Drug Use Investigation for Cervarix®

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01187927

Enrollment

1230

Registered

2010-08-24

Start date

2010-09-30

Completion date

2014-01-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Papillomavirus

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.

Interventions

BIOLOGICALCervarix®

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

10 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
The number of subjects with solicited local adverse events	7 days after vaccination	Local adverse events: pain, redness, swelling at the vaccination site
The number of subjects with solicited general adverse events	7 days after vaccination	General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash
The number of subjects with unsolicited adverse events	30 days after vaccination	Any symptoms other than specified (local/systemic) symptoms
The number of subjects with serious adverse events	30 days after vaccination	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026