Clinical Trials List
Protocol NumberV540A-005
Not yet recruiting
2025-09-01 - 2029-12-31
Phase II
Recruiting6
ICD-10B97.7
Papillomavirus as the cause of diseases classified elsewhere
ICD-9079.4
Human papilloma virus infections in conditions classified elsewhere and of unspecified site
A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
Merck Sharp & Dohme LLC
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 呂其融 Division of Infectious Disease
- 梁智瑋 Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Po-Liang Lu Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yhu-Chering Huang Division of Pediatrics
- Chi-Long Chen Division of Pediatrics
- MING-HAN TSAI Division of Pediatrics
- 謝育嘉 Division of Pediatrics
- 郭貞孍 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉芝谷 Division of Obstetrics & Gynecology
- Chien-Hsing Lu Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
MING-CHE LIU
Co-Principal Investigator
- 黃建榮 Division of Urology
- CHIEN-CHIH WU Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Healthy Females
Objectives
To evaluate the safety and
tolerability of 3-dose regimens of V540A.
Test Drug
Injection
Active Ingredient
Human Papillomavirus 14-valent Vaccine, Recombinant
Human Papillomavirus 9-valent Vaccine, Recombinant
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage Form
270
270
270
Dosage
1064 μg/mL (0.5mL/vial)
0.5 mL/vial
0.5 mL/vial
Endpoints
• Solicited injection-site AEs from Day 1
through Day 5 post each vaccination
Solicited pyrexia from Day 1 through
Day 5 post each vaccination
Vaccine-related SAEs from Day 1
through the duration of participation in
the study
through Day 5 post each vaccination
Solicited pyrexia from Day 1 through
Day 5 post each vaccination
Vaccine-related SAEs from Day 1
through the duration of participation in
the study
Inclution Criteria
An individual is eligible for inclusion in the study if the individual meets all of the following
criteria:
Type of Participant and Disease Characteristics
1. Is in good health based on medical history and physical examination according to the
clinical judgment of the investigator.
Demographics
2. Is assigned female sex at birth, from 16 years to 26 years of age inclusive, at the time of
providing the informed consent or assent, as applicable.
Follow local regulatory requirements if the legal age of consent for participation is >18
years of age.
Assigned Female Sex at Birth
3. A participant assigned female sex at birth is eligible to participate if not breastfeeding
during the study intervention period and for at least 30 days after the last dose of study
intervention.
4. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive
pregnancy test (urine or serum), as required by local regulations, has been obtained
within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of
study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous
result), a serum pregnancy test is required. Additional requirements for pregnancy testing
during and after study intervention are in Section 8.3.3.
5. A POCBP is eligible to participate if they use a contraceptive method that is highly
effective (with a failure rate of <1% per year), or if they adhere to penile-vaginal
intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and
persistent basis), as described in Appendix 5, during the intervention period and for at
least the time needed to eliminate each study intervention after the last dose of study
intervention. The length of time required to continue contraception for the study
intervention is: 7 months
Informed Consent
6. The participant (or legally acceptable representative) has provided documented informed
consent and the participant has provided documented assent, when applicable, for the
study.
Additional Categories
7. Agrees to provide study personnel with a primary telephone number as well as an
alternate form of contact, if available, for follow-up purposes.
8. Has a lifetime history of 0 to 4 sexual partners of any sex/gender at the time of
enrollment. Sexual partner is defined as an individual with whom the participant has had
penile penetrative sexual intercourse or has contacted the participant’s genitalia during
sexual activity, defined as having had vaginal and/or anal penetration and/or oral sex
and/or genital to genital contact.
9. Participant or participant’s legally acceptable representative can read, understand, and
complete the eVRC.
criteria:
Type of Participant and Disease Characteristics
1. Is in good health based on medical history and physical examination according to the
clinical judgment of the investigator.
Demographics
2. Is assigned female sex at birth, from 16 years to 26 years of age inclusive, at the time of
providing the informed consent or assent, as applicable.
Follow local regulatory requirements if the legal age of consent for participation is >18
years of age.
Assigned Female Sex at Birth
3. A participant assigned female sex at birth is eligible to participate if not breastfeeding
during the study intervention period and for at least 30 days after the last dose of study
intervention.
4. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive
pregnancy test (urine or serum), as required by local regulations, has been obtained
within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of
study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous
result), a serum pregnancy test is required. Additional requirements for pregnancy testing
during and after study intervention are in Section 8.3.3.
5. A POCBP is eligible to participate if they use a contraceptive method that is highly
effective (with a failure rate of <1% per year), or if they adhere to penile-vaginal
intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and
persistent basis), as described in Appendix 5, during the intervention period and for at
least the time needed to eliminate each study intervention after the last dose of study
intervention. The length of time required to continue contraception for the study
intervention is: 7 months
Informed Consent
6. The participant (or legally acceptable representative) has provided documented informed
consent and the participant has provided documented assent, when applicable, for the
study.
Additional Categories
7. Agrees to provide study personnel with a primary telephone number as well as an
alternate form of contact, if available, for follow-up purposes.
8. Has a lifetime history of 0 to 4 sexual partners of any sex/gender at the time of
enrollment. Sexual partner is defined as an individual with whom the participant has had
penile penetrative sexual intercourse or has contacted the participant’s genitalia during
sexual activity, defined as having had vaginal and/or anal penetration and/or oral sex
and/or genital to genital contact.
9. Participant or participant’s legally acceptable representative can read, understand, and
complete the eVRC.
Exclusion Criteria
An individual must be excluded from the study if the individual meets any of the following
criteria:
For items denoted with an asterisk (*), if the exclusion criterion is met, then the Day 1
(Visit 1) may be rescheduled for a time when the criterion is not met.
Medical Conditions
1. *Had a recent fever (defined as oral temperature ≥100.4°F or ≥38.0°C) within 24 hours of
the Day 1 Visit.
2. Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty
breathing, hypotension, or shock) that required medical intervention.
3. Is allergic to any component of V540A or V503 vaccine.
Note: An allergy to vaccine components is defined as an allergic reaction that meet the
criteria for severe AEs or SAEs (Appendix 3).
4. Has known or history of functional or anatomic asplenia.
5. Is currently immunocompromised or has been diagnosed as having congenital or acquired
immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus,
rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other
autoimmune condition.
6. Has thrombocytopenia or other coagulation disorder contraindicating IM vaccination or
repeated venipuncture.
7. In the opinion of the investigator, has a history of clinically relevant drug or alcohol use
that would interfere with participation in protocol-specified activities.
8. Has a history or current evidence of any condition, therapy, laboratory abnormality or
other circumstance that might confound the results of the study, or interfere with the
participant’s participation for the full duration of the study, such that it is not in the best
interest of the participant to participate by judgment of investigator.
Note: The history of medical conditions will be based on the self-report or medical chart
provided by participant.
9. Has had a positive test for HPV.
10. Has a history of RRP or HPV-related head and neck cancer, or HPV-related anal lesions
(eg, condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
11. Has a history of an abnormal cervical biopsy result (showing CIN or worse).
12. Is expecting to donate eggs during the intervention period of the study.
13. Has a history of HPV-related external genital lesions (eg, condyloma acuminata or vulvar
intraepithelial neoplasia) or external genital cancer, HPV-related vaginal legions (eg,
condyloma acuminata, or vaginal intraepithelial neoplasia) or vaginal cancer.
criteria:
For items denoted with an asterisk (*), if the exclusion criterion is met, then the Day 1
(Visit 1) may be rescheduled for a time when the criterion is not met.
Medical Conditions
1. *Had a recent fever (defined as oral temperature ≥100.4°F or ≥38.0°C) within 24 hours of
the Day 1 Visit.
2. Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty
breathing, hypotension, or shock) that required medical intervention.
3. Is allergic to any component of V540A or V503 vaccine.
Note: An allergy to vaccine components is defined as an allergic reaction that meet the
criteria for severe AEs or SAEs (Appendix 3).
4. Has known or history of functional or anatomic asplenia.
5. Is currently immunocompromised or has been diagnosed as having congenital or acquired
immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus,
rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other
autoimmune condition.
6. Has thrombocytopenia or other coagulation disorder contraindicating IM vaccination or
repeated venipuncture.
7. In the opinion of the investigator, has a history of clinically relevant drug or alcohol use
that would interfere with participation in protocol-specified activities.
8. Has a history or current evidence of any condition, therapy, laboratory abnormality or
other circumstance that might confound the results of the study, or interfere with the
participant’s participation for the full duration of the study, such that it is not in the best
interest of the participant to participate by judgment of investigator.
Note: The history of medical conditions will be based on the self-report or medical chart
provided by participant.
9. Has had a positive test for HPV.
10. Has a history of RRP or HPV-related head and neck cancer, or HPV-related anal lesions
(eg, condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
11. Has a history of an abnormal cervical biopsy result (showing CIN or worse).
12. Is expecting to donate eggs during the intervention period of the study.
13. Has a history of HPV-related external genital lesions (eg, condyloma acuminata or vulvar
intraepithelial neoplasia) or external genital cancer, HPV-related vaginal legions (eg,
condyloma acuminata, or vaginal intraepithelial neoplasia) or vaginal cancer.
The Estimated Number of Participants
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Taiwan
45 participants
-
Global
525 participants
