| CTRI Number |
CTRI/2024/09/074054 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety of Needle Free Injection
System when administered with various types of vaccine for healthy childrens age is 6 months to 24 months |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 004/ACRS/NFIS/2024 version 1.0 dated 19 JUN 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Chandu Gangadhar Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office no 302 303 level 3 west wing nyati unitree building pune nagar road yerwada
Pune
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Pranjal Ausekar |
| Designation |
Director-Clinical Operations |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office no 302 303 level 3 west wing nyati unitree building pune nagar road yerwada
Pune
Pune
MAHARASHTRA
411006
India |
| Phone |
7507779562 |
| Fax |
- |
| Email |
pranjal@ardent-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Pranjal Ausekar |
| Designation |
Director-Clinical Operations |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office no 302 303 level 3 west wing nyati unitree building pune nagar road yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
7507779562 |
| Fax |
- |
| Email |
pranjal@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| Ardent Clinical Research Services Office 302 303 Level 3 West Wing Nyati unitree
Yerawada Pune 411006 Maharashtra INDIA |
|
|
Primary Sponsor
|
| Name |
IntegriMedical Private Limited |
| Address |
Office Survey No 614 Hissa
No 10 and 11 at post Saswad Taluka Purandar Pune 412301
Maharashtra INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vasant Madhav |
Khalatkar Hospital |
Paediatric department, 1st floor R-29 Reshimbag Umrer
Road Nagpur Maharastra
440009
Nagpur
MAHARASHTRA |
9823044438
-
vasant.khalatkar@gmail.com |
| Dr Sachin Ingle |
Lotus Multispeciality Clinic |
Ground floor shop no 4 Onyx complex Tilekar nagar chowk Yewalewadi road Tilekar nagar Kondhawa budruk pune Maharashtra 411048
Pune
MAHARASHTRA |
8149402155
-
drsachiningle803@gmail.com |
| Dr Prashant Khandgave |
Silver Birch Multispeciality Hospital |
OPD no 3 Research Room Basement UPD construction Survey no 6/1A/9/20/10/11 near Sawatamali mandir Narhe Dhayari road Punw India -411041.
Pune
MAHARASHTRA |
9892097080
-
prashantkhandgave@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Khalatkar Hospital Ethics Committee |
Approved |
| Skinovate Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy infants
aged 6 months to 24 months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Needle Free Injection System |
participants will be randomly
assigned to any vaccine via Needle Free Injection System at the time of Randomization and total study duration will be 10 days |
| Comparator Agent |
Not Applicable |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
1. Healthy infants boys or girls aged 6 months to 24 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 preterm 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 signed by the parent(s)legal guardian or any other Legally Acceptable Representative
5. Subject and parent or 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) |
|
| ExclusionCriteria |
| Details |
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 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 significant concurrent illness affecting immune response after vaccination
8. Subjects with an acute febrile illness at the time of Enrollment or randomization
9. 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
10. Known personal or maternal history of Human Immunodeficiency Virus HIV or hepatitis C seropositivity
11. Known systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine
containing the same substances
12. Known thrombocytopenia as reported by the parent or 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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the Safety of Needle Free Injection System in terms of the number of participants reporting
1 Pain
2 Redness
3 Swelling and tenderness around the injection site administered by NFIS
4 Post-immunization unsettledness or sleepiness in infants
2 To evaluate the VAS score |
1.At 30 mins of Post Vaccination
2.Day 2 of Post Vaccination
3 Day 10 of post vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To observe any other adverse events AEs and Serious Adverse Events (SAEs)
post administration of Vaccine by the NFIS system which may or may not be related to NFIS
Investigator Judgement on response rate by using the
NFIS system |
1 30 minutes postvaccination
2 Day 2 postvaccination
3 Day 10 post vaccination |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It’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). |