Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00849381 |
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).
Condition | Intervention | Phase |
---|---|---|
Human Papillomavirus (HPV) Type 16/18 Infections and Cervical Neoplasia. |
Biological: GSK580299, GSK Biological's HPV vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment, Safety Study |
Official Title: | Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008. |
Estimated Enrollment: | 1600 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HPV vaccine group: Experimental
Subjects who previously received the Hepatitis A control vaccine in the primary study (NCT00122681) will receive the GSK 580299 HPV vaccine in the current study.
|
Biological: GSK580299, GSK Biological's HPV vaccine
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
|
Ages Eligible for Study: | 26 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Taiwan | |
GSK Investigational Site | Not yet recruiting |
Taipei, Taiwan, 114 | |
GSK Investigational Site | Recruiting |
Taipei, Taiwan, 112 | |
Thailand | |
GSK Investigational Site | Recruiting |
Bangkok, Thailand, 10700 | |
GSK Investigational Site | Recruiting |
Bangkok, Thailand, 10330 | |
GSK Investigational Site | Recruiting |
Bangkok, Thailand, 10400 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111758 |
Study First Received: | February 19, 2009 |
Last Updated: | June 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00849381 History of Changes |
Health Authority: | Brazil: ANVISA; Taiwan: Department of Health; Thailand: Royal Thai Army Medical Department |
HPV cervical cancer papillomavirus human papillomavirus HPV vaccine |