Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

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.
 
ClinicalTrials.gov Identifier: NCT00157950
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : September 14, 2010
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Biological: Gardasil™ Biological: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
Study Start Date : October 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Gardasil™
Gardasil™ 3 dose regimen
 Biological: Gardasil™
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
Other Name: V501
Placebo Comparator: Placebo
Gardasil™ matching placebo 3 dose regimen
 Biological: Placebo
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants Who Seroconvert to HPV 6. [ Time Frame: Week 4 Postdose 3 ]
    Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.

  2. Number of Participants Who Seroconvert to HPV 11. [ Time Frame: Week 4 Postdose 3 ]
    Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.

  3. Number of Participants Who Seroconvert to HPV 16. [ Time Frame: Week 4 Postdose 3 ]
    Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.

  4. Number of Participants Who Seroconvert to HPV 18. [ Time Frame: Week 4 Postdose 3 ]
    Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Experiences [ Time Frame: Overall study including 14 calendar days after the last vaccination visit. ]
    Number of participants who reported 1 or more adverse experience.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Girls ages 9 to 15 years (must not yet have had coitarche)
  • Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)

Exclusion Criteria:

All Subjects:

  • History of known prior vaccination with an HPV vaccine.

Women Ages 16 to 23 Only:

  • Individuals with any prior history of genital warts or treatment for genital warts.
  • Individuals with > 3 lifetime male or female sexual partners.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00157950


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157950    
Other Study ID Numbers: V501-023
2005_066
First Posted: September 12, 2005    Key Record Dates
Results First Posted: September 14, 2010
Last Update Posted: February 4, 2016
Last Verified: January 2016
Keywords provided by Merck Sharp & Dohme Corp.:
Human Papilloma Virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections