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Study of HPV 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
This study has been completed.
Study NCT00365378   Information provided by Merck
First Received: August 16, 2006   Last Updated: August 18, 2009   History of Changes

August 16, 2006
August 18, 2009
October 1998
July 2009   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: Through 42 months ] [ Designated as safety issue: Yes ]
Safety and tolerability
Complete list of historical versions of study NCT00365378 on ClinicalTrials.gov Archive Site
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 ]
Through 42 months: HPV 16 PCR Positivity; serum anti-HPV 16 levels; incidence of CIN 1, 2, and 3
 
Study of HPV 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
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

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

 
Phase II
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Papillomavirus Infections
  • Biological: V501
  • Biological: Comparator : placebo
  • Experimental: Vaccine
  • Placebo Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
2068
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Female
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00365378
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
2006_515, V501-005
Merck
 
Study Director: Medical Monitor Merck
Merck
August 2009

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