Completed

Study Description:

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 – 14 years in Korea.

GSK Study ID:

104951


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT00290277


EudraCT Number:

2011-004058-24


Study Overview

Medical Conditions

Human Papillomavirus (HPV)

Product

SB580299

Collaborators

N/A


Date

November 2005 to August 2006

Type

Interventional

Phase

3


Gender

Female

Age

10 years - 14 years

Accepts Healthy Volunteers

Yes


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

South Korea, Daegu 700-712Completed
South Korea, Kwangju Completed
South Korea, Seoul 137-701Completed
South Korea, Seoul 135-710Completed
South Korea, Seoul 110-744Completed
South Korea, Seoul 138-736Completed
South Korea, Seoul 133--792Completed
South Korea, Seoul 135-720Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.
    Timeframe: Not Applicable.

Secondary Outcomes:

  • To evaluate safety and reactogenicity throughout the study period.
    Timeframe: Not Applicable.

Interventions:

  • Biological/Vaccine: HPV-16/18 L1/AS04
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 300

Clinical Publications:

  • Kim YJ et al. (2010) Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10–14 years. J Korean Med Sci. 25(8):1197-1204.
  • Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.