To assess potential hazards, including immediate adverse events after bivalent and quadrivalent HPV vaccines immunizations in healthy Indian women aged 18-25 years.
- Registration Number
- CTRI/2013/11/004140
- Lead Sponsor
- Madhusudan B Vakharia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1. Able to fill the questionnaires used in this study.
2. Able to give a written informed consent.
3. Able to attend all scheduled visits.
1. No hospitalization within 21 days prior to study entry.
2. Oral temperature of 38.3 C (101 F) or greater within 72 hours prior to each study vaccination.
3. Hypersensitivity to latex.
4. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
5. They have surgery planned during the study period.
6. Pregnant or immune compromised women should be avoided.
7. Any other condition including abuse of alcohol, drug addiction of imposed confinement that may interfere with ability to comply with trial procedures.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method