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CTRI Number  CTRI/2026/04/109190 [Registered on: 23/04/2026] Trial Registered Prospectively
Last Modified On: 22/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Needle free device HPV Vaccine]  
Study Design  Other 
Public Title of Study   Study in India to Compare Safety and Immune Response of HPV Vaccine Given by Needle-Free Device versus Traditional Needle in Healthy People Aged 9–26 Years”  
Scientific Title of Study   An open-label, Randomized, Controlled Trial to assess Safety and Immunogenicity of qHPV intramuscular Vaccine administered using IntegriMedical® Needle-Free vs. Needle Injection In Healthy Individuals Aged 9-26 years, in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IM-NFIS-HPV-25-002 Version 1.0 date 5 Jan 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitin Shah Kantilal  
Designation  Consultant Pediatrician & Pediatric hematologist oncologist  
Affiliation  P.D. Hinduja National Hospital and Medical research Center 
Address  P.D. Hinduja National Hospital and Medical research Center, Veer Savarkar Marg, Mahim, Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9821037201  
Fax    
Email  drnitinshah@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ankur Naik 
Designation  Chief technology officer 
Affiliation  IntegriMedical Private Limited 
Address  IntegriMedical Private Limited Survey No. 624, Hissa No. 10 & 11 At Post Saswad, Taluka Purandhar, Pune Maharashtra, India

Pune
MAHARASHTRA
412301
India 
Phone  7069553814  
Fax    
Email  ankur@integrimedical.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeraj Prasad 
Designation  Deputy Director – Operations 
Affiliation  JSS Medical Research Asia Pacific Private Limited 
Address  JSS Medical Research Asia Pacific Private Limited, Tower 2, 1st Floor, South Wing, L&T Business Park Plot no. 12/4, Sector 27 D
Near Sarai Khawaja Metro Station Delhi Mathura Road, Faridabad – 121003, Haryana, India
Faridabad
HARYANA
121003
India 
Phone  9930740633  
Fax    
Email  neeraj.prasad@jssresearch.com  
 
Source of Monetary or Material Support  
Mr. Ankur Naik IntegriMedical Private Limited  
 
Primary Sponsor  
Name  Mr Sarvesh Mutha 
Address  IntegriMedical Private Limited  
Type of Sponsor  Other [(Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Kawade  KEM Hospital Research Centre  Vadu Rural Health Program KEM Hospital Research Centre, PO Vadu Budruk, Taluka Shirur, District Pune - 412216, Maharashtra, India
Pune
MAHARASHTRA 		 98505559983

anand.kawade@kemhrcvadu.org 
Dr Nitin Shah  P. D. Hinduja Hospital and Medical Research Centre, Mumbai  Veer Savarkar Marg, Mahim, Mumbai-400016, Maharashtra, India.
Mumbai
MAHARASHTRA 		 9821037201

drnitinshah@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee P.D Hinduja Hospital & MRC, S2 Building 21st Floor, Veer Savarkar Marg, Mahim, Mumbai-400016  Approved 
KEM Hospital Research Centre, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Needle free device HPV Vaccine 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Hypodermic Needle (CHN) Injection (25 G x 1-inch needle) with intramuscular 0.5 mL suspension of qHPV vaccine   Participants will receive two or three doses of 0.5 ml of qHPV vaccine as per their age cohort and recommended immunization schedule: 3. Cohort-1: Age 9–14 years (both inclusive): Two-dose schedule (at Day 0 and 6 months) 4. Cohort 2: Age 15–26 years (both inclusive): Three-dose schedule (at Day 0, 2 months, and 6 months) Dose:0.5 mL suspension of qHPV vaccine Frequency: two dose or three dose For 2-dose schedule: Visit 1/ Screening / Day 0 (Vaccination Visit) Visit 4/ Day 180 (+30 Days) (Vaccination Visit) For 3-dose schedule: Visit 1/ Screening / Day 0 (Vaccination Visit) Visit 4/ Day 60 (+30 Days) (Vaccination Visit) Visit 7/ Day 180 (+30 Days) (Vaccination Visit) Rout of administration: Intramuscular  
Intervention  IntegriMedical Needle-Free Injection System (IM-N-FIS) with intramuscular 0.5 mL suspension of qHPV vaccine   Participants will receive two or three doses of 0.5 ml of qHPV vaccine as per their age cohort and recommended immunization schedule: 1. Cohort-1: Age 9–14 years (both inclusive): Two-dose schedule (at Day 0 and 6 months) 2. Cohort 2: Age 15–26 years (both inclusive): Three-dose schedule (at Day 0, 2 months, and 6 months) Dose:0.5 mL suspension of qHPV vaccine Frequency: two dose or three dose For 2-dose schedule: Visit 1/ Screening / Day 0 (Vaccination Visit) Visit 4/ Day 180 (+30 Days) (Vaccination Visit) For 3-dose schedule: Visit 1/ Screening / Day 0 (Vaccination Visit) Visit 4/ Day 60 (+30 Days) (Vaccination Visit) Visit 7/ Day 180 (+30 Days) (Vaccination Visit) Rout of administration: Intramuscular  
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  Participants will be enrolled in the study if they meet all the following criteria:
1. Healthy female and male participants of age 9-26 years (both inclusive) at the time of the screening
2. Clinically healthy, as established by medical history and physical examination before entering the study
3. Female participants with childbearing potential, not pregnant at the time of vaccination
4. Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap) 30 days prior to the enrollment and throughout the study period
5. Able to provide informed consent and assent (whichever applicable)
6. Able to comply with the study requirements

 
 
ExclusionCriteria 
Details  Participants will be excluded from the study if they meet any of the following criteria:
1. Previous vaccination against HPV
2. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period
3. Administration of any other vaccine within 30 days prior to study enrollment, or within 30 days of each study vaccination visits except for routine vaccines like rabies vaccine or tetanus containing vaccine
4. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period
5. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
6. History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast
7. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted
8. Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
9. Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period
10. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature 37.5 degree Celsius
11. Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Incidence of immediate adverse events 30 minutes after each vaccination
• Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination
• Incidence, severity, and relationship of unsolicited adverse events throughout the study period
• Incidence, severity and relationship of serious adverse events throughout the study period
• Pain assessment using Visual Analog Scale (VAS) at the time of vaccination  		 • Incidence of immediate adverse events 30 minutes after each vaccination
• Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination
• Incidence, severity, and relationship of unsolicited adverse events throughout the study period
• Incidence, severity and relationship of serious adverse events throughout the study period
• Pain assessment using Visual Analog Scale (VAS) at the time of vaccination  
 
Secondary Outcome  
Outcome  TimePoints 
• Geometric Mean Titre of antibodies to HPV types 6, 11, 16, and 18 among participants receiving vaccination either with IM-N-FIS or CHN, 30 days after last dose of vaccination i.e. on Day 210.

• Percentage of participants with seroconversion to HPV types 6, 11, 16, and 18, 30 days after last dose of vaccination with either IM-N-FIS or CHN i.e. on Day 210.

• Fold rise of antibodies to HPV types 6, 11, 16, and 18 among participants receiving vaccination either with IM-N-FIS or CHN, 30 days after last dose of vaccination i.e. on Day 210.
 		 Immunogenicity samples would be collected at Pre dose visit 1 and at EOS visit 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/04/2027 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This Phase IV clinical trial is a prospective, open-label, randomized controlled trial designed to assess the safety and immunogenicity qHPV intramuscular vaccine administered using IntegriMedical needle-free injection system (IM-N-FIS) vs. conventional hypodermic needle CHN injection in healthy individuals aged 9-26 years (both inclusive), in India.

 
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