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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00799825 |
Purpose
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 580299/008 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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008 |
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HPV vaccine group
Canadian and American 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 40 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00799825 History of Changes |
| Other Study ID Numbers: | 111955 |
| Study First Received: | November 26, 2008 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
papillomavirus HPV vaccine cervical cancer HPV human papillomavirus |