Health Condition 1: A35- Other tetanus
Conditions
Interventions
Intervention1: Needle Free Injection System (IM-NFIS)
: DTP vaccine.
The first in human assessment of IM-NFIS compared safety, tolerability and
acceptability of needle free injection system in 30 heal
Sponsors
IntegriMedical
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study performance of needle free injection system in healthy children of age group = 5 to = 6 years Timepoint: To study performance of needle free injection system in healthy children of age group = 5 to = 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean antibody titers (GMT) Time frame of 28 days after administration of dose To understand the acceptability & tolerability of needle free injection system in healthy children of age group = 5 to = 6 years Timepoint: Injection site reactions as assessed according to the toxicity scale provided by US FDA guidance with grading 0-4 Incidence of Adverse effects Acceptability questionnaire Pain score using VAS scale | — |
Countries
India
Contacts
Public ContactDr Aquil Faruqui
JCDC-CRO (Jehangir Clinical Development Centre) www.jcdc.co.in
Outcome results
None listed