None listed
Conditions
Interventions
This trial is open-label
V503† 30/40/60/40/20/20/20/20/20 ug/0.5 mL & HPV Types 6/11/16/18/31/33/45/52/58
1 dose (0.5 mL)
For subjects in Cohort 1, study vaccine will be administered at Month 60.
For subjects in Coho
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
21 Years to 33 Years
Inclusion criteria
Inclusion criteria: Cohort 1 1 Subject enrolled in Part B of V503-001 base study between 16- 26 years, randomized to the 9vHPV vaccine cohort, and in the Per-Protocol Immunogenicity population for at least 1 HPV type 2 Is judged to be in good physical 3 Fully understands study procedures, alternative treatments, risks involved, and voluntarily gives written informed consent. 4 Is able to read, understand, and complete the vaccination report card. 5 Agrees to provide a primary and an alternative telephone number for follow-up purposes. 6 Has not had sex or has had sex with males and used effective contraception with no failures since last menstrual period through month 60 and agrees to use effective contraception for sexual intercourse with males from Month 60 to 61. Cohort 2 1 Subject enrolled in Part A or B of V503-001 base study between 16-26 years, randomized to GARDASIL™ cohort, and received at least 1dose of GARDASIL™. 2 Is judged to be in good physical health. 3 Fully understands study procedures, alternative treatments, risks involved, and voluntarily gives written informed consent. 4 Agrees to provide a primary and an alternative telephone number for follow-up purposes. 5 Has not had sex or has had sex with males and used effective contraception with no failures since last menstrual period through month 60 and agrees to use effective contraception for sexual intercourse with males from Month 60 to 67.
Exclusion criteria
Exclusion criteria: Cohort 1 & 2 1 Has known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ 2 Has a history of severe allergic reaction 3 Has thrombocytopenia or any coagulation disorder 4 Is concurrently enrolled in clinical studies 5 Is pregnant 6 Is currently immunocompromised or diagnosed as having a congenital or acquired immunodeficiency or autoimmune condition. 7 Has had a splenectomy 8 Is receiving immunosuppressive therapies or other therapy known to interfere with the immune response 9 Has or plans to receive any immune globulin product or blood-derived product 10 Has received non-replicating vaccines within 14 days prior to Month 60 or replicating vaccines within 21 days 11 Has received an HPV vaccine outside of V503-001 study 12 Has fever within the 24-hour period prior to Month 60 13 Has a history or current evidence of any that might confound the results of the study, or interfere with the subject’s participation 14 Is unlikely to adhere to the study procedures 15 Is a user of recreational or illicit drugs
Countries
Austria, Brazil, Canada, Chile, China, Colombia, Denmark, Germany, Japan, Korea South, Mexico, New Zealand, Norway, Peru, Sweden, Taiwan, Thailand, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed