint: Day 35;serious adverse events(SAEs)Timepoint: Day 35;Solicited adverse reactionsTimepoint: Day 14;Unsolicited adverse eventsTimepoint: Day 35 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd.
Outcome results
None listed