Anal Cancer, Anal Intraepithelial Neoplasia, Genital Warts
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICAL9vHPV Vaccine
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
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Good physical health * Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results * Other inclusion criteria will be discussed with the investigator
Exclusion criteria
* History of severe allergic reaction that required medical intervention * Currently enrolled in a clinical trial * If participant is female, pregnant * Currently immunocompromised or having received immunosuppressive therapy in the last year * Positive test for HPV * History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer * If participant is female, history of abnormal cervical biopsy results * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Four weeks post vaccination 3 (Month 7) | 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 |
| Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Up to 5 days after any vaccination | 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. |
| Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | Up to 5 days after any vaccination | Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination |
| Percentage of Participants With an Adverse Event | Up to Month 12 | 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. |
| Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | Up to Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Four weeks post vaccination 3 (Month 7) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,106 |
| 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 | 1,101 |
| 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 | 313 |
| Total | 2,520 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 30 | 56 | 20 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 1 |
| Overall Study | Screen failure | 2 | 2 | 0 |
| Overall Study | Unknown status | 4 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 18 | 9 |
Baseline characteristics
| Characteristic | Heterosexual Males | Females | Men Who Have Sex With Men (MSM) | Total |
|---|---|---|---|---|
| Age, Continuous | 20.8 Years STANDARD_DEVIATION 3 | 21.3 Years STANDARD_DEVIATION 2.9 | 22.2 Years STANDARD_DEVIATION 2.4 | 21.2 Years STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 0 Participants | 1101 Participants | 0 Participants | 1101 Participants |
| Sex: Female, Male Male | 1106 Participants | 0 Participants | 313 Participants | 1419 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 976 / 1,394 | 924 / 1,075 |
| serious Total, serious adverse events | 23 / 1,394 | 26 / 1,075 |
Outcome results
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
Time frame: Four weeks post vaccination 3 (Month 7)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 235.6 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 808.2 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 616.7 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 384.8 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 708.5 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 782.0 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 386.8 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 3346.0 milli Merck Units/mL |
| Heterosexual Males | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 509.8 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 335.2 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 703.9 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 564.9 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 2788.3 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 679.8 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 570.1 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 322.0 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 185.7 milli Merck Units/mL |
| Females | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 409.3 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 252.3 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 2294.0 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 319.8 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 157.5 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 437.7 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 233.1 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 420.7 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 608.1 milli Merck Units/mL |
| Men Who Have Sex With Men | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 568.9 milli Merck Units/mL |
Comparison: Anti-HPV Type 6p-value: <0.00195% CI: [1.02, 1.21]ANOVA
Comparison: Anti-HPV Type 11p-value: <0.00195% CI: [1, 1.19]ANOVA
Comparison: Anti-HPV Type 16p-value: <0.00195% CI: [1.1, 1.3]ANOVA
Comparison: Anti-HPV Type 18p-value: <0.00195% CI: [1.08, 1.31]ANOVA
Comparison: Anti-HPV Type 31p-value: <0.00195% CI: [1.13, 1.37]ANOVA
Comparison: Anti-HPV Type 33p-value: <0.00195% CI: [1.1, 1.3]ANOVA
Comparison: Anti-HPV Type 45p-value: <0.00195% CI: [1.14, 1.41]ANOVA
Comparison: Anti-HPV Type 52p-value: <0.00195% CI: [1.05, 1.26]ANOVA
Comparison: Anti-HPV Type 58p-value: <0.00195% CI: [1.14, 1.36]ANOVA
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.
Time frame: Up to Month 12
Population: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heterosexual Males | Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | 0.1 Percentage of Participants |
| Females | Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | 0.3 Percentage of Participants |
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.
Time frame: Up to Month 12
Population: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heterosexual Males | Percentage of Participants With an Adverse Event | 76.2 Percentage of Participants |
| Females | Percentage of Participants With an Adverse Event | 89.4 Percentage of Participants |
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
Time frame: Up to 5 days after any vaccination
Population: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heterosexual Males | Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | 4.4 Percentage of Participants |
| Females | Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | 5.9 Percentage of Participants |
Comparison: Elevated Body Temperaturep-value: 0.09195% CI: [-3.4, 0.2]Miettinen & Nurminen
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.
Time frame: Up to 5 days after any vaccination
Population: The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Heterosexual Males | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Erythema | 20.7 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Swelling | 20.2 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Pain | 63.4 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Overall injection-site AEs | 66.7 Percentage of Participants |
| Females | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Pain | 82.5 Percentage of Participants |
| Females | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Erythema | 32.2 Percentage of Participants |
| Females | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Overall injection-site AEs | 84.0 Percentage of Participants |
| Females | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Injection-site Swelling | 37.5 Percentage of Participants |
Comparison: Injection-site Erythemap-value: <0.00195% CI: [-15, -8]Miettinen & Nurminen
Comparison: Injection-site Painp-value: <0.00195% CI: [-22.5, -15.7]Miettinen & Nurminen
Comparison: Injection-site Swellingp-value: <0.00195% CI: [-20.8, -13.7]Miettinen & Nurminen
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.
Time frame: Four weeks post vaccination 3 (Month 7)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 99.9 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 99.6 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 100 Percentage of Participants |
| Heterosexual Males | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 99.8 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 100 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 99.6 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 99.9 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 99.9 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 99.8 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 99.9 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 99.5 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 99.8 Percentage of Participants |
| Females | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 99.8 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 16 (n=899, 781, 212) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 6 (n=847, 708, 164) | 99.4 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 45 (n=909, 871, 232) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 11 (n=851, 712, 165) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 58 (n=897, 839, 223) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 31 (n=908, 826, 227) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 18 (n=906, 831, 220) | 99.5 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 52 (n=907, 849, 232) | 100 Percentage of Participants |
| Men Who Have Sex With Men | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Anti-HPV Type 33 (n=901, 853, 230) | 100 Percentage of Participants |
Comparison: Anti-HPV Type 6p-value: <0.00195% CI: [-0.7, 0.9]Miettinen & Nurminen
Comparison: Anti-HPV Type 11p-value: <0.00195% CI: [-0.3, 0.8]Miettinen & Nurminen
Comparison: Anti-HPV Type 16p-value: <0.00195% CI: [-0.3, 0.7]Miettinen & Nurminen
Comparison: Anti-HPV Type 18p-value: <0.00195% CI: [-0.4, 0.8]Miettinen & Nurminen
Comparison: Anti-HPV Type 31p-value: <0.00195% CI: [-0.4, 0.5]Miettinen & Nurminen
Comparison: Anti-HPV Type 33p-value: <0.00195% CI: [-0.3, 0.7]Miettinen & Nurminen
Comparison: Anti-HPV Type 45p-value: <0.00195% CI: [-0.4, 1]Miettinen & Nurminen
Comparison: Anti-HPV Type 52p-value: <0.00195% CI: [-0.2, 0.9]Miettinen & Nurminen
Comparison: Anti-HPV Type 58p-value: <0.00195% CI: [-0.2, 0.9]Miettinen & Nurminen