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
  Purpose

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.


Condition Intervention Phase
Cervical Cancers
Vulvar Cancers
Vaginal Cancers
Genital Warts
Biological: V503
Biological: Placebo to V503
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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™

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Number of participants who experience serious adverse events [ Time Frame: Day 1 to Month 7 of the Extension Study ] [ Designated as safety issue: Yes ]

Enrollment: 924
Study Start Date: February 2010
Estimated Study Completion Date: March 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   12 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01047345     History of Changes
Other Study ID Numbers: V503-006, 2010_504
Study First Received: January 11, 2010
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Cervical cancer
Genital warts
Human papillomavirus vaccine
GARDASIL™

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Tumor Virus Infections
Vulvar Diseases
Condylomata Acuminata
Warts
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on August 27, 2014