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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002758-22 | EudraCT Number |
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This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.
Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Females | Active Comparator | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Heterosexual Males | Experimental | Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Men who have Sex with Men | Experimental | Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9vHPV Vaccine | Biological | 9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL | Four weeks post vaccination 3 (Month 7) |
| Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | An adverse experience (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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination. | Up to 5 days after any vaccination |
| Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination | Up to 5 days after any vaccination |
| Percentage of Participants With an Adverse Event | 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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. | Up to Month 12 |
| Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8. | Four weeks post vaccination 3 (Month 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26144901 | Background | Castellsague X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2. | |
| 27422279 | Derived |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heterosexual Males | Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| FG001 | Females | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| FG002 | Men Who Have Sex With Men (MSM) | Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heterosexual Males | Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| BG001 | Females | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL | The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck Units/mL | Four weeks post vaccination 3 (Month 7) |
|
Up to Month 12
The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heterosexual and MSM Males | Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. |
| Up to Month 12 |
| Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15. |
| Protocol Violation |
|
| Physician Decision |
|
| Adverse Event |
|
| Screen failure |
|
| Withdrawal by Subject |
|
| BG002 | Men Who Have Sex With Men (MSM) | Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Females | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
| OG002 | Men Who Have Sex With Men | Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 |
|
|
|
| Primary | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | An adverse experience (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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination. | The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Posted | Number | Percentage of Participants | Up to 5 days after any vaccination |
|
|
|
|
| Primary | Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination | The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Posted | Number | Percentage of Participants | Up to 5 days after any vaccination |
|
|
|
|
| Secondary | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8. | The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Four weeks post vaccination 3 (Month 7) |
|
|
|
|
| Primary | Percentage of Participants With an Adverse Event | 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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. | The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Posted | Number | Percentage of Participants | Up to Month 12 |
|
|
|
| Primary | Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | 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 study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. | The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Posted | Number | Percentage of Participants | Up to Month 12 |
|
|
|
| 23 |
| 1,394 |
| 976 |
| 1,394 |
| EG001 | Females | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 | 26 | 1,075 | 924 | 1,075 |
| Familial periodic paralysis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cyst rupture | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Dengue fever | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| External ear cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Schizophreniform disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| Injection-site Pain |
|
| Injection-site Swelling |
|
Injection-site Pain |
| Miettinen & Nurminen |
| <0.001 |
| Risk Difference (RD) |
| -19.1 |
| 2-Sided |
| 95 |
| -22.5 |
| -15.7 |
The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants |
| Superiority or Other |
| Injection-site Swelling | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | -17.3 | 2-Sided | 95 | -20.8 | -13.7 | The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants | Superiority or Other |
| Anti-HPV Type 11 (n=851, 712, 165) |
|
| Anti-HPV Type 16 (n=899, 781, 212) |
|
| Anti-HPV Type 18 (n=906, 831, 220) |
|
| Anti-HPV Type 31 (n=908, 826, 227) |
|
| Anti-HPV Type 33 (n=901, 853, 230) |
|
| Anti-HPV Type 45 (n=909, 871, 232) |
|
| Anti-HPV Type 52 (n=907, 849, 232) |
|
| Anti-HPV Type 58 (n=897, 839, 223) |
|
Anti-HPV Type 11 |
| Miettinen & Nurminen |
| <0.001 |
| Risk Difference (RD) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.8 |
| Non-Inferiority or Equivalence |
Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 16 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.1 | 2-Sided | 95 | -0.3 | 0.7 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 18 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.1 | 2-Sided | 95 | -0.4 | 0.8 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 31 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.0 | 2-Sided | 95 | -0.4 | 0.5 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 33 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.1 | 2-Sided | 95 | -0.3 | 0.7 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 45 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.2 | 2-Sided | 95 | -0.4 | 1.0 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 52 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.2 | 2-Sided | 95 | -0.2 | 0.9 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |
| Anti-HPV Type 58 | Miettinen & Nurminen | <0.001 | Risk Difference (RD) | 0.2 | 2-Sided | 95 | -0.2 | 0.9 | Non-Inferiority or Equivalence | Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5 |