Not Signed In -
Marburg virus |
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Clinical Trial: HPV Registration Study
This study is not yet open for patient recruitment.
Verified by Merck September 2005
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Purpose
An Immunogenicity and Safety Study of V501 in females 9 to 23 years of age in Korea.
| Condition | Intervention | Phase |
|---|---|---|
| Human Papilloma Virus | Vaccine: V501 | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Immunogenicity and Safety Study of V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) in Females 9 to 23 Years of Age in Korea
Further Study Details:
Primary Outcomes: Immunogenicity
Secondary Outcomes: Safety
Expected Total Enrollment: 171
Secondary Outcomes: Safety
Expected Total Enrollment: 171
Study start: October 2005
Eligibility
Ages Eligible for Study: 9 Years - 23 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Girls Age 9 to 15 Years (Must not yet have had coitarche)
- Healthy females age 16 to 23 years.(Individuals with a lifetime history of 0 to 3 male or female sexual partners)
Exclusion Criteria:
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Exclusion Criteria (All Subjects)
a. History of known prior vaccination with an HPV vaccine.
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Exclusion Criteria: Women Age 16 to 23 Only
- Individuals with any prior history of genital warts or treatment for genital warts.
- Individuals with >3 lifetime male or female sexual partners.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00157950
Korea, Republic of
MSD Korea Ltd., Seoul, 121-705, Korea, Republic of
Paul Jang, Dr. 822-8383-0024
Study chairs or principal investigators
Medical Monitor, Study Director, Merck
More Information
Study ID Numbers: 2005_066
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00157950
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00157950
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Arenaviruses (MayoClinic)
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