Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00485732 |
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
---|---|---|
Human Papillomavirus (HPV) Infection Associated Cervical Neoplasia |
Biological: HPV-16/18 L1 VLP AS04 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIIb, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years. |
Estimated Enrollment: | 225 |
Study Start Date: | June 2007 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 138-736 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 150-879 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 137-040 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 158-710 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 110-744 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 120-752 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 107291 |
Study First Received: | June 12, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00485732 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Phase IIIb Double-blind Randomized Controlled HPV |
HPV-16/18 L1 VLP AS04 AS04 Cervical cancer Cervical neoplasia Korea |
Healthy |
Infection |