| CTRI Number |
CTRI/2025/07/090243 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial of Quadrivalent Human Papillomavirus (HPV) vaccine in healthy subjects. |
|
Scientific Title of Study
|
A Phase-I, open label clinical trial to assess the safety and immunogenicity of Quadrivalent Human Papillomavirus (HPV) vaccine in healthy subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC24001, Version No. 01, Dated 08.07.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Head (President) CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002564 |
| Fax |
|
| Email |
arani.chatterjee@cadilapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Amarsheda |
| Designation |
Asst. General Manager - CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002565 |
| Fax |
|
| Email |
ashish.a@cadilapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Patel |
| Designation |
General Manager (Head) Clinical Trial |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002566 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.com |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Limited
1389, Trasad road, Dholka, Ahmedabad, Gujarat. India. Pin code: 382225 |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road, Dholka,
Ahmedabad - 382225, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Maharshi Desai |
Apollo Hospital International Ltd. |
Department of critical care.Plot No. 1A, Bhat, GIDC Estate, Gandhinagar 382428.
Ahmadabad
GUJARAT |
9825044828
maharshi_desai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Quadrivalent HPV vaccine |
Single Intramuscular administration of 0.5 ml into the deltoid region |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy adult female subjects aged between 18-45 years.
2.BMI within normal limit of 18.50-30.00 kg/m2 (inclusive both).
3.Subjects in good health at screening and enrollment into the study.
4.As per investigator, subjects should be eligible to participate in the study including ability to provide written informed consent and comply with all study requirements.
5.Documented negative test for HIV-1/2, HBsAg and HCV.
6.Sexually active subjects willing to use an
effective method of contraception during the entire study.
7.Female subjects having a negative urine
pregnancy at screening visit. |
|
| ExclusionCriteria |
| Details |
1.History of HPV vaccination or wart or condyloma or cervical intraepithelial neoplasia (CIN) / abnormal cervical cancer tests in females.
2.History of adverse reactions including allergy or hypersensitivity reaction to any vaccine.
3.Acute illness and/or fever at the time of vaccination or during the past 7 days.
4.History of disease or any underlying medical conditions, any drug intake in the past two weeks of proposed vaccination date.
5.Subject with known or suspected immunodeficiency or an auto-immune disease.
6. Subjects using any immunosuppressive therapy, use of nontopical antiviral therapy with activity against herpes virus.
7.Any vaccine administration within the last 30 days or planned to be administered during the study period.
8.Pregnant and lactating female subjects.
9.Subjects with diabetes.
10.Subjects with any serious medical condition in last 6 months.
11.Participation in another interventional clinical trial during the past 3 month prior to screening.
12.Any clinically significant abnormal laboratory values, ECG or chest X-Ray findings.
13.History or presence of significant alcoholism, drug abuse in the past 1 year.
14.History or presence of significant smoking.
15.Subject has any plans to relocate from the area prior to the completion of the study.
16.Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and reactogenicity of a test vaccine. |
Till Day 30 days post-vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the immunogenicity results of the test vaccine. |
On Day 30 after vaccination |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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
|
This is a Phase-I, prospective, FIH, open label clinical study of HPV vaccine with objective to evaluate the safety, reactogenicity, and immunogenicity of Quadrivalent HPV vaccine of Cadila Pharmaceuticals Limited, India in healthy, adult female subjects. Safety and reactogenicity will be evaluated based on the solicited and unsolicited AEs post each vaccination. |