CTRI/2024/05/067838 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On:
13/09/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Single Arm Study
Public Title of Study
Multicentric study to assess the safety of qHPV vaccine
Scientific Title of Study
A Phase 4 single arm multicentric study to assess the safety of SIIPL qHPV
vaccine CERVAVAC when administered in a two dose schedule to girls and
boys aged 9 to 14 years and in a three dose schedule to women and men aged 15 to 26 years
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SII-qHPV/IN-04, Version 2.0 dated 12.Jul.2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hitt Sharma
Designation
Additional Medical Director
Affiliation
Serum Institute of India Pvt Ltd
Address
Serum Institute of India Pvt Ltd
212/2, off Soli Poonawalla Road, Hadapsar, Pune
Pune MAHARASHTRA 411028 India
Phone
02026602451
Fax
Email
drhjs@seruminstitute.com
Details of Contact Person Scientific Query
Name
Dr Hitt Sharma
Designation
Additional Medical Director
Affiliation
Serum Institute of India Pvt Ltd
Address
Serum Institute of India Pvt Ltd
212/2, off Soli Poonawalla Road, Hadapsar, Pune.
Pune MAHARASHTRA 411028 India
Phone
02026602451
Fax
Email
drhjs@seruminstitute.com
Details of Contact Person Public Query
Name
Dr Hitt Sharma
Designation
Additional Medical Director
Affiliation
Serum Institute of India Pvt Ltd
Address
Serum Institute of India Pvt Ltd
212/2, off Soli Poonawalla Road, Hadapsar, Pune.
Pune MAHARASHTRA 411028 India
Phone
02026602451
Fax
Email
drhjs@seruminstitute.com
Source of Monetary or Material Support
Serum Institute of India Pvt. Ltd., 212/2 Off Soli Poonawalla Road, Hadapsar, Pune-411028. Maharashtra, India.
Primary Sponsor
Name
Serum Institute of India Pvt Ltd
Address
212/2, Off Soli Poonawalla Road, Hadpasar, Pune 411028
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 23
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Jyoti Meena
All India Institute of Medical Sciences
All India Institute of Medical Sciences,
Department of Obstetrics and Gynaecology, Room N0.3082A, Third floor, Teaching Block, Ansari Nagar, New Delhi - 110029 New Delhi DELHI
9953937130
drjyotirajesh@gmail.com
Dr Shalini Rajaram
All India Institute of Medical Sciences,Rishikesh
All India Institute of Medical Sciences,
Rishikesh – 249203, Uttarakhand Dehradun UTTARANCHAL
9810704434
rajaram.shalini@gmail.com
Dr Bhaskar Jedhe Deshmukh
Baramati Hospital Pvt Ltd
Baramati Hospital Pvt. Ltd, Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati - 413102 Pune MAHARASHTRA
9822402772
bhaskar.jedhe@gmail.com
Dr Sonali Palkar
Bharati Vidyapeeth Deemed to be University Medical College Hospital and Research Centre
Bharati Vidyapeeth Deemed to be University Medical College Hospital and Research Centre,
Pune-Satara Road, Dhankawadi - 411043, Pune. Pune MAHARASHTRA
9881008717
palkarsh@gmail.com
Dr Jayashree
Cancer Institute (WIA)
Department of Gynaecological Oncology,
Cancer Institute (WIA), Adyar,
38, Sardar Patel Road, Adyar,
Chennai, Tamil Nadu-600036 Chennai TAMIL NADU
9731024312
vassnthjayashree@gmail.com
Dr Anitha Thomas
Christian Medical College
Christian Medical College, Ida Scudder Road, Vellore-632004, Tamil Nadu Vellore TAMIL NADU
9789683006
anithomas@cmcvellore.ac.in
Dr Latha Balasubramani
G Kuppuswamy Naidu Memorial Hospital
G. Kuppuswamy Naidu Memorial Hospital,
No. 6327, Nethaji Road, Pappanaickenpalayam,
Coimbatore-641037, Tamil Nadu Coimbatore TAMIL NADU
9585504223
lbalasubramani70@gmail.com
Dr Abhishek Agarwal
Guru Nanak Hospital
Guru Nanak Hospital, NH-2, Near Palwal Bus Stand, Shiv Colony, Palwal, Haryana - 121102 Faridabad HARYANA
9582366630
abhishek.agarwal@inclentrust.org
Dr Sunil Kohli
Hamdard Inst.of Medical Sci. and Research with CHRD–SAS, Hakeem Abdul Hameed Centenary Hospital
Clinical Research Centre – HIMSR with CHRD-SAS
Block B, Basement,
Hamdard Institute of Medical Sciences and Research (HIMSR), with
Centre for Health Research and Development – Society for Applied Studies (CHRD-SAS)
Hakeem Abdul Hameed Centenary Hospital (HAHCH),
Guru Ravidas Marg, Hamdard Nagar, New Delhi – 110062 South DELHI
9873351206
drskohli.himsr@gmail.com
Dr Subhash Chandra B J
JSS Hopsital
JSS Hopsital,
Department of General Medicine,
Mahatma Gandhi Road, Mysore - 570004, Karnataka Mysore KARNATAKA
9845197851
drsubhashbj@gmail.com
Dr Veena Kamath
Kasturba Medical College
Department of Community Medicine,
Kasturba Medical College, Manipal Academy of Higher Education,
Madhava Nagar, Manipal - 576104, Karnataka Udupi KARNATAKA
9845304647
veenak@manipal.edu
Dr Aditi Apte
KEM Hospital Research Centre
Community Health Research Unit (CHRU) - KEM Hospital Research Centre.
Third Floor, Shrivinayak Hospital, Mulewadi Road, P.O.
Manchar, Taluka Ambegaon, District Pune - 410503 Pune MAHARASHTRA
9975950227
aditi.apte@kemhrcvadu.org
Dr Yogesh Somani
Nargis Dutt Memorial Cancer Hospital
Nargis Dutt Memorial Cancer Hospital,
Agalgaon Road, Barshi- 413401,
Dist. Solapur, Maharashtra Solapur MAHARASHTRA
9422457255
yjsomani@hotmail.com
Dr Santanu Deb
Nazareth Hospital
Nazareth Hospital,
Arbuthnot Rd, near Police Point, Nongkynrih, Laitumkhrah, Shillong, Meghalaya 793003 East Khasi Hills MEGHALAYA
9436116560
santanudebdoc@gmail.com
Dr S K Raut
Noble Hospital Pvt Ltd
Noble Hospital Pvt Ltd
153, Magarpatta City Road, Hadapsar, Pune - 411013 Pune MAHARASHTRA
9423581029
skrcorporate@yahoo.co.uk
Dr Rashmi Bagga
PGIMER, Chandigarh
Department of Obstetrics and Gynaecology,
3rd Floor. F- Block, Nehru Building, Sector-12,
PGIMER, Chandigarh - 160012, Punjab Chandigarh CHANDIGARH
9872494602
rashmibagga@gmail.com
Dr Smita Joshi
Prayas Hospital
Prayas, Karve Road, Chatrapati Sambhaji Maharaj Bridge (lakadi Pul) corner, near Panchaleshwar Temple, Deccan Gymkhana, Pune - 411004 Pune MAHARASHTRA
9881132506
smita.j@prayaspune.org
Dr Savita Verma
Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences, University of Health Sciences
Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences, University of Health Sciences, Room No. 428, Department of Pharmacology, Rohtak - 124001, Haryana Rohtak HARYANA
9812283746
verma.savi@gmail.com
Dr Rajini Uday
Sapthagiri Institute of Medical Sciences and Research Centre
Sapthagiri Institute of Medical Sciences and Research Centre, 15 Chikkasandra, Hesaraghatta Main road, Bangalore -560090 Bangalore KARNATAKA
9448955892
rajini_uday@yahoo.co.in
Dr Saswati Tripathy
SRM Medical College Hospital and Research Centre
SRM Medical College Hospital and Research Centre, Department of Obstetrics and Gynaecologi, SRM Nagar, Kattankulathur, Chengalpattu - 603203, Tamil Nadu Kancheepuram TAMIL NADU
Institutional Ethics Committee, PGIMS, University of Health Sciences, Rohtak
Approved
Institutional Ethics Committee, Sapthagiri Institute of Medical Sciences and Research, Bangalore
Approved
Institutional Ethics Committee, Tata Memorial Hospital
Approved
Institutional Review Board and Ethics Committee, Christian Medical College, Vellore
Approved
KEM Hospital Research Centre Ethics Committee
Approved
Manipal Academy of Higher Education Ethics Committee, Manipal, Karnataka.
Approved
SRM MCH and RC, Ethics Committee, Kattankulathur, Chengalpattu
Approved
Tata Medical Center Institutional Review Board, Kolkata
Approved
The INCLEN Independent Ethics Committee, New Delhi
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not Applicable
Not Applicable
Intervention
SIIPL’S qHPV VACCINE (CERVAVAC®)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine (Recombinant). The 0.5 mLof the vaccine will be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh in 9-14 years at 0 and 6 months and 15-26 years 0, 2 and 6 months.
Inclusion Criteria
Age From
9.00 Year(s)
Age To
26.00 Year(s)
Gender
Both
Details
1. Female and male subjects aged 9-26 years.
2. Subjects who are eligible for receiving CERVAVAC vaccine according to the approved local prescribing information and as per the Investigator’s opinion.
3.Subject’s or their parent’s willingness and ability to comply with the requirements of the protocol.
4.Subject willing to sign a written informed consent.
5. Either of the parent is willing to sign written informed consent form for subject less than years of age and subject is willing to sign written assent form.
ExclusionCriteria
Details
1.Subject who has a known history of prior vaccination with HPV vaccine.
2. Subject who was previously enrolled in HPV vaccine surveillance and had received a similar active agent.
3.Subject who had received any investigational product within 30-days prior to their first visit.
4.Hypersensitivity to the active substances or to any of the excipients of the vaccine including severe allergic reactions to yeast, a vaccine component.
5.Pregnant females or females planning to become pregnant during the study duration.
6.Any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1) Incidence, severity, and relationship of local and systemic solicited adverse events (AE) up to 7 days following each vaccination.
2) Incidence, severity, and relationship of unsolicited adverse events (AE) occurring up to end of study (EOS) visit (Day 210).
3) Incidence, severity, and relationship of serious adverse events (SAE) occurring up to end of study (EOS) visit (Day 210).
1) Local and systemic AE up to 7 days.
2) Unsolicited AE up to day 210.
3) SAEs up to day 210.
Secondary Outcome
Outcome
TimePoints
Not Applicable
Not Applicable
Target Sample Size
Total Sample Size="2000" Sample Size from India="2000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol
Who will be able to view these files? Response - Researchers who provide a methodologically sound proposal.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [drhjs@seruminstitute.com].
For how long will this data be available start date provided 01-01-2027 and end date provided 30-06-2027? Response - Immediately following publication. No end date.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
A Phase-IV single arm, multicentric, active study with a primary objective to assess the safety of SIIPL’s qHPV vaccine (CERVAVAC®) when administered as a two-dose schedule (0 and 6 months) to girls and boys aged 9-14 years and as a three-dose schedule (0, 2 and 6 months) to women and men aged 15-26 years. A total of 2000 subjects, 1000 subjects in each of the age cohorts, 9-14 years, and 15-26 years will be enrolled in the study. 0.5-ml suspension of CERVAVAC vaccine will be administered as an Intramuscular (IM) injection in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Subjects will be followed up till one month post the last dose of study vaccine with the duration of study participation for each subject being at least 7 months. Assessment of incidence, severity, and relationship of local and systemic solicited adverse events up to 7 days following each vaccination, unsolicited adverse events occurring up to end of study visit (Day 210), and serious adverse events (SAE) occurring up to end of study visit (Day 210) will be done in the study.