A RANDOMIZED, INTERNATIONAL, DOUBLE-BLINDED (WITH IN-HOUSE BLINDING), CONTROLLED WITH GARDASIL™, DOSE-RANGING, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY STUDY OF A MULTIVALENT HUMAN PAPILLOMAVIRUS (HPV) L1 VIRUS-LIKE PARTICLE (VLP) VACCINE ADMINISTERED TO 16- TO 26-YEAR-OLD WOME

Not Applicable

• Conditions: -B977 Papillomavirus as the cause of diseases classified to other chapters; Papillomavirus as the cause of diseases classified to other chapters; B977

• Registration Number: PER-090-13
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 230

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified