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

Serum Institute of India

Status and phase: Completed; Phase 4

Conditions: Immune Response to MMR Vaccine

Treatments: Biological: MMR vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02253407

CTRI/2013/05/003702 (Registry Identifier)

MMR-01/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 15 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

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.
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. Clinical history of measles, mumps, or rubella infection.
6. Infants with leukemia, lymphoma, or any other cancer or neoplasm.
7. 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
8. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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341 participants in 2 patient groups

Disposable syringe jet injector

Experimental group

Description:

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.

Treatment:

Biological: MMR vaccine

Needle-Syringe

Active Comparator group

Description:

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

Treatment:

Biological: MMR vaccine