| CTRI Number |
CTRI/2023/10/058954 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Needle Free Injection System (NFIS) is a study for giving booster Diphtheria-Tetanus-Pertussis (DTP) vaccine using needle free injections. |
|
Scientific Title of Study
|
An Open label, 1-arm study to investigate clinical safety, tolerability, acceptability and performance of IntegriMedical® Needle Free Injection System in administering booster Diphtheria-Tetanus-Pertussis (DTP) vaccine in healthy male and female pediatric subjects aged ≥5 to ≤6 years of age. |
| Trial Acronym |
NFIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IM/NFIS/02 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Neelambari Bhosale |
| Designation |
Head Clinical Operations |
| Affiliation |
JCDC-CRO (Jehangir Clinical Development Centre) www.jcdc.co.in |
| Address |
Jehangir Clinical Development Centre. Clinical Research Department, Jehangir
Hospital Premises
32 Sasoon Road
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
neelambari@jcdc.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Bafna |
| Designation |
Investigator |
| Affiliation |
JCDC-CRO (Jehangir Clinical Development Centre) www.jcdc.co.in |
| Address |
Clinical Research Department, Jehangir Clinical Development Centre Jehangir
Hospital Premises
32 Sasoon Road
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA
411001
India |
| Phone |
9823005044 |
| Fax |
|
| Email |
sanjaybafna16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aquil Faruqui |
| Designation |
Head Strategic Partnerships |
| Affiliation |
JCDC-CRO (Jehangir Clinical Development Centre) www.jcdc.co.in |
| Address |
Jehangir Clinical Development Centre, Clinical Research Department, Jehangir
Hospital Premises
32 Sasoon Road
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA
411001
India |
| Phone |
9820033370 |
| Fax |
|
| Email |
aquil.faruqui@jcdc.co.in |
|
|
Source of Monetary or Material Support
|
| Jehangir Clinical Development Centre, Jehangir Hospital Premises, 32 Sasoon Road www.jcdc.co.in Pune MAHARASHTRA 411001 India
Pune
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
IntegriMedical |
| Address |
805 N 4th Unit 903, Phoenix, AZ 85003, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Bafna |
Jehangir Clinical Development Centre |
Jehangir Clinical Development Centre, Jehangir Hospital Premises,
32 Sasoon Road www.jcdc.co.in
Pune
MAHARASHTRA
411001
India
Pune
MAHARASHTRA |
9823005044
sanjaybafna16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Services |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A35||Other tetanus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional
hypodermic needle (CHN) |
NFIS to be similar to CHN with respect to safety of device. |
| Intervention |
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 healthy adult volunteers with conventional hypodermic needle (CHN)-based system at 5 different sites of administration. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study performance of needle free injection system in healthy children of age group ≥ 5 to ≤ 6 years
|
To study performance of needle free injection system in healthy children of age group ≥ 5 to ≤ 6 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
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
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/08/2023 |
| Date of Study Completion (India) |
06/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a 28-day open label study in pediatric population. The study design includes 30 healthy pediatric subjects of age group ≥ 5 to ≤ 6 years for pilot clinical trial to investigate safety, tolerability, acceptability, and performance of needle free injection system in delivery of DTP vaccine. Prospective healthy pediatric subjects will be identified for the study by the study investigator/study team after the screening procedure and qualifying the study in-/exclusion criteria. This will be a one arm study. All study procedures will begin only after obtaining written informed consent from the subject’s parent’s and/or legally acceptable representatives (LARs). Each subject will receive one dose of DTP vaccine (INFANRIX, 0.5 ml, Intramuscular) in the lateral one-third of the mid-thigh muscle (skin around the chosen injection site should be intact and free from irritations, abrasions, and bruises). Subjects will be evaluated for safety, acceptability, tolerability and performance for Needle free injection system. Investigator will perform an assessment of injection site before administration of vaccine and at 2 min and between 20 to 30 min following injection. Safety of the NFIS will be assessed in terms of Injection site reactions as assessed according to the toxicity scale provided by US FDA guidance with grading 0-4 and incidence of Adverse events. Photos of injection site will be taken by the principal investigator before administration of vaccine and at 2 min and between 20 to 30 min following injection for record purpose. For visit 2 subjects will be requested to report the local site reactions and systemic reactions telephonically and send the photos of injection site to the Principal Investigator. Subjects complaining of site reactions will be called at the site for further evaluation. Acceptability and Tolerability of NFIS in pediatric population will be studied through a questionnaire (From parents/LAR and nurse and pain score using VAS scale respectively. To assess the performance of NFIS in delivering the DTP vaccine; antibody titer measurements will be performed at the baseline and at day 28 post vaccination (6) using kit and as procedure. |