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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™


Phase 3
12 Years
26 Years
Not Enrolling
Female
Cervical Cancers, Vulvar Cancers, Vaginal Cancers, Genital Warts

Thank you

Trial Information

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 amendment is to update the definitions of adverse event relationship to study vaccine.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants who experience serious or non-serious adverse events

Outcome Time Frame:

Day 1 to Month 7

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

V503-006

NCT ID:

NCT01047345

Start Date:

February 2010

Completion Date:

November 2011

Related Keywords:

  • Cervical Cancers
  • Vulvar Cancers
  • Vaginal Cancers
  • Genital Warts
  • Cervical cancer
  • Genital warts
  • Human papillomavirus vaccine
  • GARDASIL™
  • Uterine Cervical Neoplasms
  • Condylomata Acuminata
  • Vaginal Neoplasms
  • Vulvar Neoplasms

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