Drug Use Investigation for Cervarix®

GlaxoSmithKline1,230 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,230

Conditions

Infections, Papillomavirus

Interventions

Cervarix®BIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The number of subjects with solicited local adverse events

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

Time frame: 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

Time frame: 7 days after vaccination

The number of subjects with unsolicited adverse events

Any symptoms other than specified (local/systemic) symptoms

Time frame: 30 days after vaccination

The number of subjects with serious adverse events

Time frame: 30 days after vaccination

Data from ClinicalTrials.gov

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