Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study.

Study Overview

• Status: Completed
• Conditions: Papillomavirus Infections
• Intervention / Treatment: Biological: 9vHPV vaccine

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukui, Japan, 910-8561
    • Fukui General Hospital ( Site 6614)
  • Osaka, Japan, 542-0076
    • Nomura Clinic Namba ( Site 6608)
  • Osaka, Japan, 554-0014
    • Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)
  • Tokyo, Japan, 101-0041
    • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)
  • Tokyo, Japan, 146-0095
    • Okawa Children & Family Clinic ( Site 6610)
  • Tokyo, Japan, 160-0022
    • Shinjuku Higashiguchi Clinic ( Site 6602)
  • Tokyo, Japan, 167-0051
    • Hayashi Clinic ( Site 6615)
  • Tokyo, Japan, 167-0051
    • Ogikuboekimae Clinic ( Site 6601)
  • Chiba
    • Isumi-shi, Chiba, Japan, 299-4503
      • Sotobo Children's Clinic ( Site 6616)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 062-0907
      • Ohigesenseino Kodomo Clinic ( Site 6607)
    • Sapporo, Hokkaido, Japan, 065-0024
      • Motomachi Pediatric Clinic ( Site 6606)
  • Osaka
    • Sakai, Osaka, Japan, 593-8322
      • Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Is Japanese male or female.
• Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old.
• Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC).
• Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.

Exclusion Criteria:

• Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit.
• Has a history of severe allergic reaction that required medical intervention.
• Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™.
• Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other auto immune condition.
• Has a history of splenectomy.
• Has a history of genital warts or positive test for human papillomavirus (HPV).
• Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. .
• Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy .
• Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG).
• Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination.
• Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo).
• Is concurrently enrolled in other clinical studies of investigational agents.
• Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-dose in 9 to 15 year old boys; 9 to 15 year old boys will receive a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).	Biological: 9vHPV vaccine; 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection; Other Names: V503; SILGARD®9; GARDASIL™9
Experimental: 2-dose in 9 to 14 year old boys; 9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).	Biological: 9vHPV vaccine; 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection; Other Names: V503; SILGARD®9; GARDASIL™9
Experimental: 2-dose in 9 to 14 year old girls; 9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).	Biological: 9vHPV vaccine; 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection; Other Names: V503; SILGARD®9; GARDASIL™9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 1 Systemic Adverse Event	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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.	Up to 15 days post vaccination
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive Luminex Immunoassay (cLIA). Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.	4 weeks post last vaccination (Month 7)
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	An adverse event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with solicited injection-site AEs (erythema/redness, pain and swelling) will be assessed.	Up to 5 days post vaccination
Percentage of Participants With at Least 1 Serious Adverse Event	A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.	Up to ~Month 30
Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event	A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.	Up to ~Month 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Serum antibodies to HPV types 6, 11, 16, 18 31, 33, 45, 52, and 58 will be measured with a cLIA. Titers are reported in milli Merck Units/mL.	4 weeks post last vaccination (Month 7)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): April 6, 2024
• Study Completion (Actual): April 6, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: V503-066 (Other Identifier: Merck); jRCT2031210080 (Registry Identifier: jRCT); 2020-001170-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes