An International Study of an HPV Vaccine in 16- to 26-Year-Old Wome

• Conditions: Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58.; MedDRA version: 17.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2007-003528-39-SE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-21
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 14620

Inclusion Criteria

1.Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of randomization.
2.Subject has never had Pap testing or has only had normal Pap test results.
3.The subject has the following lifetime sexual history at the time of enrollment:
a)Subject has had 1 to 4 male and/or female sexual partners; or
b)Subject has had 0 male and/or female sexual partners, is 18 years of age or older, and plans to become sexually active within the first 3 months of the study.
4.Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).

Are the trial subjects under 18? yes
Number of subjects for this age range: 2658
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11962
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
2.Subject has a history of a positive test for HPV.
3.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
4.Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
5.Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified