Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Papillomavirus Infections
About this trial
This is an interventional prevention trial for Papillomavirus Infections
Eligibility Criteria
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:
- 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
Exclusion Criteria:
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)
Sites / Locations
- Kaiser Permanente Daly City ( Site 0044)
- Kaiser Permanente Oakland ( Site 0020)
- Kaiser Permanente Roseville ( Site 0047)
- Kaiser Permanente Sacramento ( Site 0043)
- Kaiser Permanente South Sacramento ( Site 0045)
- Kaiser Permanente San Jose ( Site 0046)
- Kaiser Permanente Santa Clara ( Site 0042)
- Encompass Clinical Research ( Site 0022)
- Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
- Tribe Clinical Research, LLC ( Site 0010)
- Coastal Carolina Research Center ( Site 0032)
- Coastal Bend Clinical Research ( Site 0025)
- University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
- MultiCare Rockwood Cheney Clinic ( Site 0038)
- Fundación Centro de Investigación Clínica CIC ( Site 0157)
- Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
- CAIMED México ( Site 0207)
- AINPAD ( Site 0204)
- Unidad biomedica avanzada monterrey ( Site 0203)
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
- Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
- Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
- ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
- Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
- Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
- TREAD Research ( Site 0354)
- Desmond Tutu HIV Foundation ( Site 0355)
- Taichung Veterans General Hospital ( Site 0653)
- National Taiwan University Hospital ( Site 0651)
- Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart
Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart
Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart
Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
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.
9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.