None listed
Conditions
Interventions
Intervention1: Needle Free Injection System: participants will be randomly
assigned to any vaccine via Needle Free Injection System at the time of Randomization and total study duration will be 10 day
Sponsors
IntegriMedical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infants boys or girls aged 6 months to 24 months will be included 2. Born at full-term pregnancy (greater or equal to 37 weeks) with a birth weight greater or equal to 2.5 kg and preterm pregnancy with a birth weight greater or equal to 2.0 kg 3. Infant with good general health as determined by the medical history physical examination and clinical judgment of the investigator 4. Informed Consent or Assent Form signed by the parent(s)legal guardian or any other Legally Acceptable Representative 5. Subject and parent or legally acceptable representative can attend all scheduled visits and comply with all trial procedures 6. 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 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 convulsions, epilepsy, other central nervous system diseases a severe disease of the haematopoietic system, decompensated heart disease or impaired renal function 4. Any other parenteral vaccine administration within 30 days of initiation of the study or during the study 5. A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy) 6. Subjects who have received blood blood products or immunoglobulins during the preceding 3 months 7. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination 8. Subjects with an acute febrile illness at the time of Enrollment or randomization 9. Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy such as anticancer chemotherapy or radiation therapy since birth or longterm systemic corticosteroid therapy prednisone or equivalent for more than 2 consecutive weeks since birth 10. Known personal or maternal history of Human Immunodeficiency Virus HIV or hepatitis C seropositivity 11. Known systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine containing the same substances 12. Known thrombocytopenia as reported by the parent or legally acceptable representative 13. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating subcutaneous vaccination 14. In an emergency setting or hospitalized involuntarily 15. Chronic illness that in the opinion of the investigator is at a stage where it might interfere with trial conduct or completion 16. 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 17. History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting 1 Pain 2 Redness 3 Swelling and tenderness around the injection site administered by NFIS 4 Post-immunization unsettledness or sleepiness in infants 2 To evaluate the VAS scoreTimepoint: 1.At 30 mins of Post Vaccination 2.Day 2 of Post Vaccination 3 Day 10 of post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To observe any other adverse events AEs and Serious Adverse Events (SAEs) post administration of Vaccine by the NFIS system which may or may not be related to NFIS Investigator Judgement on response rate by using the NFIS systemTimepoint: 1 30 minutes postvaccination 2 Day 2 postvaccination 3 Day 10 post vaccination | — |
Countries
India
Contacts
Public ContactMs Pranjal Ausekar
Ardent Clinical Research Services
Outcome results
None listed