Adults 16 to 26, any sex, with Genital Warts or Anal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV VaccinePrimary· Four weeks post vaccination 3 (Month 7)
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Anti-HPV Type 6 (n=847, 708, 164)
Group
Value
95% CI
Heterosexual Males
782.0
738.0 – 828.7
Females
703.9
660.6 – 749.9
Men Who Have Sex With Men
568.9
498.7 – 649.0
Anti-HPV Type 11 (n=851, 712, 165)
Group
Value
95% CI
Heterosexual Males
616.7
582.4 – 653.0
Females
564.9
530.6 – 601.3
Men Who Have Sex With Men
437.7
384.4 – 498.5
Anti-HPV Type 16 (n=899, 781, 212)
Group
Value
95% CI
Heterosexual Males
3346.0
3158.9 – 3544.1
Females
2788.3
2621.4 – 2965.8
Men Who Have Sex With Men
2294.0
2037.8 – 2582.5
Anti-HPV Type 18 (n=906, 831, 220)
Group
Value
95% CI
Heterosexual Males
808.2
754.9 – 865.4
Females
679.8
633.1 – 730.1
Men Who Have Sex With Men
608.1
529.4 – 698.5
Anti-HPV Type 31 (n=908, 826, 227)
Group
Value
95% CI
Heterosexual Males
708.5
662.7 – 757.6
Females
570.1
531.5 – 611.5
Men Who Have Sex With Men
420.7
368.0 – 480.9
Anti-HPV Type 33 (n=901, 853, 230)
Group
Value
95% CI
Heterosexual Males
384.8
362.5 – 408.4
Females
322.0
302.9 – 342.3
Men Who Have Sex With Men
252.3
224.2 – 283.8
Anti-HPV Type 45 (n=909, 871, 232)
Group
Value
95% CI
Heterosexual Males
235.6
219.0 – 253.6
Females
185.7
172.3 – 200.2
Men Who Have Sex With Men
157.5
136.2 – 182.2
Anti-HPV Type 52 (n=907, 849, 232)
Group
Value
95% CI
Heterosexual Males
386.8
363.4 – 411.6
Females
335.2
314.3 – 357.6
Men Who Have Sex With Men
233.1
206.0 – 263.7
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report CardPrimary· Up to 5 days after any vaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Overall injection-site AEs
Group
Value
95% CI
Heterosexual and MSM Males
66.7
Females
84.0
Injection-site Erythema
Group
Value
95% CI
Heterosexual and MSM Males
20.7
Females
32.2
Injection-site Pain
Group
Value
95% CI
Heterosexual and MSM Males
63.4
Females
82.5
Injection-site Swelling
Group
Value
95% CI
Heterosexual and MSM Males
20.2
Females
37.5
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)Primary· Up to 5 days after any vaccination
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Group
Value
95% CI
Heterosexual and MSM Males
4.4
Females
5.9
Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV VaccineSecondary· Four weeks post vaccination 3 (Month 7)
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 Types 33, 45, 52, and 58: ≥8.
Anti-HPV Type 6 (n=847, 708, 164)
Group
Value
95% CI
Heterosexual Males
99.6
99.0 – 99.9
Females
99.6
98.8 – 99.9
Men Who Have Sex With Men
99.4
96.6 – 100
Anti-HPV Type 11 (n=851, 712, 165)
Group
Value
95% CI
Heterosexual Males
100
99.6 – 100
Females
99.9
99.2 – 100
Men Who Have Sex With Men
100
97.8 – 100
Anti-HPV Type 16 (n=899, 781, 212)
Group
Value
95% CI
Heterosexual Males
100
99.6 – 100
Females
99.9
99.3 – 100
Men Who Have Sex With Men
100
98.3 – 100
Anti-HPV Type 18 (n=906, 831, 220)
Group
Value
95% CI
Heterosexual Males
99.9
99.4 – 100
Females
99.8
99.1 – 100
Men Who Have Sex With Men
99.5
97.5 – 100
Anti-HPV Type 31 (n=908, 826, 227)
Group
Value
95% CI
Heterosexual Males
100
99.6 – 100
Females
100
99.6 – 100
Men Who Have Sex With Men
100
98.4 – 100
Anti-HPV Type 33 (n=901, 853, 230)
Group
Value
95% CI
Heterosexual Males
100
99.6 – 100
Females
99.9
99.3 – 100
Men Who Have Sex With Men
100
98.4 – 100
Anti-HPV Type 45 (n=909, 871, 232)
Group
Value
95% CI
Heterosexual Males
99.8
99.2 – 100
Females
99.5
98.8 – 99.9
Men Who Have Sex With Men
100
98.4 – 100
Anti-HPV Type 52 (n=907, 849, 232)
Group
Value
95% CI
Heterosexual Males
100
99.6 – 100
Females
99.8
99.2 – 100
Men Who Have Sex With Men
100
98.4 – 100
Percentage of Participants With an Adverse EventPrimary· Up to Month 12
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Group
Value
95% CI
Heterosexual and MSM Males
76.2
Females
89.4
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse EventPrimary· Up to Month 12
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Group
Value
95% CI
Heterosexual and MSM Males
0.1
Females
0.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Month 12.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05119855 — Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Aci
· Phase 3
· completed
NCT05285826 — Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
· Phase 3
· active not recruiting
NCT04313244 — Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vH
· Phase 3
· completed
NCT04199689 — Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHP
· Phase 3
· active not recruiting
Other recruiting trials for Genital Warts
Currently open trials in the same condition.
NCT06866574 — A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Ty
· Phase 3
· active not recruiting
NCT05314023 — Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)
· Phase 3
· active not recruiting
NCT02653118 — Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
· active not recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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· Phase 2
· not yet recruiting
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· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 27 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01651949.