A Clinical study on quadrivalent Human Papilloma virus vaccine
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2017/02/007785
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 47
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. Subjectâ??s willingness and ability to comply with the requirements of
the protocol.
5. Subject willing to sign a written informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of immediate adverse events after single dose. <br/ ><br>2. Occurrence of solicited adverse reactions within 7-day postvaccination <br/ ><br>follow-up period. <br/ ><br>3.Occurrence of solicited adverse events within 30 days after vaccination.Timepoint: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.
- Secondary Outcome Measures
Name Time Method 1. Occurrence of unsolicited adverse events, including serious adverse <br/ ><br>events within 30 days after vaccination.Timepoint: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.