To evaluate the safety of Needle free injection and immunegenicity of Tresivac MMR vaccine in healthy infants

Not Applicable

• Registration Number: CTRI/2024/01/061633
• Lead Sponsor: IntegriMedical Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To evaluate the Safety of Needle Free Injection System (NFIS) <br/ ><br> <br/ ><br>(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) <br/ ><br>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 Outcome Measures

Name	Time	Method
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