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
Secondary objectives * To evaluate the tolerability of V503 in 16- to 26-year-old men. * To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
500
Sanofi Pasteur MSD Investigational Site 1002
Ghent, Belgium
Sanofi Pasteur MSD Investigational Site 1003
Leuven, Belgium
Sanofi Pasteur MSD Investigational Site 1001
Wilrijk, Belgium
Sanofi Pasteur MSD Investigational Site 3001
Mainz, Germany
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18
Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.
Time frame: 4 weeks postdose 3 (Month 7)
GMTs to HPV Types 31/33/45/52/58
Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8.
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants With One or More Adverse Events
The percentage of participants with one or more adverse events was assessed.
Time frame: Up to 15 days after any vaccination
Percentage of Participants With Study Discontinuation Due to an Adverse Event
The percentage of participants discontinued from the study due to an adverse event was assessed.
Time frame: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Reactions
The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.
Time frame: Up to 5 days after any vaccination
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Sanofi Pasteur MSD Investigational Site 4001
Amsterdam, Netherlands
Sanofi Pasteur MSD Investigational Site 4003
Amsterdam, Netherlands
Sanofi Pasteur MSD Investigational Site 4002
Nijmegen, Netherlands
Percentage of Participants With Maximum Temperature ≥37.8 °C
The percentage of participants with a maximum temperature ≥37.8 °C was assessed.
Time frame: Up to 5 days after any vaccination
Percentage of Participants With One or More Systemic Adverse Events
The percentage of participants with one or more systemic adverse events was assessed.
Time frame: Up to 15 days after any vaccination
Percentage of Participants With One or More Serious Adverse Events
The percentage of participants with one or more serious adverse events was assessed.
Time frame: Up to 15 days after any vaccination