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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00365378
First received: August 16, 2006
Last updated: November 3, 2014
Last verified: November 2014

August 16, 2006
November 3, 2014
September 1999
March 2004   (final data collection date for primary outcome measure)
  • Incidence of Persistent HPV 16 Infection [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    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".
Safety and tolerability
Complete list of historical versions of study NCT00365378 on ClinicalTrials.gov Archive Site
Not Provided
Through 42 months: HPV 16 PCR Positivity; serum anti-HPV 16 levels; incidence of CIN 1, 2, and 3
Not Provided
Not Provided
 
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HPV 16 Infection
  • Biological: Comparator: HPV 16 L1 Vaccine
    A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
    Other Name: V501
  • Biological: Comparator: Placebo
    A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
  • Experimental: 1
    HPV 16 L1 VLP vaccine
    Intervention: Biological: Comparator: HPV 16 L1 Vaccine
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2409
July 2009
March 2004   (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 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)
Female
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00365378
V501-005, 2006_515
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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