A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01047345
First received: January 11, 2010
Last updated: February 4, 2014
Last verified: February 2014

January 11, 2010
February 4, 2014
February 2010
June 2011   (final data collection date for primary outcome measure)
Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 of the Base Study ] [ Designated as safety issue: Yes ]
Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01047345 on ClinicalTrials.gov Archive Site
Number of participants who are seropositive to each of the HPV types contained in V503 [ Time Frame: Month 7 of the Base Study ] [ Designated as safety issue: No ]
Number of participants who are seropositive to each of the HPV types contained in V503 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
Number of participants who experience serious adverse events [ Time Frame: Day 1 to Month 7 of the Extension Study ] [ Designated as safety issue: Yes ]
Not Provided
 
A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

This study will evaluate whether V503, a multivalent HPV vaccine, is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with V503 or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with V503 on Day 1, Month 2, and Month 6 of the Extension Study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Cancers
  • Vulvar Cancers
  • Vaginal Cancers
  • Genital Warts
  • Biological: V503
    V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study and the Study Extension
  • Biological: Placebo to V503
    Placebo to V503 given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
  • Experimental: V503 Vaccine
    V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
    Intervention: Biological: V503
  • Placebo Comparator: Placebo
    Placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
    Interventions:
    • Biological: V503
    • Biological: Placebo to V503
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
924
March 2015
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Participants Age 12 to 15 Years:

  • Participant is in good health
  • Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  • Participant has not received any other HPV vaccine
  • Participant is not yet sexually active

Participants Age 16 to 26 Years:

  • Participant is in good health
  • Participant agrees to provide a primary telephone number for follow-up
  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
  • Participant has not received any other HPV vaccine
  • Participant has never had Pap testing or has only had normal results
  • Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria:

All participants:

  • Participant has a history of severe allergic reaction that required medical intervention
  • Participant has any disorder that would contraindicate intramuscular injections
  • Participant is pregnant
  • Participant is immunocompromised or has an autoimmune condition
  • Participant has had a splenectomy
  • Participant has received any immune globulin product or blood-derived product
  • Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

  • Participant expects to donate eggs during the study
  • Participant has a history of abnormal cervical biopsy result
  • Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer
Female
12 Years to 26 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01047345
V503-006, 2010_504
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP