Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Primary Purpose
Papillomavirus Infections
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gardasil™
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Papillomavirus Infections focused on measuring Human Papilloma Virus
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gardasil™
Placebo
Arm Description
Gardasil™ 3 dose regimen
Gardasil™ matching placebo 3 dose regimen
Outcomes
Primary Outcome Measures
Number of Participants Who Seroconvert to HPV 6.
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.
Number of Participants Who Seroconvert to HPV 11.
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.
Number of Participants Who Seroconvert to HPV 16.
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.
Number of Participants Who Seroconvert to HPV 18.
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
Number of Participants With Adverse Experiences
Number of participants who reported 1 or more adverse experience.
Full Information
NCT ID
NCT00157950
First Posted
September 7, 2005
Last Updated
January 7, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00157950
Brief Title
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections
Keywords
Human Papilloma Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gardasil™
Arm Type
Experimental
Arm Description
Gardasil™ 3 dose regimen
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gardasil™ matching placebo 3 dose regimen
Intervention Type
Biological
Intervention Name(s)
Gardasil™
Other Intervention Name(s)
V501
Intervention Description
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Primary Outcome Measure Information:
Title
Number of Participants Who Seroconvert to HPV 6.
Description
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.
Time Frame
Week 4 Postdose 3
Title
Number of Participants Who Seroconvert to HPV 11.
Description
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.
Time Frame
Week 4 Postdose 3
Title
Number of Participants Who Seroconvert to HPV 16.
Description
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.
Time Frame
Week 4 Postdose 3
Title
Number of Participants Who Seroconvert to HPV 18.
Description
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.
Time Frame
Week 4 Postdose 3
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Experiences
Description
Number of participants who reported 1 or more adverse experience.
Time Frame
Overall study including 14 calendar days after the last vaccination visit.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17986242
Citation
Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6.
Results Reference
background
PubMed Identifier
26930146
Citation
Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13.
Results Reference
derived
Learn more about this trial
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
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