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| ID | Type | Description | Link |
|---|---|---|---|
| V503-069 | Other Identifier | MSD | |
| 2022-500253-37 | Registry Identifier | EU CT | |
| U1111-1274-2496 | Registry Identifier | UTN | |
| 2020-003736-24 | EudraCT Number |
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This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients) | Experimental | 10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1. |
|
| Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart | Experimental | 9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12. |
|
| Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart | Experimental | 9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24. |
|
| Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart | Experimental | 9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36. |
|
| Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart | Experimental | 9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9vHPV vaccine | Biological | 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay | Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL). | 4 weeks post last vaccination (Up to ~Month 61) |
| Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed. | Up to 5 days post vaccination |
| Percentage of Participants With at Least 1 Systemic Adverse Event | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed. | Up to 15 days post vaccination |
| Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event | A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed. | 4 weeks post last vaccination |
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Inclusion Criteria:
Boys and Girls 9 to 15 Years:
- Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
Cohort 0 Participants:
- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Exclusion Criteria:
All Participants:
Healthy male and female participants between the ages of 9 to 15 years (inclusive) and female participants between the ages of 16 and 26 years (inclusive) will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Daly City ( Site 0044) | Daly City | California | 94015 | United States | ||
| Kaiser Permanente Oakland ( Site 0020) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33857679 | Result | Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12. | |
| 38978512 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period | Active Comparator | 16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6. |
|
| Entire study period (Up to ~Month 96) |
| Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL. | 12 months post last vaccination |
| Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed. | 12 months post last vaccination |
| Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL. | 24 months post last vaccination |
| Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed. | 24 months post last vaccination |
| Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL. | 36 months post last vaccination |
| Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed. | 36 months post last vaccination |
| Oakland |
| California |
| 94611 |
| United States |
| Kaiser Permanente Roseville ( Site 0047) | Roseville | California | 95661 | United States |
| Kaiser Permanente Sacramento ( Site 0043) | Sacramento | California | 95815 | United States |
| Kaiser Permanente South Sacramento ( Site 0045) | Sacramento | California | 95823 | United States |
| Kaiser Permanente San Jose ( Site 0046) | San Jose | California | 95119 | United States |
| Kaiser Permanente Santa Clara ( Site 0042) | Santa Clara | California | 95051 | United States |
| Encompass Clinical Research ( Site 0022) | Spring Valley | California | 91978 | United States |
| Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007) | Naples | Florida | 34102 | United States |
| Tribe Clinical Research, LLC ( Site 0010) | Greenville | South Carolina | 29607 | United States |
| Coastal Carolina Research Center ( Site 0032) | North Charleston | South Carolina | 29405 | United States |
| Coastal Bend Clinical Research ( Site 0025) | Corpus Christi | Texas | 78413 | United States |
| University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si | Galveston | Texas | 77555 | United States |
| MultiCare Rockwood Cheney Clinic ( Site 0038) | Cheney | Washington | 99004 | United States |
| Fundación Centro de Investigación Clínica CIC ( Site 0157) | Medellín | Antioquia | 050021 | Colombia |
| Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151) | Chía | Cundinamarca | 250001 | Colombia |
| CAIMED México ( Site 0207) | Mexico City | Mexico City | 06760 | Mexico |
| AINPAD ( Site 0204) | Morelia | Michoacán | 58350 | Mexico |
| Unidad biomedica avanzada monterrey ( Site 0203) | Monterrey | Nuevo León | 64460 | Mexico |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( | Mérida | Yucatán | 97130 | Mexico |
| ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557) | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556) | Wroclaw | Lower Silesian Voivodeship | 50-369 | Poland |
| Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553) | Dębica | Podkarpackie Voivodeship | 39-200 | Poland |
| Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555) | Lodz | Łódź Voivodeship | 91-347 | Poland |
| Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351) | Johannesburg | Gauteng | 1864 | South Africa |
| TREAD Research ( Site 0354) | Cape Town | Western Cape | 7500 | South Africa |
| Desmond Tutu HIV Foundation ( Site 0355) | Cape Town | Western Cape | 7795 | South Africa |
| Taichung Veterans General Hospital ( Site 0653) | Taichung | 407 | Taiwan |
| National Taiwan University Hospital ( Site 0651) | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation.Linkou Branch ( Site 0652) | Taoyuan | 333 | Taiwan |
| Klein NP, Wiesner A, Bautista O, Group T, Kanu K, Li ZL, McCauley J, Saxena K, Tota J, Luxembourg A, Bonawitz R. Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine. Pediatrics. 2024 Aug 1;154(2):e2023064693. doi: 10.1542/peds.2023-064693. |
| Plain Language Summary | View source |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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