A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds)

• Register: EUCTR
• Last refreshed on: 28 January 2013
• Main ID: EUCTR2010-023393-39-DK
• Date of registration: 21/01/2011
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD S.N.C
• Public title: A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds)
• Scientific title: A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds)
• Date of first enrolment: 26/01/2011
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023393-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Denmark, Finland, Italy, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
To be randomized and receive the first study vaccination, subjects must meet all inclusion criteria.
1. Subject is a female, between the ages of 9 years and 0 days and 15 years and 364 days on the day of enrolment.
2. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
3. Subject and parent/legal guardian 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. Subject must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period.

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:
To be randomized and receive the first study vaccination, subjects must not meet any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
1. Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE® (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event.
2. 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.
3. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
4. Subject is concurrently enrolled in clinical studies of investigational medicinal products.
5. Subject is pregnant (as determined by a urine pregnancy test provided by the sponsor).
6. *Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
7. 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.
8. Subject has had a splenectomy.
9. Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava®), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Mabthera®]), 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 she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrolment) 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 enrolment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
10. Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
11. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
12. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
13. *Subject has had a fever (defined as an oral temperature of =37.8°C) within the 24-hour period prior to the Day 1 vaccination.
14. Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
15. Subject is unlikely to adhere to the stu

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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.
MedDRA version: 12.1 Level: LLT Classification code 10066416 Term: Vulvovaginal human papilloma virus infection

Intervention(s)

Product Name: 9-Valent Human Papillomavirus[HPV] L1 Virus-Like Particle [VPL] Vaccine
Product Code: V503
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HPV type 6 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: HPV type 11 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: HPV type 16 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 60-
INN or Proposed INN: HPV type 18 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: HPV type 31 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: HPV type 33 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: HPV type 45 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: HPV type 52 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: HPV type 58 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: GARDASIL
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HPV type 6 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: HPV type 11 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: HPV type 16 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: HPV type 18 L1 protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To demonstrate that administration of the 9-valent HPV L1 VLP vaccine induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 16 and anti-HPV 18 compared to GARDASIL® in preadolescent and adolescent girls 9 to 15 years of age.

Primary end point(s): The primary immunogenicity endpoints are the cLIA geometric mean titers (GMTs) to HPV 16 and 18 at 4 weeks post dose 3.

Secondary Objective: To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine in preadolescent and adolescent girls 9 to 15 years of age.
To summarise humoral immune responses (including anti-HPV 6, 11, 16, 18, GMTs and seroconversion rates at Day 1 and at 4 weeks post-dose 3) in preadolescent and adolescent girls 9 to 15 years of age who received 9-valent HPV L1 VLP vaccine or GARDASIL®.

Secondary ID(s)

2010-023393-39-FI

GDS01C