Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice

N/AUnknownNCT03659110

Beijing Chaoyang District Centre for Disease Control and Prevention1,000 enrolled

Overview

This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Cervical Cancer

Interventions

HPV 4BIOLOGICAL

1000 subjects will be received the HPV 4 vaccine

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening Exclusion Criteria: 1. Unable to provide written informed consent 2. Any woman who is known being pregnant at screening 3. Subject who is participating or going to participate in another study which involves GARDASIL administration

Outcomes

Primary Outcomes

Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice

Adverse reactions associated with vaccine will be observed in females Aged 20-45 Years after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

Time frame: 24 months

Number of participants with adverse events following any dose of vaccine

Time frame: within 30 days after each dose

Data from ClinicalTrials.gov

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