Clinical Study to assess safety and immune response of MMR subcutaneous vaccination by Disposable Syringe Jet Injector as compared to Needle Syringe method in 15-18 month old children

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2013
INTERVENTION: 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 administered by Disposable‐Syringe Jet Injector ‐ Stratis at 15 to 18 months of age Control Intervention1: MMR vaccine of Serum Institute of India Ltd to be administered by Needle and Syringe: Single dose of 0.5 ml s.c. on anterolateral aspect of thigh to be administered by Needle and Syringe at 15 to 18 months of age CONDITION: Prevention of Measeles, Mumps and Rubella in infants aged 15 to 18 months by subcutaneous vaccination. PRIMARY OUTCOME: Seropositivity of individual infant for the diseases measles, mumps and rubella‐‐‐‐‐‐Timepoint: 35 days after administration of the vaccine SECONDARY OUTCOME: Comparrison of Geometric Mean titers (GMTs) for anti‐measles, anti‐mumps and anti‐rubella antibodies‐‐‐‐‐‐Timepoint: Day 35 serious adverse events(SAEs)‐‐‐‐‐‐Timepoint: Day 35 Solicited adverse reactions‐‐‐‐‐‐Timepoint: Day 14 Unsolicited adverse events‐‐‐‐‐‐Timepoint: Day 35 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.
Epistemonikos ID: df21755f859a6db1a22bf29cd6894ad32b2f4bb5
First added on: Aug 22, 2024