Trials / Completed
CompletedNCT01101542
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,091 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 10 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cervarix. | Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings. |
| OTHER | Data collection | All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2014-02-20
- Completion
- 2014-02-20
- First posted
- 2010-04-12
- Last updated
- 2018-07-23
- Results posted
- 2011-12-19
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01101542. Inclusion in this directory is not an endorsement.