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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00365378

Purpose

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

Condition	Intervention	Phase
Papillomavirus Infections	Biological: V501 Biological: Comparator : placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	2068
Study Start Date:	October 1998
Study Completion Date:	August 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vaccine	Biological: V501 Duration of Treatment : 6 Months
2: Placebo Comparator Placebo	Biological: Comparator : placebo Duration of Treatment : 6 Months

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365378

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_515, V501-005
Study First Received:	August 16, 2006
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00365378 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

HPV 16 Infection

Additional relevant MeSH terms:

Virus Diseases
Communicable Diseases
Tumor Virus Infections

DNA Virus Infections
Papillomavirus Infections
Infection

ClinicalTrials.gov processed this record on February 08, 2010