Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Phase 3

Completed

Conditions: Anogenital Human Papilloma Virus Infection
Condyloma Acuminata

Interventions: Biological: V501

Registration Number: NCT02576054

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: This is a study of V501 \[quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine\] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be \>90% at 4 weeks postdose 3.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 101

Inclusion Criteria

Healthy Japanese male
Have a legal representative who provides written informed consent for the trial on the participant's behalf
Have a legal representative who is able to read, understand, and complete the vaccine report card
Has not yet had coitarche and does not plan on becoming sexually active from Day 1 through Month 7 of the study
Other inclusion criteria will be discussed with the investigator during screening

Exclusion Criteria

Currently enrolled in clinical studies of investigational agents
History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
History of severe allergic reaction that required medical intervention
Allergic to any vaccine component, including aluminum, yeast, or BENZONASE™
Received immune globulin or blood-derived products in the past 6 months or plans to receive any before Month 7 of the study
History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids
Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
Ongoing alcohol or drug abuse within the past 12 months
History of genital warts or a positive test for HPV

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
V501	V501	0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Elevated Oral Temperature (>=37.5° C)	Up to Day 5 after any vaccination	The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized.
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18	Four weeks postdose 3 (Month 7)	Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL.
Percentage of Participants With a Systemic Adverse Event	Up to Day 15 after any vaccination	An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With an Injection-site Adverse Event	Up to Day 5 after any vaccination	An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Percentage of Participants With a Serious Adverse Event	Up to Day 15 after any vaccination	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.
Percentage of Participants With a Vaccine-related Serious Adverse Event	Up to 30 months	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years	Four weeks postdose 3 (Month 7)	Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed mMU/mL. GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority.
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months	24 months postdose 3 (30 months)	Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24.
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months	12 months postdose 3 (18 months)	Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months	24 months postdose 3 (30 months)	Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months	12 months postdose 3 (18 months)	Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24