| CTRI Number |
CTRI/2024/08/073010 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the Safety of Needle Free Injection System when administered Hexavalent Vaccine in Healthy childrens Aged 15 to 18 Months |
|
Scientific Title of Study
|
A Prospective Randomized Single Center Two Arm Open Label Parallel Group
Comparative Study to Evaluate the Safety of Needle Free Injection System
(N-FIS TM) and
Immunogenicity of Hexavalent Vaccine (HEXASIIL) in Healthy Infants Aged 15 to 18
Months |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 003/ACRS/NFIS/2024 1.0 dated 17th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Khandgave |
| Designation |
MBBS MD Paediatrics DCH |
| Affiliation |
Silver Birch Multispeciality hospital |
| Address |
Pediatric Department OPD No3 Basement
Silver Birch Multispeciality
Hospital UPD Construction S No 6 Plot No 1 To Plot No 4
Dhayari Road near Sawatamali Mandir Narhe
Pune
MAHARASHTRA
411041
India |
| Phone |
9145703815 |
| Fax |
- |
| Email |
drprashantkhandgave@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
office no 302 303 Room no 01 clinical research department level 3 Nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
office no 302 303 Room no 01 Clinical research department level 3 Nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Khandgave |
Silver Birch Multispeciality Hospital |
Pediatric Department OPD No3 Basement
U P D Construction S No 6
Plot No 1 To Plot No 4
Dhayari Road near Sawatamali Mandir Narhe Pune Maharashtra
Pune
MAHARASHTRA |
9145703815
-
drprashantkhandgave@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sai Krupa Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Infants Aged 15 to 18
Months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hexavalent vaccine via Needle Free Injection System |
One dose of 0.5mL hexavalent vaccine will be administered through the intramuscular route using the on day 1 as a single dose |
| Comparator Agent |
Hexavalent vaccine via Traditional Intramuscular injection |
One dose of 0.5mL hexavalent vaccine will be administered through the intramuscular route using the traditional intramuscular injection on day 1 as a single dose |
|
|
Inclusion Criteria
|
| Age From |
15.00 Month(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
1 Healthy infants either boys or girls aged 15 to 18 months at the time of enrollment
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 Assent Form (ICF) signed by the parent or any other Legally
Acceptable Representative (LAR)
5 Subject and parent/legally acceptable representative are able to attend all scheduled
visits and to 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 previous Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis and Haemophilus influenzae Type b Conjugate infection or Hexavalent (HEXASIIL) vaccination or if they had been exposed to any of these three diseases within 30 days of trial commencement
4 Subjects having received the Hexavalent (HEXASIIL) vaccine less than 3 months back
5 Subjects with a history of convulsions epilepsy other central nervous system diseases
a severe disease of haematopoietic system decompensated heart disease or impaired
renal function
6 Any other parenteral vaccine administration within 30 days of initiation of the study or
during the study
7 A history of serious chronic illness major congenital defects immunosuppression
(immunosuppressive illness or therapy)
8 Subjects who have received blood blood products or immunoglobulins during the preceding 3 months
9 Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
10 Subjects with an acute febrile illness at the time of enrolment randomization
11 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)
12 Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
13 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
14 Known thrombocytopenia as reported by the parent legally acceptable representative
15 Any bleeding disorder or receipt of anticoagulants in 3 weeks prior to the screening and randomization
16 In an emergency setting or hospitalized involuntarily
17 Chronic illness that in the opinion of the investigator is at a stage where it might
interfere with trial conduct or completion
18 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
19 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 NFIS system
2 To evaluate the number of participants reporting solicited injection site reactions solicited or unsolicited systemic reactions |
1 Day 1 to Day 28
2 Day 1 to Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the levels of antibody concentration to the vaccine antigens following a single dose of the HEXAVALENT vaccine |
Day 1 to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The design is a Prospective, randomized, single-center, two arm study to generate data for the evaluation of Safety and Immunogenicity [as measured by the trial participants who experience Adverse Event/s (AE/s) &/or Serious Adverse Event/s (SAE/s) by using NIFSTM and assess the levels of antibodies concentration]. Trial participants will be assigned randomly to one of two groups, with a 1:1 ratio: either the intervention group (receiving HEXAVALENT vaccine via the intramuscular route using the NIFSTM) or the comparator group (receiving HEXAVALENT vaccine via traditional intramuscular injection). |