Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Uterine Cervical Neoplasms

Adenocarcinoma

Communicable Diseases

Papillomavirus Infections

Vaginal Neoplasms

Vulvar Neoplasms

Condylomata Acuminata

Adenocarcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Diseases

Carcinoma in Situ

Vaginal Diseases

Vaginal Cancer

Vulvar Cancer

All Drugs and Chemicals

Vaccines

Participants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection

9vHPV vaccine

Medical Director

This study will evaluate the safety and immunogenicity of V503 (GARDASIL™9, 9vHPV vaccine) administered to 9- to 26-year-old females and males in Vietnam. The study hypothesis states that V503 induces acceptable anti-human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion at 4 weeks postdose 3.

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)

A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26-Year-Old Females and Males in Vietnam

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.

An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were 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.

An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The only solicited systemic AE was in response to results of daily oral temperature assessments. The participant or the parent/guardian of the participant will be asked to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature \[(≥ 37.8 °C (100.0 °F)\] was summarized.

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.

Merck Sharp & Dohme LLC

Population for All-cause mortality included all enrolled participants. Population for Non-serious adverse events and serious adverse events included all participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.

Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

9vHPV Vaccine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Clinical Trials Disclosure

Anti-HPV 6

Anti-HPV 11

Anti-HPV 16

Anti-HPV 18

Anti-HPV 31

Anti-HPV 33

Anti-HPV 45

Anti-HPV 52

Anti-HPV 58

All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.

Percentage of Participants With a Solicited Injection-site Adverse Event

Percentage of Participants With a Solicited Systemic Adverse Event

Percentage of Participants With a Vaccine-related Serious Adverse Event

Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1

Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Participants received a single 0.5-mL intramuscular injection of the 9-valent human papillomavirus (9vHPV) vaccine at Day 1, Month 2, and Month 6

Overall Study

Digestive System Diseases

Anus Neoplasms

Warts

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Anal Cancer

Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

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

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.

Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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

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.

Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study 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 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.

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 all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.

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

Heterosexual and MSM Males

Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6

Females

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

Heterosexual Males

Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6

Men Who Have Sex With Men (MSM)

Total

Senior Vice President, Global Clinical Development

Anti-HPV Type 6 (n=847, 708, 164)

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)

Men Who Have Sex With Men

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.

Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine

Overall injection-site AEs

Injection-site Erythema

Injection-site Pain

Injection-site Swelling

Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card

Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)

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.

Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine

Percentage of Participants With an Adverse Event

Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event

Persistent Infection

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6

9-valent human papillomavirus vaccine (9vHPV) is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles (VLPs) of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.

0.9% sodium chloride given as a 0.5-mL intramuscular injection

Placebo (Saline for Injection)

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

Healthy male participants between the ages of 20 and 45 years (inclusive)

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same human papillomavirus (HPV) type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.

Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.

Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV competitive Luminex immunoassay (cLIA) titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.

Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.

A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.

Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6

Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12

Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6

A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age

cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL.

cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.

cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized.

cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.

IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.

An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs.

A 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, or is another important medical event.

IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.

IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized

Pharmaceutical Solutions

Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.

Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.

9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection

Sterile saline solution administered as a 0.5 mL IM injection

Placebo

This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.

Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age

This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 3 or more consecutive visits over a period of at least 12 months.

This endpoint is defined as having occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of genital warts, PIN of any grade, or penile/perianal/perineal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.

This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 2 or more consecutive visits over a period of at least 6 months.

GMTs to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a Competitive Luminex Immunoassay (cLIA).

A participant who changes serostatus from seronegative at Day 1 to seropositive at one month post-Dose 3 for a given HPV type is considered to have achieved seroconversion for that type. A participant with a titer at or above the seropositivity cutoff for a given HPV type, as measured by cLIA, is considered seropositive for that type.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An 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, or is another important medical event.

This endpoint is defined to have occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of AIN of any grade or anal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)	NCT03546842	Papillomavirus ... Uterine Cervica... Vulvar Neoplasm... Vaginal Neoplas... Adenocarcinoma ... Condylomata Acu...	9vHPV vaccine	9 Years - 26 Years	Merck Sharp & Dohme LLC
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)	NCT01651949	Genital Warts Anal Cancer Anal Intraepith...	9vHPV Vaccine	16 Years - 26 Years	Merck Sharp & Dohme LLC
Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)	NCT04199689	Papillomavirus ...	9vHPV Vaccine Placebo (Saline...	20 Years - 45 Years	Merck Sharp & Dohme LLC
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)	NCT01651949	Genital Warts Anal Cancer Anal Intraepith...	9vHPV Vaccine	16 Years - 26 Years	Merck Sharp & Dohme LLC
Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)	NCT04199689	Papillomavirus ...	9vHPV Vaccine Placebo (Saline...	20 Years - 45 Years	Merck Sharp & Dohme LLC
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)	NCT05450705	Papillomavirus ...	9vHPV vaccine	9 Years - 26 Years	Merck Sharp & Dohme LLC
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)	NCT05285826	Papillomavirus ...	9vHPV Vaccine Placebo	20 Years - 45 Years	Merck Sharp & Dohme LLC
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)	NCT05285826	Papillomavirus ...	9vHPV Vaccine Placebo	20 Years - 45 Years	Merck Sharp & Dohme LLC
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)	NCT03546842	Papillomavirus ... Uterine Cervica... Vulvar Neoplasm... Vaginal Neoplas... Adenocarcinoma ... Condylomata Acu...	9vHPV vaccine	9 Years - 26 Years	Merck Sharp & Dohme LLC
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)	NCT05450705	Papillomavirus ...	9vHPV vaccine	9 Years - 26 Years	Merck Sharp & Dohme LLC

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