Cervical Cancer
Conditions
Interventions
Product Name: Nonavalent HPV VLP Vaccine
Product Code: V503
Pharmaceutical Form: Suspension for injection
Current Sponsor code: V503
Concentration unit: µg microgram(s)
Concentration type: equal
Conce
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, between the ages of 9 years and 0 days and 15 years and 364 days on the day of enrolment, or the subject is female between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment. 2. Subjects age 9-15 must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period. 3. Subjects age 16-26 have a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. 4. Subject has never had Pap testing or has only had normal Pap test results. 5. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG). 2. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. 3. Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens. 4. Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). 5. Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition. 6. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse). 7. Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and Immunogenicity and Manufacturing Consistency;Secondary Objective: Adolescent-Adult Immunobridging Study;Primary end point(s): Safety: To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine in preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 y/o. Immunogenicity: The primary immunogenicity endpoints are cLIA geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 weeks post dose 3. Manufacturing Lot Consistency: To demonstrate that the Final Manufacturing Process (FMP) results in 9-valent HPV L1 VLP vaccine that induces consistent serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 responses. | — |
Countries
Austria, Belgium, Finland, Spain, Sweden
Outcome results
None listed