CTRI/2015/09/006183
Completed
Phase 4
A Post Marketing Surveillance to assess the safety of Gardasil® in females of 9 to 45 years in routine clinical care - NA
MSD Pharmaceuticals PvtLtd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Preventative Cervical Cancer
- Sponsor
- MSD Pharmaceuticals PvtLtd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who provide voluntary written informed consent/ assent to participate in the study.
- •Female subjects 9 to 45 years (inclusive) who opt for vaccination.
- •Subjects who would receive Gardasil® according to the approved local prescribing information as per the Investigatorâ??s opinion.
- •Subjects who the investigator believes that they or their parents/ guardians can and will comply with the requirements of the protocol.
- •Subjects should own a phone so as to enable the investigator or qualified designee to call the subject for safety follow\-up.
Exclusion Criteria
- •Subjects having a history of known prior vaccination with a HPV vaccine prior to signing informed consent for participation in this surveillance
- •Subjects who were previously enrolled in HPV vaccine surveillance and received a similar active agent or placebo.
- •Subjects who have received any investigational product within 30 days prior to their first visit.
- •Any condition which in the opinion of the investigator might interfere with the evaluation of the surveillance objectives.
Outcomes
Primary Outcomes
Not specified
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