A post marketing study to collect safety data of Gardasil when administered in routine practice to females between 9 to 45 years of age

Phase 4

Completed

• Conditions: Health Condition 1: null- Preventative Cervical Cancer

• Registration Number: CTRI/2015/09/006183
• Lead Sponsor: MSD Pharmaceuticals PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is to assess the occurrence of SAEs post Gardasil® administration in female subjects vaccinated under conditions of routine clinical care.Timepoint: The primary outcome of the study is to assess the occurrence of SAEs with in 30 days post Gardasil® administration in female subjects vaccinated under conditions of routine clinical care.

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome is the occurrence of SAEs reported within 30 days of any dose of Gardasil® administered under conditions of routine clinical care.Timepoint: The Secondary outcome is the occurrence of SAEs reported within 30 days of any dose of Gardasil® administered under conditions of routine clinical care.