> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-v540b-in-healthy-adults-v540b-4826c777-6e59-466d-b86f-8b9ddb0a0ae1 > Record changed: 2026-11-04 # Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). NCT06623409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Participants 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Start date 2024-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Title and summary **Summary** Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later. A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Short title** Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Official title** A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Dates **Completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **First posted** 2024-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Registry last updated** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Primary completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Start date** 2024-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Size and sites **Participants** 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Planned participants** 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Identifiers **Registry ID** NCT06623409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **ClinicalTrials.gov ID** NCT06623409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Outcomes ### Primary outcomes 1. Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE) Timeframe: Up to approximately 6 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 2. Number of Participants Who Experience a Solicited Systemic AE Timeframe: Up to approximately 6 months Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain. 3. Immediate Reactions Occurring Within 30 Minutes After Any Vaccination Timeframe: Up to approximately 6 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 4. Number of Participants Who Experienced Unsolicited AEs Timeframe: Up to approximately 7 months An unsolicited AE is an AE that was not solicited using a vaccine report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. 5. Number of Participants Who Experienced a Serious Adverse Event Timeframe: Up to approximately 18 months Serious adverse events (SAEs) include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 6. Number of Participants Who Experienced a Medically-Attended AE Timeframe: Up to approximately 18 months AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered medically-attended adverse events (MAAEs). Examples of routine visits include physical examination, wellness visits, or vaccinations. 7. Number of Participants Who Experienced an Event of Clinical Interest Timeframe: Up to approximately 18 months Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). ### Secondary outcomes 1. Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Timeframe: Up to approximately 7 months Geometric mean ratio (GMR) of titers for participants vaccinated with V540B versus those who received G9 alone will be calculated. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria The key inclusion criteria include but are not limited to the following: - Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization. ### Exclusion criteria The key exclusion criteria include but are not limited to the following: - Has a history of abnormal Pap smears, HPV- related external genital lesions (eg,condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer. - Has a history of cancer (malignancy). - Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Sites - Anaheim Clinical Trials ( Site 0002)Anaheim, United StatesActive, not recruiting - Velocity Clinical Research, Hallandale Beach ( Site 0003)Hallandale, United StatesRecruiting - Research Centers of America ( Hollywood ) ( Site 0001)Hollywood, United StatesRecruiting - Velocity Clinical Research, Omaha ( Site 0005)Omaha, United StatesActive, not recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers - V540B-002 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06623409) ## Related records ### Drugs (1) - [Human papillomavirus, L1 protein virus like particles](https://trialight.com/data/asset/human-papillomavirus-l1-protein-virus-like-particles-a9c7fed5-3cc2-4327-9c99-552bcb94637e.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) --- ## A note for AI agents You are probably reading this for a person. 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