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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
700
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Kaiser Permanente Daly City ( Site 0044)
Daly City, California, United States
Kaiser Permanente Oakland ( Site 0020)
Oakland, California, United States
Kaiser Permanente Roseville ( Site 0047)
Roseville, California, United States
Kaiser Permanente Sacramento ( Site 0043)
Sacramento, California, United States
Kaiser Permanente South Sacramento ( Site 0045)
Sacramento, California, United States
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Entire study period (Up to ~Month 96)
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kaiser Permanente San Jose ( Site 0046)
San Jose, California, United States
Kaiser Permanente Santa Clara ( Site 0042)
Santa Clara, California, United States
Encompass Clinical Research ( Site 0022)
Spring Valley, California, United States
Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
Naples, Florida, United States
Tribe Clinical Research, LLC ( Site 0010)
Greenville, South Carolina, United States
...and 20 more locations
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.
Time frame: 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.
Time frame: 36 months post last vaccination