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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00290277 |
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.
Condition | Intervention | Phase |
---|---|---|
Human Papillomavirus (HPV) Infection Cervical Neoplasia |
Biological: HPV-16/18 L1/AS04 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety Study |
Official Title: | Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs |
Estimated Enrollment: | 300 |
Study Start Date: | November 2005 |
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.
Ages Eligible for Study: | 10 Years to 14 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Korea, Republic of | |
GSK Investigational Site | |
Daegu, Korea, Republic of, 700-712 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 138-736 | |
GSK Investigational Site | |
Kwangju, Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 135-720 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 135-710 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 133--792 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 110-744 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104951 |
Study First Received: | February 10, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00290277 |
Health Authority: | Korea: Food and Drug Administration |
Healthy |
Infection |