FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/06/014601 [Registered on: 21/06/2018] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to assess the safety and immunogenicity of a quadrivalent Human Papillomavirus vaccine in subjects aged 9 to 26 years of age. 
Scientific Title of Study   A Phase-II/III, Partially Double-blind, Randomized, Active-controlled, Multicentric Study to Assess the immunogenicity and Safety of SIIPL’s qHPV Vaccine Administered Intramuscularly in Healthy Volunteers according to a Two-dose Schedule to Cohort 1 (Girls and Boys Aged 9-14 years) and a Three-dose Schedule to Cohort 2 (Women and Men Aged 15-26 years) as Compared to Merck’s HPV6/11/16/18 vaccine (Gardasil®). 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
SII-qHPV/IN-02, Version No. 3.0, Date 27-06-2020  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  Clinical Research and Pharmacovigilance, Serum Institute Of India Pvt. Ltd
212/ 2, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  0202660241  
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  Clinical Research and Pharmacovigilance, Serum Institute Of India Pvt. Ltd
212/ 2, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  0202660241  
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  Clinical Research and Pharmacovigilance, Serum Institute Of India Pvt. Ltd
212/ 2, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  0202660241  
Fax    
Email  drhjs@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Pvt. Ltd. 212/2 Hadapsar,Pune-411028 
 
Primary Sponsor  
Name  Serum Institute of India Pvt Ltd  
Address  212/2, Hadapsar, Pune 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neerja Bhatla  All India Institute of Medical Sciences, New Delhi  Department of Obstetrics and Gynaecology, 3rd Floor, Room No. 3101 Teaching Block, Ansari Nagar, South Delhi-110029
South
DELHI 		 011-26594991

neerja.bhatla07@gmail.com 
Dr Sanjay Lalwani  Bharati Vidyapeeth Deemed University Medical College And Hospital  Department of Pediatrics, Pune - Satara road, Dhanakwadi, Katraj, Pune 411043
Pune
MAHARASHTRA 		 020-24364308

sanjaylalwani2007@rediffmail.com 
Dr Ranajit Mandal  Chittaranjan National Cancer Institute  Department of Gynecological Oncology, Research Wing, 4th floor,37, S P Mukherjee road, 700026, Kolkata
Kolkata
WEST BENGAL 		 9831002078

kranajitmandal@yahoo.co.in 
Dr Anitha Thomas  Christian Medical College  Ida Scudder Road, Vellore - 632004 Tamil Nadu
Vellore
TAMIL NADU 		 9789683006

anithomas@cmcvellore.ac.in 
Dr Latha Balasubramani  G. Kappuswami Naidu Memorial Hospital  No. 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore, Tamil Nadu 641037
Coimbatore
TAMIL NADU 		 0422-2245000

lbalasubramani70@gmail.com 
Dr Smita Joshi  Grant Medical Foundation Ruby Hall Clinic, Urban Health Centre  13,Tadiwala Road, Pune-411001.Maharashtra
Pune
MAHARASHTRA 		 9881132506

smitanjoshi18@gmail.com 
Dr Veena Kamath  Kasturba Medical College  Madhav Nagar, Near Tiger Circle, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 0820-2922324

veenak@manipal.edu 
Dr Anand Kawade  King Edward Memorial Hospital Research Centre  KEM Hospital Pune Ankit Shirdi Sai Baba Rural Hospital, A/P- Vadu Budruk, Taluka- Shirpur, District, Pune-412216
Pune
MAHARASHTRA 		 020-66037336

askawade@yahoo.com 
Dr Rajani Uday  M. S. Ramaiah Medical College and Hospital  M S Ramaiah Nagar, Mathikere, MSRIT Post, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA 		 080-23601923

rajini_uday@yahoo.co.in 
Dr Chetna Maliye  Mahatma Gandhi Institute of Medical Sciences  Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram-442102, Wardha
Wardha
MAHARASHTRA 		 07152-284341

chetna.maliye@gmail.com 
Dr A Rajeswar  MNJ Institute Of Oncology and Regional Cancer Centre  Red Hills, Lakdikapul, Hyderabad, Telangana, India-500004
Hyderabad
TELANGANA 		 9949148484

rajeshavancha@gmail.com 
Dr Vanita Suri  Post Graduate Institute of Medical Education and Research  Sector 12,Chandigarh-160012
Chandigarh
CHANDIGARH 		 0172-2756345

surivanita@yahoo.co.in 
Dr Sharmila Pimple  Tata Memorial Hospital and Cancer Research Institute  Department of Preventive Oncology, Dr Ernest Borges Marg-400 012 Mumbai, Maharashtra
Mumbai
MAHARASHTRA 		 022-24177000

pimplesa@tmc.gov.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Ansari Nagar New Delhi-110029 India  Approved 
Ethics Committee M. S Ramaiah Medical College and Hospital, Bangalore  Approved 
Ethics Committee, Christian Medical College Vellore  Approved 
G. Kuppuswamy Naidu Memorial Hospital, Institutional Ethics Committee, Coimbatore  Approved 
Institutional Ethics Committee Chittaranjan National Cancer Institute, Kolkata, West Bengal  Approved 
Institutional Ethics Committee Mahatma Gandhi Institute of Medical Sciences Sewagram Wardha, Maharashtra   Approved 
Institutional Ethics Committee Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
Institutional Ethics Committee, Bharati Vidyapeeth Deemed University, Pune  Approved 
Institutional Ethics Committee, King Edward Memorial Hospital Research Centre, Pune  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation, Pune  Approved 
Institutional Ethics Committee,MNJ Institute Of Oncology and Regional Cancer Centre, Hyderabad   Approved 
Institutional Ethics Committee-I and II, Tata memorial Hospital, Mumbai  Approved 
MAHE Ethics Committee Manipal Academy of Higher Education, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gardasil  Gardasil [Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, and 18 Vaccine, Recombinant], (manufactured and distributed by Merck Sharp and Dohme Corp) 
Intervention  SIIPL qHPV vaccine  SIIPL qHPV vaccine [Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, and 18] 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  1) Healthy ambulant male and female subjects aged 9-26 years.
2) Females with intact uterus and not pregnant.
Subject who are married/sexually active must agree to use effective contraception through Month 7 of the study.
3) Subjects who have not yet had sexual intercourse must either agree to remain abstinent through the 7 month study period, or if they become sexually active during the vaccination phase of the study, to use effective contraception for the 7 month study period.
4) Subject’s willingness and ability to comply with the requirements of the protocol as judged by the investigator.
5) Subject willing to sign a written informed consent (for subjects 18 years and above).
6) Either of the parent is willing to sign written informed consent form and subject is willing to sign written assent form (for subject <18 years of age).
7) Married females must agree to refrain from sexual activity for 48 hours prior to any
scheduled visit that includes a cervical sample. 
 
ExclusionCriteria 
Details  1) Subject has a known history of prior vaccination with HPV vaccine.
2) Subject concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
3) Subject with a current diagnosis or prior history of genital warts or treatment of genital warts.
4) Female subject with current diagnosis or history of treatment for cervical pre-malignancies or malignancy.
5) Female subject attempting to be pregnant for the study period 7 month.
6) Married female subject has clinical evidence of gross purulent cervicitis
7) Male subject with a current diagnosis or prior history of penile or anal cancers.
8) Subject has a history of any allergic diseases or severe allergic reaction to any agent
9) Subject has had an acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination.
10) Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired Human Immunodeficiency Virus infection.
11) coagulation disorder that would contraindicate IM injections.
12) Subject has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
13) Subject has history of any cancer, organ transplant or any other immune system disease.
14) Subject has had chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
15) Subject has received any oral or injectable antibiotics and/or antiviral from five days before screening through to enrolment.
16) Subject has history of receiving a blood transfusion or other blood products in three months prior to screening.
17) Subject has history of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned during the course of 7 month study period.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
GMT of antibodies to 4 HPV types
1.among girls aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil
2.among boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil
3.among women aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil
4.among men aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil.

Occurrence, intensity and relationship adverse events of SIIPL qHPV with Gardasil 		 at 7 months

 
 
Secondary Outcome  
Outcome  TimePoints 
GMT of 4 HPV types 1.In girls aged 9-14 yrs receiving SIIPL qHPV and Gardasil 2.In boys aged 9-14 yrs receiving SIIPL qHPV and 9-14 yrs of girls of Gardasil 3.At 24,36 month - among girls and boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 4.At 24,36 month - among women and men aged 15-26 yrs receiving qHPV and women aged 15-26 yrs receiving Gardasil
Persistent infections at 12, 24, 36 month in females 15-26 yr
Percentage of seroconverters at 7 month  		 at 7,12,24,36 month 
 
Target Sample Size
Modification(s)  		 Total Sample Size="2196"
Sample Size from India="2196" 
Final Enrollment numbers achieved (Total)= "2310"
Final Enrollment numbers achieved (India)="2307" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/07/2018 
Date of Study Completion (India) 16/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a Phase II/III partially double-blind, randomized, active-controlled, multicentric study with a two-dose schedule (0 and 6 months) to Cohort 1 (Aged 9-14 years) and a three-dose schedule (0, 2 and 6 months) to Cohort 2 (Aged 15-26 years) having three treatment arms in each cohort.  A total of 600 subjects will be enrolled such that 200 girls/women will be enrolled in a randomized and blinded manner in 1:1 ratio to either SIIPL’s qHPV vaccine or Gardasil (100 per age cohort) and 100 boys/men will be enrolled in a non-randomized and unblinded manner into each age cohort to receive SIIPL’s qHPV vaccine. Analysis of the reactogenicity and safety data of all 600 subjects will be performed at 7 months. Further, additional subjects will be enrolled in the phase III part of the study. Thus total sample size would be approx. 2500.  All the enrolled subjects will be considered for primary immunogenicity analysis (non-inferiority) and safety at 7 month (1 month after last dose).  Additionally, long term follow up data will obtained till 36 months.  

 
Close