CTRI/2017/02/007785
Completed
Phase 1
A phase-I, open label clinical trial to assess the safety and tolerability ofrecombinant quadrivalent Human Papilloma Virus (qHPV) vaccinemanufactured by Serum Institute of India Pvt.Ltd. in healthy adultvolunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Serum Institute of India Pvt Ltd
- Enrollment
- 47
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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