FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073978 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 21/09/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To check the safety of Needle Free Injection System when administered with different types of vaccine for healthy childrens age is below 6 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 below 6 months 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
005/ACRS/NFIS/2024 V 1.0 dated 19/JUN/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Chandu Devanpally 
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office 302 303 Level 3 West Wing Nyati unitree Yerawada
Pune
Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  MrsPranjal Ausekar 
Designation  Director-Clinical Operations 
Affiliation  Ardent Clinical Research Services 
Address  Office 302 303 Level 3 West Wing Nyati unitree Yerawada
Pune
Pune
MAHARASHTRA
411006
India 
Phone  7507779562  
Fax  -  
Email  pranjal@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  MrsPranjal Ausekar 
Designation  Director-Clinical Operations 
Affiliation  Ardent Clinical Research Services 
Address  Office 302 303 Level 3 West Wing Nyati unitree Yerawada
Pune
Pune
MAHARASHTRA
411006
India 
Phone  7507779562  
Fax  -  
Email  pranjal@ardent-cro.com  
 
Source of Monetary or Material Support  
IntegriMedical Private Limited Office Survey No 614 Hissa No 10 11 at post Saswad Taluka Purandar Pune 412301 Maharashtra INDIA 
 
Primary Sponsor  
Name  IntegriMedical Private Limited 
Address  Office Survey No 614 Hissa No 10 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  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
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 Pune Maharashtra India 411041
Pune
MAHARASHTRA 		 9892097080
-
drprashantkhandgave@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Skinovate Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy infants aged below 6 months 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Needle Free Injection System (N-FISTM)  Participants will receive the vaccine (Various types of vaccine irrespective of the brand) through the Needle Free Injection System (N-FISTM) for 10 days of duration 
Comparator Agent  Not Applicable  NA 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  6.00 Month(s)
Gender  Both 
Details  1 Healthy infants boys or girls aged less than 6 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 pre-term 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 (ICF) signed by the parent(s) or any other Legally
Acceptable Representative (LAR)
5 Subject and parent/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 [BCG] 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 signi􀏐icant concurrent illness affecting immune response after vaccination
8 Subjects with an acute febrile illness at the time of enrolment/randomization
9. Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth or long-term systemic corticosteroid therapy (prednisone or
equivalent for more than 2 consecutive weeks since birth)
10 Known personal or maternal history of Human Immunode􀏐iciency Virus (HIV) or hepatitis C seropositivity
11 Known systemic hypersensitivity to any of the vaccine components, or history of a
life threatening reaction to the trial vaccine or a vaccine containing the same
substances
12 Known thrombocytopenia, as reported by the parent/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 (N-FISTM) in terms of the
number of participants reporting
a) Pain
b) Redness
c) Swelling and tenderness around the injection site administered by N-FISTM
d) Post immunization unsettledness or sleepiness in infants
2 To evaluate the NIPS score at 30 mins of Vaccination 		 1 At 30 minutes of post-vaccination
2 Day 2 post vaccination
3 Day 10 post vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
1 To observe any other adverse events and Serious Adverse Events post administration of Vaccine by the N-FISTM system which may or may not be related to N-FISTM.
2 Investigator Judgement on response rate by using the N-FISTM system 		 1 At 30 minutes of post-vaccination.
2 Day 2 post vaccination
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="6"
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  
This is 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).
 
Close