Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Immunologic Factors

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

V503

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

GARDASIL

Medical Director

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

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

A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men

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.

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.

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.

The percentage of participants with one or more adverse events was assessed.

The percentage of participants discontinued from the study due to an adverse event was assessed.

The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

The percentage of participants with a maximum temperature ≥37.8 °C was assessed.

The percentage of participants with one or more systemic adverse events was assessed.

The percentage of participants with one or more serious adverse events was assessed.

Merck Sharp & Dohme LLC

Total

Age, Continuous

<18 years old

>=18 years old

Age, Customized

Sex: Female, Male

Senior Vice President, Global Clinical Development

HPV Type 6

HPV Type 11

HPV Type 16

HPV Type 18

All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.

Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18

HPV Type 31

HPV Type 33

HPV Type 45

HPV Type 52

HPV Type 58

All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response

GMTs to HPV Types 31/33/45/52/58

Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58

All participants who received at least one study vaccination and had safety follow-up data

Spots Global Cancer Trial Database for A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial