None listed
Conditions
Interventions
Intervention1: IntegriMedical Needle-Free Injection System (IM-N-FIS) with a single subcutaneous 0.5 mL dose of MMR vaccine: Participants who meet the eligibility criteria will be randomized either to
Sponsors
Mr Sarvesh Mutha
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be enrolled in the study if they meet all the following criteria: 1. Children of age 9-12 months at the time of the screening and have not received their first dose of MMR vaccine or individual antigens 2. Parents or legal guardians of participants willing to give written informed consent and willing to comply with study protocol 3. Free of any health problems as established by medical history and screening evaluation including clinical examination
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Children with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy. 2. Children with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances. 3. Children with history of epilepsy or a seizure disorder or neurodevelopmental disorders. 4. Clinical history of measles, mumps, or rubella infection. 5. History of allergy to eggs, milk, neomycin or gelatin 6. Children with leukemia, lymphoma, or any other cancer or neoplasm. 7. Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature 37.5 C. 8. 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 9. Children with any other condition, which, in the opinion of the investigator, would jeopardize the safety or rights of the children participating in the study or making it unlikely the participant could complete the protocol 10. History of encephalopathy or severe neurological disorders temporally associated with prior vaccination 11. Children participating in other clinical trials or planned participation in another clinical trial during the present trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and reactogenicity of a single dose of MMR vaccine administered using the IntegriMedical Needle-Free Injection System or conventional hypodermic needle injection in healthy children aged 9-12 monthsTimepoint: Incidence of immediate adverse events 30 minutes after each vaccination. Incidence, severity, and relationship of local and systemic solicited adverse events during 14-day follow-up period after each vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the immunogenicity of MMR vaccine administered using the IntegriMedical Needle-Free Injection System or conventional hypodermic needle injection in healthy children aged 9 12 months. Timepoint: Percentage of participants with seropositivity against measles, mumps & rubella antigens after receiving MMR vaccine either with IM-N-FIS or CHN, on Day 42 of vaccination Geometric Mean titers (GMTs) for anti-measles, anti-mumps & anti-rubella antibodies, on Day 42 of vaccination among subjects receiving MMR vaccine either with IM-N-FIS or CHN Fold rise in antibody levels, from baseline to Day 42 of vaccination among subjects receiving MMR vaccine either with IM-N-FIS or CHN | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
IntegriMedical Private Limited
Outcome results
None listed