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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_084 |
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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 GARDASILâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| qHPV Vaccine in Base Study | Experimental | 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. |
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| Placebo in Base Study | Placebo Comparator | 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. |
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| qHPV Vaccine in Extension Study | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V501 | Biological | 0.5 mL intramuscular injection of V501 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | 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. | Up to Month 18 |
| Number of Participants Reporting SAEs From Month 18 Through Month 37 | Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37 | Month 18 to Month 37 |
| Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18 | Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | 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. | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) |
| Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | 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. | Month 7 (1 Month Postdose 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17484215 | Background | Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. doi: 10.1097/01.inf.0000253970.29190.5a. | |
| 18000825 |
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1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | qHPV Vaccine in Base Study | 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. |
| FG001 | Placebo in Base Study | 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. |
| FG002 | qHPV Vaccine in Extension Study | Represent 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Vaccine Phase (Day 1 to Month 7) |
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| Base Follow-up Phase (Month 7 to 18) |
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| Base Follow-up Phase (Month 18 to 30) |
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| Extension Vaccine Phase (Month 30 to 37) |
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| Long-term Follow-up (Month 42 Visit) |
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| Long-term Follow-up (Month 72 Visit) |
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| Long-term Follow-up (Month 96 Visit) |
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| Long-term Follow-up (Month 126 Visit) |
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| ID | Title | Description |
|---|---|---|
| BG000 | qHPV Vaccine in Base Study | 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 |
| BG001 | Placebo in Base Study |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | 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. | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | Posted | Number | participants | Up to Month 18 |
|
Day 1 to Month 30 and Month 30 to Month 126
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.
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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 | qHPV Vaccine in Base: Vaccine Phase and Follow-up | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 7.1 | Non-systematic Assessment |
The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Comparator: Placebo | Biological | 0.5 mL intramuscular injection of placebo |
|
| Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group) |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | 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. | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group) |
| Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | 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. | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) |
| Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | 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. | Month 37 to Month 126 |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (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. | Month 18 (12 Months Post-dose 3) |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | 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. | Month 24 (18 Months Post-dose 3) |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | 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. | Month 30 (24 Months Post-dose 3) |
| Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | 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. | Month 37 (31 Months Post-dose 3) |
| Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | 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. | Month 37 (1 Month Post-dose 3 of qHPV) |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Month 7 (1 Month Post-dose 3) |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Month 18 (Month 12 Post-dose 3) |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Month 24 (18 Months Post-dose 3) |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Month 30 (24 Months Post-dose 3) |
| Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Month 37 (31 Months Post-dose 3) |
| Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Month 37 (1 Month Post-dose 3 of qHPV) |
| Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females | 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. | Up to Month 126 |
| Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males | 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. | Up to Month 126 |
| Background |
| Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260. |
| 25136050 | Result | Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, Mehlsen J, Chatterjee A, Iversen OE, Sings HL, Shou Q, Sausser TA, Saah A. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014 Sep;134(3):e657-65. doi: 10.1542/peds.2013-4144. Epub 2014 Aug 18. |
| 29167376 | Result | Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J, Chatterjee A, Iversen OE, Joshi A, Chu JL, Krick AL, Saah A, Das R. 4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years. Pediatrics. 2017 Dec;140(6):e20163947. doi: 10.1542/peds.2016-3947. |
| 19935017 | Derived | Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21. |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Moved |
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| per sponsor request: (noncompliant) |
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| Did not meet local regulations |
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| Refused Vaccination |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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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
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| OG001 | Placebo in Base Study | 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 |
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| Primary | Number of Participants Reporting SAEs From Month 18 Through Month 37 | Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37 | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | Posted | Number | participants | Month 18 to Month 37 |
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| Primary | Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18 | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | Posted | Number | participants | Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination |
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| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | 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. | Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) |
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| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) |
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| Primary | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group) |
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| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group) |
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| Primary | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) |
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| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) |
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| Primary | Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | 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 analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up. | Posted | Number | Participants | Month 37 to Month 126 |
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| Secondary | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7) | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 7 (1 Month Postdose 3) |
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| Secondary | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 18 (12 Months Post-dose 3) |
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| Secondary | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24) | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 24 (18 Months Post-dose 3) |
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| Secondary | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30) | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 30 (24 Months Post-dose 3) |
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| Secondary | Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37). | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 37 (31 Months Post-dose 3) |
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| Secondary | Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37) | 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. | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 37 (1 Month Post-dose 3 of qHPV) |
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| Secondary | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 7 (1 Month Post-dose 3) |
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|
|
| Secondary | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 18 (Month 12 Post-dose 3) |
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| Secondary | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 24 (18 Months Post-dose 3) |
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|
|
| Secondary | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 30 (24 Months Post-dose 3) |
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|
| Secondary | Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 37 (31 Months Post-dose 3) |
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| Secondary | Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units/mL | Month 37 (1 Month Post-dose 3 of qHPV) |
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| Secondary | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females | 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. | Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit. | Posted | Number | 95% Confidence Interval | Cases per 100 person-years at risk | Up to Month 126 |
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| Secondary | Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males | 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. | Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit. | Posted | Number | 95% Confidence Interval | Cases per 100 person-years at risk | Up to Month 126 |
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|
|
| 6 |
| 1,165 |
| 918 |
| 1,165 |
| EG001 | Placebo 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. | 0 | 584 | 344 | 584 |
| EG002 | qHPV Vaccine in Base: Extension and Long-term 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. | 2 | 932 | 0 | 932 |
| EG003 | qHPV Vaccine in Extension: Extension and Long-term Follow-up | Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited. | 3 | 481 | 3 | 481 |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| VIIth nerve paralysis | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Tonic clonic movements | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| Type 16: n=473, 154 |
|
| Type 18: n=477, 160 |
|
| Type 16: n=473, 154 |
|
| Type 18: n=477, 160 |
|
| Type 16: n=447, 143 |
|
| Type 18: n=452, 152 |
|
| Type 16: n=447, 143 |
|
| Type 18: n=452, 152 |
|
| Type 16: n=403, 115 |
|
| Type 18: n=408, 120 |
|
| Type 16: n=403, 115 |
|
| Type 18: n=408, 120 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=956 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=940 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=447 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=803 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=660 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=255 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=956 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=940 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=447 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=803 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=660 |
|
| Title | Measurements |
|---|---|
|
| Type 18: n=255 |
|