None listed
Conditions
Interventions
Intervention1: Needle free injection system: Participants will be randomly assigned to Needle free Injection System(NFIS) arm to receive single dose of tresivac MMR vaccine.
Control Intervention1: Tra
Sponsors
IntegriMedical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy Infant(s) of 9 months to 12 months of age on the day of inclusion 2 Born at full term pregnancy (greater or equal to 37 weeks) with a birth weight greater or equal to 2.5 kg and pre-term pregnancy with a birth weight greater or equal to 2.0 kg 3 Informed Consent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR) 4 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures 5 Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg)
Exclusion criteria
Exclusion criteria: 1 Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine drug medical device or medical procedure 2 Any vaccination administered within four weeks before the initial trial vaccination (excluding the Bacillus Calmette-Guerin [BCG] vaccine) or any vaccination expected to be administered within eight days before and eight days after each subsequent trial vaccination. 3 Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement. 4 Subjects having received measles vaccine less than 3 months back. 5 Subjects with a history of convulsions epilepsy other central nervous system diseases severe disease of haematopoietic system decompensated heart disease or impaired renal function 6 Any other parenteral vaccine administration within 30 days of initiation of the study or during the study 7 A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy) 8 Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months 9 Subjects with any other clinically significant concurrent illness affecting immune response after vaccination 10 Subjects with an acute febrile illness at the time of enrollment/randomization 11 Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) 12 Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity 13 Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances 14 Known thrombocytopenia as reported by the parent/legally acceptable representative 15 Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination 16 In an emergency setting or hospitalized involuntarily 17 Chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion 18 Identified as a natural or adopted child of the Investigator relatives or employee with direct involvement in the proposed study (To avoid conflict of interest in the study) 19 History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate the Safety of Needle Free Injection System (NFIS) (Note- safety in terms of Pain redness swelling itching observed at the injection site and any other adverse events or serious adverse events due to NFIS) 2)To evaluate the number of participants reporting solicited injection site reactions solicited &/or unsolicited systemic reactions after administration of Tresivac MMR vaccineTimepoint: (Pre vaccination) Day 1 to Day 28 (post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Evaluate the levels of antibodies concentration to the vaccine antigens following single dose of Tresivac MMR vaccineTimepoint: (Pre vaccination) Day 1 to Day 28 (post-vaccination | — |
Countries
India
Contacts
Public ContactMs Pranjal Ausekar
Ardent Clinical Research Services
Outcome results
None listed