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

Papillomavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157950
• Other study ID #: V501-023
• Secondary ID: 2005_066
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: January 7, 2016
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 23 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

Biological:
• Gardasil™
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
• Placebo
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. Epub 2007 Nov 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4 Postdose 3	No
Primary	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.	Week 4 Postdose 3	No
Primary	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.	Week 4 Postdose 3	No
Primary	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.	Week 4 Postdose 3	No
Secondary	Number of Participants With Adverse Experiences	Number of participants who reported 1 or more adverse experience.	Overall study including 14 calendar days after the last vaccination visit.	No