Phase 3
Completed N=500
A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)
Papilloma Viral Infection
Source: ClinicalTrials.gov NCT02114385 ↗
Enrolled (actual)
500
Serious AEs
1.2%
Results posted
Nov 2018
Primary outcomePrimary: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 — 758.3; 618.4; 681.7; 769.1 milli Merck U/mL — p=<0.001
◆ Published Evidence
Established
81citations · ~8 / year
A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men.
Summary
Primary objective
To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men
Linked Publications (2)
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A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men.
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Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 |
758.3; 618.4; 681.7; 769.1; 3924.1; 3787.9 | <0.001 sig |
| SECONDARY GMTs to HPV Types 31/33/45/52/58 |
794.4; 14.8; 460.5; 3.4; 262.9; 2.5 | — |
| SECONDARY Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 |
98.2; 98.7; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With One or More Adverse Events |
82.3; 81.9 | — |
| SECONDARY Percentage of Participants With Study Discontinuation Due to an Adverse Event |
0; 0 | — |
| SECONDARY Percentage of Participants With One or More Injection-site Adverse Reactions |
79.0; 72.2 | — |
| SECONDARY Percentage of Participants With Maximum Temperature ≥37.8 °C |
2.8; 2.4 | — |
| SECONDARY Percentage of Participants With One or More Systemic Adverse Events |
40.7; 40.3 | — |
| SECONDARY Percentage of Participants With One or More Serious Adverse Events |
0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
- Subject is a man who has had no more than 5 lifetime female sexual partners.
- Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.
Exclusion Criteria
- Subject who has had sex with a male partner.
- Subject has a history of HPV-related external genital lesions or HPV-related anal lesions
- Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE
- Subject has a history of severe allergic reaction that required medical intervention.
- Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Subject is concurrently enrolled in clinical studies of investigational medicinal products.
- 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.
- Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Subject has had a splenectomy.
- 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, TNF-α antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response.
- 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.
- 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.
- Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
- Subject has had a fever within the 24-hour period prior to the Day 1 vaccination.
- 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.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
- Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.
Data sourced from ClinicalTrials.gov (NCT02114385) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.