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

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ClinicalTrials.gov Identifier: NCT03659110
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing Chaoyang District Centre for Disease Control and Prevention

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

Condition or disease Intervention/treatment
Cervical Cancer Biological: HPV 4

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : December 30, 2021

Group/Cohort Intervention/treatment
1000 subjects receive the HPV 4 vaccine Biological: HPV 4
1000 subjects will be received the HPV 4 vaccine




Primary Outcome Measures :
  1. Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice [ Time Frame: 24 months ]
    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

  2. Number of participants with adverse events following any dose of vaccine [ Time Frame: within 30 days after each dose ]
    Number of participants with adverse events following any dose of vaccine



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Volunteers aged 20-45 years
Criteria

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

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Responsible Party: Beijing Chaoyang District Centre for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03659110     History of Changes
Other Study ID Numbers: cycdc2018-1
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Chaoyang District Centre for Disease Control and Prevention:
vaccine
safety
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs