Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women
4 other identifiers
interventional
700
6 countries
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2021
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 23, 2029
April 20, 2025
April 1, 2025
8.6 years
January 12, 2021
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Entire study period (Up to ~Month 96)
Secondary Outcomes (7)
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
4 weeks post last vaccination
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
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
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
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
24 months post last vaccination
- +2 more secondary outcomes
Study Arms (6)
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
EXPERIMENTAL10 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
EXPERIMENTAL9 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
EXPERIMENTAL9 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
EXPERIMENTAL9 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
EXPERIMENTAL9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
ACTIVE COMPARATOR16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.
Interventions
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Kaiser Permanente Daly City ( Site 0044)
Daly City, California, 94015, United States
Kaiser Permanente Oakland ( Site 0020)
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 District, 333, Taiwan
Related Publications (2)
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.
PMID: 33857679RESULTKlein 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.
PMID: 38978512RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 13, 2021
Study Start
March 15, 2021
Primary Completion (Estimated)
October 23, 2029
Study Completion (Estimated)
October 23, 2029
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf