Study of HPV 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females - Tabular View

Tracking Information

First Received Date ^ICMJE

August 16, 2006

Last Updated Date

August 18, 2009

Start Date ^ICMJE

October 1998

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: Through 42 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety and tolerability

Change History

Complete list of historical versions of study NCT00365378 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HPV 16 PCR Positivity; serum anti-HPV 16 levels; incidence of CIN 1, 2, and 3 [ Time Frame: Through 42 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Through 42 months: HPV 16 PCR Positivity; serum anti-HPV 16 levels; incidence of CIN 1, 2, and 3

Descriptive Information

Brief Title ^ICMJE

Study of HPV 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

Official Title ^ICMJE

Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Papillomavirus Infections

Intervention ^ICMJE

Biological: V501
Biological: Comparator : placebo

Study Arms / Comparison Groups

Experimental: Vaccine
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2068

Completion Date

August 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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 Pap test showing SIL or biopsy showing CIN

Gender

Female

Ages

16 Years to 23 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00365378

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2006_515, V501-005

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP