NCT03659110

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2.8 years

First QC Date

September 3, 2018

Last Update Submit

September 25, 2018

Conditions

Cervical Cancer

Keywords

vaccinesafety

Outcome Measures

Primary Outcomes (2)

  • 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

    24 months

  • Number of participants with adverse events following any dose of vaccine

    Number of participants with adverse events following any dose of vaccine

    within 30 days after each dose

Study Arms (1)

1000 subjects receive the HPV 4 vaccine

Biological: HPV 4

Interventions

HPV 4BIOLOGICAL

1000 subjects will be received the HPV 4 vaccine

1000 subjects receive the HPV 4 vaccine

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers aged 20-45 years

You may qualify if:

  • Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening

You may not qualify if:

  • Unable to provide written informed consent
  • Any woman who is known being pregnant at screening
  • Subject who is participating or going to participate in another study which involves GARDASIL administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 6, 2018

Study Start

October 1, 2018

Primary Completion

July 30, 2021

Study Completion

December 30, 2021

Last Updated

September 27, 2018

Record last verified: 2018-09