| CTRI Number |
CTRI/2024/01/061633 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the safety of Needle free injection and immunegenicity of Tresivac MMR vaccine in healthy infants |
|
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 (NFIS) and Immunogenicity of Tresivac MMR Vaccine in Healthy Infants using NFIS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 002/ACRS/NFIS/2023 |
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 305, 309 Level 3 West Wing Nyati unitree Yerawada
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 305, 309 Level 3 West Wing Nyati unitree Yerawada Pune
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 305, 309 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 |
|
|
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-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 B S Ratta |
Ruby Hall Clinic |
Grant Medical Foundation Ruby Hall Clinic, Poly OPD, Ground Floor, 40, sasson Road, Pune-411001, Maharashtra
Pune
MAHARASHTRA |
9822078715
-
bsratta05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Poona Medical Research Foundation Ruby Hall Clinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
9 to 12 Months Infants |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Needle free injection system |
Participants will be randomly assigned to Needle free Injection System(NFIS) arm to receive single dose of tresivac MMR vaccine. |
| Comparator Agent |
Traditional Subcutaneous Injection |
Participants will be randomly assigned to traditional Subcutaneous injection arm to receive single dose of tresivac MMR vaccine. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1 Healthy Infant(s) of 9 months to 12 months of age on the day of inclusion
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 Informed Consent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR)
4 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5 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 measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement.
4 Subjects having received measles vaccine less than 3 months back.
5 Subjects with a history of convulsions epilepsy other central nervous system diseases 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 enrollment/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 Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
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
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1)To evaluate the Safety of Needle Free Injection System (NFIS)
(Note- safety in terms of Pain redness swelling itching observed at the injection site and any other adverse events or serious adverse events due to NFIS)
2)To evaluate the number of participants reporting solicited injection site reactions solicited &/or unsolicited systemic reactions after administration of Tresivac MMR vaccine |
(Pre vaccination) Day 1 to Day 28 (post-vaccination |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1)Evaluate the levels of antibodies concentration to the vaccine antigens following single dose of Tresivac MMR vaccine |
(Pre vaccination) Day 1 to Day 28 (post-vaccination |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
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 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 Needle Free Injection System (NFIS) and assess the levels of antibodies concentration] for 28 days Trial participants will be assigned randomly to one of two groups, with a 1:1 ratio: either the intervention group (receiving Tresivac MMR vaccine using NFIS) or the comparator group (receiving Tresivac MMR vaccine using traditional subcutaneous injection). |