None listed
Conditions
Interventions
Product Name: Nonavalent HPV VLP Vaccine
Pharmaceutical Form: Suspension for injection
Current Sponsor code: V503
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 27
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is a female, between the ages of 12 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. 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/assent. 3. Subject has received a 3-dose regimen of marketed GARDASILTM within a 1 year period as confirmed by medical or vaccination records including dates of administration. 4. Subject has received the third dose of GARDASILTM at least 1 year prior to Day 1. 5. Subjects age 12-15 years must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period. 6. Subjects age 16-26 have a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. 7. Subject has never had Pap testing or has only had normal Pap test results. 8. 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 participated in a HPV vaccine clinical trial (whether receiving active agent or placebo). 5. 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]). 6. 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. 7. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse). Subject has a history 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 in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASIL™.;Secondary Objective: Demonstrate that the 9-valent HPV L1 VLP vaccine is immunogenic with respect to HPV Types 31, 33, 45, 52, and 58 in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASIL™. ;Primary end point(s): Safety: To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine in adolescent girls 12 to 15 years of age and young women 16 to 26 y/o who have previously received GARDASIL. Immunogenicity: The primary immunogenicity endpoints is the percentage of seropositivity to HPV 31, 33, 45, 52, and 58 at 4 weeks post dose 3. Other immunogenicity endpoints are geometric mean titers (GMTs) to HPV 31, 33, 45, 52, and 58 at 4 weeks post dose 3, GMTs and percentage of seropositivity to HPV 6, 11, 16, and 18 at 4 weeks post dose 3. | — |
Countries
Denmark, Sweden
Contacts
Public ContactClinical Project Manager
Merck Sharp & Dohme (Sweden) AB
Outcome results
None listed