| CTRI Number |
CTRI/2017/02/007785 [Registered on: 06/02/2017] Trial Registered Prospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study on quadrivalent Human Papilloma virus vaccine |
|
Scientific Title of Study
|
A phase-I, open label clinical trial to assess the safety and tolerability of
recombinant quadrivalent Human Papilloma Virus (qHPV) vaccine
manufactured by Serum Institute of India Pvt.Ltd. in healthy adult
volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SII-qHPV/IN-01 Version no. 1 Dated 3rd August 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil K |
| Designation |
Head, Human Pharmacology Unit |
| Affiliation |
|
| Address |
Human Pharmacology Unit,
Syngene International Limited
Clinical Development
Tower–1, Semicon Park
Electronics City Phase II
Bangalore.
Bangalore
KARNATAKA
560 100
India |
| Phone |
080-28082771 |
| Fax |
080-28082722 |
| Email |
Anil.Dr@syngeneintl.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, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602451 |
| 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, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602451 |
| Fax |
|
| Email |
drhjs@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
212/ 2, Hadapsar, Pune, Maharashtra, 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 Anil K |
Human Pharmacology Unit Syngene International Limited |
Clinical Development
Tower – 1, Semicon Park
Electronics City Phase II
Bangalore
Bangalore
KARNATAKA |
080-28082780
Anil.Dr@syngeneintl.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human Papilloma Virus Vaccine |
0.5 ml intramuscular in the deltoid region of the upper arm |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult male aged between 18-26 years and female subjects
aged between 18-45 years and normal Body Mass Index (18.5 to
24.9 kg/m2) with minimum of 50 kg weight.
2. Healthy subjects as established by personal medical history, physical
examination, laboratory investigation during screening and as per the
clinical judgment of the Investigator.
3. Sexually active participants to be using an effective method of
contraception (i.e. intrauterine device or hormonal contraception or
condom, diaphragm, cervical cap).
4. Subject’s willingness and ability to comply with the requirements of
the protocol.
5. Subject willing to sign a written informed consent. |
|
| ExclusionCriteria |
| Details |
1. History of HPV vaccination or HPV infection
2. Female participant who is pregnant or breast-feeding, or wanting to
fall pregnant during trial participation.
3. History of abnormal cervical cancer tests in females or history of
genital warts in females and males.
4. History of any surgical procedure for the removal of the uterus or
hysterectomy.
5. History of major congenital defects or illness.
6. Investigator site personnel directly affiliated with this study.
7. Acute illness and/or fever at the time of vaccination or during the past 7 days.
8. Administration of corticosteroids, cytotoxic agents or radiotherapy or other immune-modifying
drugs in last 3 months.
9. Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment.
10. History of receipt a blood transfusion or other blood products.
11. Use of any investigational or non-registered drug.
12. History of administration of any vaccine in past 30 days or during the study.
13. History of any major illness.
16. History of anaphylactic shock
17. Participant having any allergies to medications and food.
18. History or presence of significant alcoholism, drug abuse in the past one year.
19. History or presence of significant smoking.
20. Reactive serology for HIV, hepatitis B and hepatitis C viruses
21. Abnormal ECG and chest X-ray
22. Participation in a drug research study within past 3 months or planned participation during the study.
23. Participant has any plans to relocate from the area prior to the completion of the study.
24. 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 |
1. Occurrence of immediate adverse events after single dose.
2. Occurrence of solicited adverse reactions within 7-day postvaccination
follow-up period.
3.Occurrence of solicited adverse events within 30 days after vaccination. |
Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Occurrence of unsolicited adverse events, including serious adverse
events within 30 days after vaccination. |
Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="47" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
14/02/2017 |
| Date of Study Completion (India) |
15/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is designed as a single center trial to assess safety and tolerability of SIIPLs qHPV vaccine in healthy adults. A single dose of Quadrivalent HPV vaccine will be administered in healthy adult volunteers. Active follow up for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, follow up for unsolicited AEs and SAEs will be carried out over the period between enrollment and 30 days after vaccination on all subjects by using diary cards. Independent oversight of this study will be provided by a DSMB. |