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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:
ClinicalTrials.gov Identifier:
NCT00365378
First Posted: August 17, 2006
Last Update Posted: October 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Condition Intervention Phase
HPV 16 Infection Biological: Comparator: HPV 16 L1 Vaccine Biological: Comparator: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of Persistent HPV 16 Infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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".


Enrollment: 2409
Study Start Date: September 1999
Study Completion Date: July 2009
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HPV 16 L1 VLP vaccine
Biological: Comparator: HPV 16 L1 Vaccine
A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
Other Name: V501
Placebo Comparator: 2
Placebo
Biological: Comparator: Placebo
A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365378


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00365378     History of Changes
Other Study ID Numbers: V501-005
2006_515
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: March 22, 2010
Results First Posted: April 9, 2010
Last Update Posted: October 23, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs