Health Condition 1: null- Preventative Cervical Cancer
Conditions
Interventions
None listed
Sponsors
MSD Pharmaceuticals PvtLtd
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDr Jamal Baig
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed