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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00316706 |
This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA).The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).
The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of 580299-013. During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the 580299-013 study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Papillomavirus Infections Cervical Intraepithelial Neoplasia |
Biological: HPV-16/18 L1/AS04 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013 |
Estimated Enrollment: | 1400 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 10 Years to 14 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Colombia | |
Bogota, Colombia | |
Germany | |
Berlin, Germany | |
Honduras | |
Tegucigalpa, Honduras | |
Panama | |
Panama City, Panama | |
Taiwan | |
Taipei, Taiwan |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 104896 (month 18 FU), 104902 (month 24 FU), 104904 (month 36 FU), 104918 (month 48 FU) |
Study First Received: | April 19, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00316706 |
Health Authority: | United States: Food and Drug Administration |
Prophylaxis HPV-16/18 infections and cervical neoplasia |
Virus Diseases Cervical intraepithelial neoplasia Carcinoma in Situ DNA Virus Infections Papillomavirus Infections |
Healthy Papilloma Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Infection |