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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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00365378
First received: August 16, 2006
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Primary Outcome Measures:
  • 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".


Enrollment: 2409
Study Start Date: October 1998
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

Ages Eligible for Study:   16 Years to 23 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365378

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00365378     History of Changes
Other Study ID Numbers: 2006_515, V501-005
Study First Received: August 16, 2006
Results First Received: March 22, 2010
Last Updated: April 20, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013