A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

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

Timeline

Start

2014-03-24

Primary completion

2015-04-22

Completion

2015-04-22

Publications

• Results Van Damme P, Meijer CJLM, Kieninger D, Schuyleman A, Thomas S, Luxembourg A, Baudin M. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016 Jul 29;34(35):4205-4212. doi: 10.1016/j.vaccine.2016.06.056. Epub 2016 Jun 25.
• Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. 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. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.

Drugs

Indications