Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
- Conditions
- Papillomavirus Infections
- Interventions
- Biological: 9vHPV vaccine
- Registration Number
- NCT04708041
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 700
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:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
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
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Has received more than 1 dose of an HPV vaccine (Cohort 0)
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart 9vHPV vaccine 9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24. Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart 9vHPV vaccine 9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12. Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart 9vHPV vaccine 9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36. Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period 9vHPV vaccine 16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6. Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients) 9vHPV vaccine 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 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart 9vHPV vaccine 9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
- Primary Outcome Measures
Name Time Method 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 4 weeks post last vaccination (Up to ~Month 61) 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).
Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event Entire study period (Up to ~Month 96) 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.
Percentage of Participants With at Least 1 Systemic Adverse Event Up to 15 days post vaccination 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.
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event Up to 5 days post vaccination 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.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58 36 months post last vaccination 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.
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 36 months post last vaccination 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.
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 24 months post last vaccination 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.
Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 12 months post last vaccination 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.
Trial Locations
- Locations (30)
CAIMED México ( Site 0207)
🇲🇽Mexico City, Distrito Federal, Mexico
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
🇵🇱Lodz, Lodzkie, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
🇵🇱Tarnow, Malopolskie, Poland
Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
🇵🇱Debica, Podkarpackie, Poland
Tribe Clinical Research, LLC ( Site 0010)
🇺🇸Greenville, South Carolina, United States
Unidad biomedica avanzada monterrey ( Site 0203)
🇲🇽Monterrey, Nuevo Leon, Mexico
AINPAD ( Site 0204)
🇲🇽Morelia, Michoacan, Mexico
Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
🇨🇳Taoyuan, Taiwan
Coastal Carolina Research Center ( Site 0032)
🇺🇸North Charleston, South Carolina, United States
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
🇲🇽Merida, Yucatan, Mexico
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Kaiser Permanente South Sacramento ( Site 0045)
🇺🇸Sacramento, California, United States
Kaiser Permanente Oakland ( Site 0020)
🇺🇸Oakland, California, United States
Kaiser Permanente Sacramento ( Site 0043)
🇺🇸Sacramento, California, United States
Encompass Clinical Research ( Site 0022)
🇺🇸Spring Valley, California, United States
MultiCare Rockwood Cheney Clinic ( Site 0038)
🇺🇸Cheney, Washington, United States
Kaiser Permanente Santa Clara ( Site 0042)
🇺🇸Santa Clara, California, United States
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
🇨🇴Chia, Cundinamarca, Colombia
Fundación Centro de Investigación Clínica CIC ( Site 0157)
🇨🇴Medellín, Antioquia, Colombia
Taichung Veterans General Hospital ( Site 0653)
🇨🇳Taichung, Taiwan
Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
🇿🇦Johannesburg, Gauteng, South Africa
National Taiwan University Hospital ( Site 0651)
🇨🇳Taipei, Taiwan
Kaiser Permanente San Jose ( Site 0046)
🇺🇸San Jose, California, United States
Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
🇺🇸Naples, Florida, United States
Coastal Bend Clinical Research ( Site 0025)
🇺🇸Corpus Christi, Texas, United States
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
🇺🇸Galveston, Texas, United States
Kaiser Permanente Daly City ( Site 0044)
🇺🇸Daly City, California, United States
Kaiser Permanente Roseville ( Site 0047)
🇺🇸Roseville, California, United States
TREAD Research ( Site 0354)
🇿🇦Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation ( Site 0355)
🇿🇦Cape Town, Western Cape, South Africa