NCT01187927

Brief Summary

This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Status
completed

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

August 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

August 20, 2010

Last Update Submit

January 22, 2015

Conditions

Infections, Papillomavirus

Outcome Measures

Primary Outcomes (4)

  • The number of subjects with solicited local adverse events

    Local adverse events: pain, redness, swelling at the vaccination site

    7 days after vaccination

  • The number of subjects with solicited general adverse events

    General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash

    7 days after vaccination

  • The number of subjects with unsolicited adverse events

    Any symptoms other than specified (local/systemic) symptoms

    30 days after vaccination

  • The number of subjects with serious adverse events

    30 days after vaccination

Study Arms (1)

Female subjects

Subjects received Cervarix® as per routine practice

Biological: Cervarix®

Interventions

Cervarix®BIOLOGICAL

Administered according to the prescribing information in the locally approved label by the authorities.

Female subjects

Eligibility Criteria

Age10 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese women who received Cervarix® for the first time

You may qualify if:

  • Subject must be female
  • Subject must be aged 10 and over

You may not qualify if:

  • Subject with obvious fever
  • Subject with obvious severe acute disease
  • Subject with hypersensitivity to any component of Cervarix®
  • Other than above, subject who is in inappropriate conditions for vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 24, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01