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Sponsored by: |
National Institute for Control of Vaccine and Biologicals |
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Information provided by: | National Institute for Control of Vaccine and Biologicals |
ClinicalTrials.gov Identifier: | NCT00572000 |
The purpose of this study is to assess the occurrence of serious adverse events (SAEs) as well as evaluate the occurrence of solicited local and solicited general symptoms and the occurrence of medically significant conditions reported throughout the study period.
Condition | Intervention |
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Human Papillomavirus (HPV) Vaccine |
Biological: HPV-16/18 L1 VLP AS04 vaccine |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule |
Estimated Enrollment: | 222 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2008 |
Ages Eligible for Study: | 25 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits and for the follow-up visit) should be enrolled in the study.
The female subject should be:
Subjects of childbearing potential (i.e. active menstrual cycle) at the time of study entry:
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and up to one month after the last vaccine dose.
Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period.
Contact: Son Hoa Hoang, Medicine Doctor | 84(4)5595167 | hoanghoason2005@yahoo.com.vn |
Vietnam | |
Thi Son commune health center and Ngoc Son Commune Health Center | Recruiting |
Ha nam, Vietnam, 084 | |
Contact: son hoa hoang, medicine doctor 84(4)5595167 hoanghoason2005@yahoo.com.vn |
Principal Investigator: | Son Hoa Hoang, Medicine Doctor | National Institute for Control of Vaccine and Biologicals |
Principal Investigator: | son hoa hoang, Medicine Doctor | National Institute for Control of Vaccine and Biologicals |
Responsible Party: | National Institute for Control of Vaccine and Biologicals ( National Institute for Control of Vaccine and Biologicals ) |
Study ID Numbers: | 111040 (HPV-022 PRI) |
Study First Received: | December 11, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00572000 |
Health Authority: | Vietnam: Ministry of Health; United States: Federal Government |
Healthy |