Efficacy Against Oral Persistent Infection, Immunogenicity and

Resolution Criteria Trial: NCT04199689 Selected endpoint key: 665f775d03cc2eeaab84347f9b21e1a9626aaaf61c442246fb63989085db9590 Selected endpoint: Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection Endpoint type: other Protocol outcome group: primary Endpoint description: A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart. Endpoint timeframe: Up to Month 90 ClinicalTrials.gov population: Men aged 20-45 years enrolled in V503-049 Market population: Men aged 20-45 years enrolled in V503-049 Analysis set: Not specified in the enumerated ClinicalTrials.gov outcome. Comparison: 9vHPV Vaccine versus placebo (saline for injection) Success direction: lower Success rule: Through Month 90, the incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection must be lower with 9vHPV Vaccine than with placebo in the protocol-specified efficacy analysis set, and the prespecified statistical success criterion must be met. A qualifying infection requires positivity for the same HPV type by PCR to at least 1 common gene in oral-rinse-and-gargle samples from at least 2 consecutive visits 6 months apart, within the specified +/-1-month visit window, after completion of the Month 7 visit. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT04199689?tab=researcher#outcome-measures:~:text=Incidence%20of%20HPV%2016%2F18%2F31%2F33%2F45%2F52%2F58-related%206-month%20Persistent%20Oral%20Infection YES 1. The exact selected endpoint (Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2028-09-30 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2028-09-30T23:59:59Z Deadline evidence: AI web research (confidence 99/100): official source identifies 2028-09-30 as the exact market deadline. Merck's official US Postmarketing Requirements document, current as of January 13, 2026, identifies PMR 1/PMR 125508/868-1 as Study V503-049, describes its efficacy objective as prevention of oral persistent infection with HPV types 16, 18, 31, 33, 45, 52, or 58 in men aged 20-45 years, and states that FDA acknowledged a revised exact final-report-submission due date of September 30, 2028. This exact official deadline is more appropriate for market resolution than the registry's estimated trial-completion dates. Deadline evidence source: https://www.merck.com/wp-content/uploads/sites/124/2026/01/US-Postmarketing-Requirements-Final-13Jan2026.pdf Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.