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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase IV, Non-Inferiority, Observer Blind Randomized Clinical Study Comparing Safety And Immunogenicity Of MMR Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months

Conditions
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Immune Response to MMR Vaccine

Intervention / Treatment
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* Biological: MMR vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disposable syringe jet injector<br>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<br> <br> * Other names: Tresivac;|
| Active Comparator: Needle-Syringe<br>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<br> <br> * Other names: Tresivac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |