A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
9 Years
26 Years
Both
Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions, PAP Test Abnormalities, HPV Infections
Trial Information
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
The base study V503-002 is a 12-month study that is collecting safety and immunogenicity
information for six months following the subjects' third dose of study vaccine and is
expected to conclude in 2011.
An optional extension study (V503-002 EXT1) will collect safety and immunogenicity
information through Month 36. No study vaccine will be administered in the extension study.
Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in
EXT1.
An optional second extension study (V503-002 EXT2) will collect long-term safety and
immunogenicity information through approximately 10 years. No study vaccine will be
administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in
the base study will not be included in EXT2.
Inclusion Criteria:
Boys and Girls Age 9 to 15:
- Participant has not had sexual intercourse prior to the study and does not plan to
become sexually active during the study period Day 1 to Month 7
Women Age 16 to 26:
- Participant has never had Pap testing or has had only normal results
- Participant has had 0 to 4 sexual partners at the time of enrollment
Exclusion Criteria:
Boys and Girls Age 9 to 15:
- History of allergic reaction that required medical intervention
- Currently enrolled in any other clinical study
- Participant is pregnant
- Participant is immunocompromised or has taken immunosuppressants in the last year
- Participant has received a marketed HPV vaccine or participated in an HPV vaccine
clinical trial
- Participant has a history of positive test for HPV
Women Age 16 to 26:
- History of allergic reaction that required medical intervention
- Currently enrolled in any other clinical study
- Participant is pregnant
- Participant is immunocompromised or has taken immunosuppressants in the last year
- Participant has received a marketed HPV vaccine or participated in an HPV vaccine
clinical trial
- Participant has a history of positive test for HPV
- Participant has a history of abnormal cervical biopsy result
- Participant has a history of external genital lesions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of subjects with injection site adverse experiences
Outcome Time Frame:
Day 1 to 5 post-vaccination
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
V503-002
NCT ID:
NCT00943722
Start Date:
August 2009
Completion Date:
June 2020
Related Keywords:
- Cervical Cancers
- Vulvar Cancer
- Vaginal Cancer
- Genital Lesions
- PAP Test Abnormalities
- HPV Infections
- Congenital Abnormalities
- Uterine Cervical Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
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