Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

Phase 2

Completed

• Conditions: HPV 16 Infection

• Registration Number: NCT00365378
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2004-03
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Study Completion: 2009-07
• Results First Submitted: 2010-03-22
• Results First Submitted QC: 2010-03-22
• Results First Posted: 2010-04-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2409

Inclusion Criteria

• Healthy, unmarried females age 16 to 23 years with intact uteri
• Not pregnant at enrollment
• Agreed to use effective contraception through Month 7 of the study
• A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria

• No prior history of Human Papillomavirus (HPV) vaccination
• No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
• No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Persistent HPV 16 Infection	Through Month 48	Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.
Incidence of HPV 16-related CIN1, CIN2 or C1N3	Through Month 48	Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.
Serum Anti-HPV 16 Geometric Mean Titers	Month 7	The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as "6.0".