None listed
Conditions
Interventions
Intervention1: Needle Free Injection System (N-FISTM): Participants will receive the vaccine (Various types of vaccine irrespective of the
brand) through the Needle Free Injection System (N-FISTM) for
Sponsors
IntegriMedical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy infants boys or girls aged less than 6 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 pre-term 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 (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR) 5 Subject and parent/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 [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 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 signi ??icant concurrent illness affecting immune response after vaccination 8 Subjects with an acute febrile illness at the time of enrolment/randomization 9. 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) 10 Known personal or maternal history of Human Immunode ??iciency Virus (HIV) or hepatitis C seropositivity 11 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 12 Known thrombocytopenia, as reported by the parent/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 (N-FISTM) in terms of the number of participants reporting a) Pain b) Redness c) Swelling and tenderness around the injection site administered by N-FISTM d) Post immunization unsettledness or sleepiness in infants 2 To evaluate the NIPS score at 30 mins of VaccinationTimepoint: 1 At 30 minutes of post-vaccination 2 Day 2 post vaccination 3 Day 10 post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To observe any other adverse events and Serious Adverse Events post administration of Vaccine by the N-FISTM system which may or may not be related to N-FISTM. 2 Investigator Judgement on response rate by using the N-FISTM systemTimepoint: 1 At 30 minutes of post-vaccination. 2 Day 2 post vaccination 3 Day 10 post vaccination | — |
Countries
India
Contacts
Public ContactMrsPranjal Ausekar
Ardent Clinical Research Services
Outcome results
None listed