Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Conditions
Interventions
Product Name: Nonavalent HPV VLP Vaccine
Product Code: N/A
Pharmaceutical Form: Suspension for injection
Current Sponsor code: V503
Concentration unit: µg microgram(s)
Concentration type: equal
Concen
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, between the ages of 11 years and 0 days and 15 years and 364 days on the day of enrollment. 2. Subject is judged to be in good physical health on the basis of medical history and physical examination. 3. Parent/legal guardian and subject fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent/assent. 4. Parent/legal guardian is able to read, understand, and complete the vaccination report card. 5. Subject and parent/legal guardian agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes. 6. Subject must not yet have had coitarche and does not plan on becoming sexually active through the course of the study. 7. Subject must have previously received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5 year interval to a prior vaccination containing any one of these vaccine antigens. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 has a known allergy to any vaccine component of the 9-valent HPV L1 VLP vaccine, REPEVAX™ or residues carried over from manufacture (such as formaldehyde, glutaraldehyde, streptomycin, neomycin, and polymoxin B). Individuals allergic to aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). Subject experienced an allergy to a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine. 2. Subject has had a severe reaction affecting the brain (e.g. evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine. 3. Subject has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine. 4. Subject ever had Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the body) or brachial neuritis (loss of movement, pain and numbness of the arm and the shoulder) following a previous dose of a tetanus containing vaccine. 5. Subject has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™. 6. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention. 7. Subject has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections. 8. Subject is concurrently enrolled in clinical studies of investigational agents. 9. (Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG). 10. 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. 11. Subject has had a splenectomy. 12. Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he/she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using inhaled, nasal, topical, or ocular steroids are considered eligible for the study. 13. Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during the study. 14. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To demonstrate that a first dose of the 9-valent HPV L1 VLP vaccine administered concomitantly with REPEVAX™ induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 ;Main Objective: Tolerability of the concomitant administration of a first dose of the 9-valent HPV L1 VLP vaccine with REPEVAX™ in preadolescent and adolescent boys and girls11-15 years of age. Immunogenicity Objectives: 1) To demonstrate that a first dose of the 9-valent HPV L1 VLP vaccine administered concomitantly with REPEVAX™ induces non-inferior anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 Geometric Mean Titers (GMTs) in preadolescent and adolescent boys and girls 11 to 15 years of age compared to the administration of the 9-valent HPV L1 VLP vaccine separately. 2) To demonstrate that REPEVAX™ administered concomitantly with a first dose of the 9-valent HPV L1 VLP vaccine induces non-inferior immune responses to diphtheria, tetanus, poliovirus types 1,2,and 3, and pertussis in preadolescent and boys and girls 11 to 15 years of age compared to the administration of REPEVAX™ separately.;Primary end point(s): Immunogenicity: The primary immunogenicity endpoints for evaluating antibody response to 9-valent HPV L1 VLP vaccine are geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Week 4 Postdose 3. The primary immunogenicity endpoints for evaluating antibody response to the diphtheria and tetanus components of REPEVAX™ are the proportions of subjects who achieve antibody titers of at least 0.1 IU/mL one month postvaccination of REPEVAX™, where this is assessed by the Micrometabolic Inhibition Test for diphtheria and by EIA for tetanus. The primary immunogenicity endpoints for pertussis are the GMTs to anti-PT, anti-FHA, anti-FIM and anti-PRN one month postvaccination of REPEVAX™. The primary immunogenicity endpoints for evaluating antibody response to the polio component of | — |
Countries
Austria, Belgium, Denmark, Finland, Germany
Outcome results
None listed