eedle Free Injection System (NFIS) is a study for giving booster Diphtheria-Tetanus-Pertussis (DTP) vaccine using needle free injections.
- Conditions
- Health Condition 1: A35- Other tetanus
- Registration Number
- CTRI/2023/10/058954
- Lead Sponsor
- IntegriMedical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Patients meeting following inclusion criteria will be eligible for participation in the study
1 Parents/ Legally Acceptable Representative (LAR) of the subject willing to sign the informed consent form
2 Eligible and due for booster dose of DTP vaccine
3 Physical examination without clinically significant findings
4 No history of liver disorders in past 3 months
5 No history of kidney disorders in past 3 months
6 No history of cardiovascular disorders in past 3 months
7 No history of neurological disorders in past 3 months
8 In good general health without clinically significant medical history and based on clinical judgment of principal investigator
Subjects are excluded from the study if any of the following criteria apply
Medical Conditions and Prior medication
1 Are malnourished, defined by weight less than two standard deviations below the median weight for their age
2 More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
3 Blood products within 16 weeks prior to enrollment
4 Evidence of autoimmune disease or immunodeficiency
5 Asthma that is not well controlled
6 Idiopathic urticaria within the past year
7 Hypertension that is not well controlled
8 Malignancy that is active or history of malignancy
9 Have a genetic anomaly or known cytogenic disorder (e.g., Down syndrome)
10 Bleeding disorder history (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM, SC injection or blood draws
11 Diabetes mellitus (type I )
12 Any medical, psychiatric, social condition, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteers ability to give informed consent
13 Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid- tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX
14 Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine
15 Progressive neurologic disorders
16 If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid
17 Syncope (fainting) occurred anytime in association with administration of injectable vaccines, including INFANRIX
18 If temperature =105°F, collapse or shock-like state, or persistent, inconsolable crying lasting =3 hours have occurred within 48 hours after receipt of a previous pertussis- containing vaccine, or if seizures have occurred within 3 days after receipt of a previous pertussis-containing vaccine
Prior/Concurrent Clinical Study Experience
19 Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>To study performance of needle free injection system in healthy children of age group = 5 to = 6 years <br/ ><br>Timepoint: <br/ ><br>To study performance of needle free injection system in healthy children of age group = 5 to = 6 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method Geometric mean antibody titers <br/ ><br>(GMT) Time frame of 28 days after administration of dose <br/ ><br> <br/ ><br>To understand the acceptability & tolerability of needle free injection system in healthy children of age group = 5 to = 6 years <br/ ><br>Timepoint: Injection site reactions as assessed <br/ ><br>according to the toxicity scale provided by US FDA guidance with grading 0-4 <br/ ><br> <br/ ><br>Incidence of Adverse effects <br/ ><br> <br/ ><br>Acceptability questionnaire <br/ ><br> <br/ ><br>Pain score using VAS scale <br/ ><br> <br/ ><br>