Immune Response to MMR Vaccine
Conditions
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 total 340 Indian infants aged 15 to 18 months.
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 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.
Interventions
BIOLOGICALMMR vaccine
Sponsors
PATH
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Months to 18 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity of individual child for measles, mumps and rubella | 35 days after administration of the study vaccines | Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature. |
Secondary
| Measure | 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 |
Countries
India
Outcome results
None listed