Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Adenocarcinoma

Uterine Cervical Neoplasms

Adenocarcinoma in Situ

Uterine Cervical Dysplasia

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Carcinoma in Situ

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Immunologic Factors

Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6

V501

Medical Director

This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus \[qHPV\] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged 20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month 7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be eligible to participate in the Extension Stage and will be followed up to Month 60. No study vaccine will be administered during the Extension Stage.

A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)

A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years

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

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a cLIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using a Competitive Luminex Immunoassay (cLIA). This Outcome Measure applies only to participants aged 9 to 19 years.

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using cLIA. This Outcome Measure applies only to participants aged 9 to 19 years.

Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using an Immunoglobulin G Luminex Immunoassay (IgG LIA). This Outcome Measure applies only to participants aged 9 to 19 years.

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using IgG LIA. This Outcome Measure applies only to participants aged 9 to 19 years.

The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using cLIA.

Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.

An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment

In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.

The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. This Outcome Measure applies only to participants aged 9 to 19 years.

Merck Sharp & Dohme LLC

All participants that received at least 1 vaccination

Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Chinese Girls Aged 9 to 19 Years

Chinese Young Women Aged 20 to 26 Years

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

Anti-HPV 6

Anti-HPV 11

Anti-HPV 16

Anti-HPV 18

All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage.

Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA): Base Stage

Antibody Titers as Measured by cLIA: Extension Stage

Seropositivity Rates as Measured by cLIA: Extension Stage:

Antibody Titers as Measured by Immunoglobulin G Luminex Immunoassay: Extension Stage:

Seropositivity Rates as Measured by IgG LIA: Extension Stage:

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA: Base Stage

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA: Base Stage

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA: Base Stage

All participants that received at least 1 vaccination.

Percentage of Participants With a Solicited Injection-site Adverse Event (AE): Base Stage

Percentage of Participants With a Solicited Systemic AE: Base Stage

Percentage of Participants Who Have a Serious Adverse Event (SAE): Base Stage

Percentage of Participants With Any AE: Base Stage

< 37.2 °C (99.0 °F)

≥37.2 °C (99.0 °F) and < 38.3 °C (100.9 °F)

≥ 38.3 °C (100.9 °F) and < 39.3 °C (102.7 °F)

≥ 39.3 °C (102.7 °F) and < 40.3 °C (104.5 °F)

≥ 40.3 °C (104.5 °F)

Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria: Base Stage

Serious Adverse Events: Extension Stage:

Overall Study

Infections

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Communicable Diseases

Condylomata Acuminata

Virus Diseases

Papillomavirus Infections

Papilloma

Neoplasms, Squamous Cell

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

Placebo

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus \[HPV\] \[Type 6, 11, 16 and 18\] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.

Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.

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 percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.

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 percentage of participants with a systemic AE was summarized.

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. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.

Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.

The at-risk population was participants who received ≥1 study vaccination and had follow-up data available

If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.

Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection

Participants who received ≥1 study vaccination and had follow-up data available.

Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card

Injection-site erythema

Injection-site pain

Injection-site swelling

Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card

Percentage of Participants With a Systemic Adverse Event

Percentage of Participants With a Vaccine-related Systemic Adverse Event

If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease

0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

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.

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

A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys

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.

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.

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.

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.

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.

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.

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.

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.

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

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.

Population included all participants that received at least 1 vaccination

Anti HPV 6

Anti HPV 11

Anti HPV 16

Anti HPV 18

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18

≥ 37.5 °C (99.5 °F) and < 38.0 °C (100.4 °F)

≥ 38.0 °C (100.4 °F) and < 38.5 °C (101.3 °F)

≥ 38.5 °C (101.3 °F)

All participants who received at least 1 study vaccination and had follow-up safety data.

Percentage of Participants With Elevated Oral Temperature (>=37.5° C)

Percentage of Participants With an Injection-site Adverse Event

Percentage of Participants With a Serious Adverse Event

Percentage of Participants With a Vaccine-related Serious Adverse Event

Participants Aged 9 to 15 Years (PN200)

Participants Aged 16 to 26 Years (PN122)

Participants 9 to 15 years old (PN200) or 16 to 26 years old (PN122) that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.

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

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6

This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women

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

The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.

Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.

Asian

Race/Ethnicity, Customized

The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.

Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18

Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.

Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.

Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.

0.5 mL intramuscular injection of placebo

Comparator: Placebo

Medical Monitor

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.

The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.

The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.

Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.

Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.

qHPV Vaccine in Base: Vaccine Phase and Follow-up

Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.

Adverse events are reported for this group from Day 1 to Month 30.

Placebo in Base: Vaccine Phase and Follow-up

Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)	NCT03493542	Prevention of H...	V501	9 Years - 26 Years	Merck Sharp & Dohme LLC
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)	NCT01862874	Anogenital Huma... Condyloma Acumi...	V501 Placebo	16 Years - 26 Years	Merck Sharp & Dohme LLC
Safety and Tolerability Study of V501 in Japanese Boys (V501-200)	NCT02576054	Anogenital Huma... Condyloma Acumi...	V501	9 Years - 15 Years	Merck Sharp & Dohme LLC
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)	NCT01544478	Cervical Cancer Cervical Intrae... Adenocarcinoma ...	V501	16 Years - 26 Years	Merck Sharp & Dohme LLC
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)	NCT03493542	Prevention of H...	V501	9 Years - 26 Years	Merck Sharp & Dohme LLC
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)	NCT00092547	Human Papillomavirus ...	V501 Comparator: Pla...	9 Years - 15 Years	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for v501

Every month we try and update this database with for v501 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for v501

Every month we try and update this database with for v501 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for v501 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.