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

Papillomavirus Infections Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772534
• Other study ID #: V503-066
• Secondary ID: V503-066jRCT2031
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2021
• Est. completion date: April 6, 2024

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 6, 2024
• Est. primary completion date: April 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
Japan	Fukui General Hospital ( Site 6614)	Fukui
Japan	Sotobo Children's Clinic ( Site 6616)	Isumi-shi	Chiba
Japan	Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)	Osaka
Japan	Nomura Clinic Namba ( Site 6608)	Osaka
Japan	Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)	Sakai	Osaka
Japan	Motomachi Pediatric Clinic ( Site 6606)	Sapporo	Hokkaido
Japan	Ohigesenseino Kodomo Clinic ( Site 6607)	Sapporo	Hokkaido
Japan	Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)	Tokyo
Japan	Hayashi Clinic ( Site 6615)	Tokyo
Japan	Ogikuboekimae Clinic ( Site 6601)	Tokyo
Japan	Okawa Children & Family Clinic ( Site 6610)	Tokyo
Japan	Shinjuku Higashiguchi Clinic ( Site 6602)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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	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)

External Links

•   Merck Clinical Trials Information