A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006 AM1)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01047345
First received: January 11, 2010
Last updated: January 30, 2012
Last verified: January 2012
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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™.
| 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:
Primary Outcome Measures:
- Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 ] [ 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 ] [ Designated as safety issue: No ]
| Enrollment: | 924 |
| Study Start Date: | February 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: V503 Vaccine |
Biological: V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
| Placebo Comparator: Placebo |
Biological: Placebo to V503
Placebo to V503 given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Detailed Description:
This amendment is to update the definitions of adverse event relationship to study vaccine.
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01047345 History of Changes |
| Other Study ID Numbers: | V503-006, 2010_504 |
| Study First Received: | January 11, 2010 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Cervical cancer Genital warts Human papillomavirus vaccine GARDASIL™ |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Condylomata Acuminata Vaginal Neoplasms Vulvar Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Vaginal Diseases Vulvar Diseases |
ClinicalTrials.gov processed this record on June 18, 2013