A post marketing surveillance study to evaluate the safety of Needle Free Injection System (N-FISTM) when administered with various types of vaccine for healthy infants aged 6 months to 24 months

IntegriMedical Private Limited3 sites in 1 country500 target enrollmentStarted: September 28, 2024Last updated: September 24, 2024

Overview

Phase: Post Marketing Surveillance
Status: Recruiting
Sponsor: IntegriMedical Private Limited
Enrollment: 500
Locations: 3
Primary Endpoint: 1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

Itâ€™s a single-arm, non-randomized, multicenter post-marketing surveillance study aimed

at generating safety data for evaluating the Needle-Free Injection System (N-FISTM) when

used with vaccines.

Safety will be assessed based on injection site reactions, Adverse Events (AEs), and

Serious Adverse Events (SAEs) experienced by trial participants at three time points:

within the first 30mins (at the hospital), Day-2 (Telephonic Follow Up) and Day-10

(Telephonic Follow up).

Study Design

Study Type: Pms
Allocation: Na
Masking: None

Eligibility Criteria

Ages: 6.00 Month(s) to 24.00 Month(s) (—)
Sex: All

Inclusion Criteria

•Healthy infants boys or girls aged 6 months to 24 months will be included
•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
•Infant with good general health as determined by the medical history physical examination and clinical judgment of the investigator
•Informed Consent or Assent Form signed by the parent(s)legal guardian or any other Legally Acceptable Representative
•Subject and parent or legally acceptable representative can attend all scheduled visits and comply with all trial procedures
•Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg).

Exclusion Criteria

•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
•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
•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
•Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
•A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy)
•Subjects who have received blood blood products or immunoglobulins during the preceding 3 months
•Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
•Subjects with an acute febrile illness at the time of Enrollment or randomization
•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
•Known personal or maternal history of Human Immunodeficiency Virus HIV or hepatitis C seropositivity

Outcomes

Primary Outcomes

1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting