Papillomavirus Infections
Conditions
Brief summary
The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.
Interventions
BIOLOGICAL9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Is Japanese male or female. * Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old. * Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC). * Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.
Exclusion criteria
* Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit. * Has a history of severe allergic reaction that required medical intervention. * Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™. * Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. * Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other auto immune condition. * Has a history of splenectomy. * Has a history of genital warts or positive test for human papillomavirus (HPV). * Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. . * Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy . * Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG). * Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination. * Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo). * Is concurrently enrolled in other clinical studies of investigational agents. * Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled. * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | 1 month after final dose (Month 7) | The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination. |
| Number of Participants With at Least 1 Injection-site Adverse Event (AE) | Up to 5 days after each vaccination (up to ~6 months) | The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE 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. |
| Number of Participants With at Least 1 Systemic Adverse Event | Up to 15 days after each vaccination (up to ~6.5 months) | The number of participants with a systemic AE is reported. 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. |
| Number of Participants With at Least 1 Serious Adverse Event (SAE) | Up to ~Month 30 | The number of participants with an SAE is reported. An 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | 1 month after final dose (Month 7) | The GMT for each HPV serotype is presented. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). |
Countries
Japan
Participant flow
Pre-assignment details
This study was conducted at 12 centers in Japan.
Participants by arm
| Arm | Count |
|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys 9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6). | 105 |
| 2-dose Regimen: 9 to 14 Year Old Boys 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). | 104 |
| 2-dose Regimen: 9 to 14 Year Old Girls 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). | 105 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | 3-Dose Regimen: 9 to 15 Year Old Boys | 2-dose Regimen: 9 to 14 Year Old Boys | 2-dose Regimen: 9 to 14 Year Old Girls |
|---|---|---|---|---|
| Age, Continuous | 11.6 Years STANDARD_DEVIATION 1.8 | 11.8 Years STANDARD_DEVIATION 2 | 11.5 Years STANDARD_DEVIATION 1.7 | 11.4 Years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 314 Participants | 105 Participants | 104 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 314 Participants | 105 Participants | 104 Participants | 105 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 105 Participants | 0 Participants | 0 Participants | 105 Participants |
| Sex: Female, Male Male | 209 Participants | 105 Participants | 104 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 104 | 0 / 104 |
| other Total, other adverse events | 18 / 103 | 12 / 104 | 8 / 104 |
| serious Total, serious adverse events | 0 / 103 | 2 / 104 | 3 / 104 |
Outcome results
Primary
Number of Participants With at Least 1 Injection-site Adverse Event (AE)
The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE 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.
Time frame: Up to 5 days after each vaccination (up to ~6 months)
Population: All treated participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys | Number of Participants With at Least 1 Injection-site Adverse Event (AE) | 87 Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Number of Participants With at Least 1 Injection-site Adverse Event (AE) | 85 Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Number of Participants With at Least 1 Injection-site Adverse Event (AE) | 92 Participants |
Primary
Number of Participants With at Least 1 Serious Adverse Event (SAE)
The number of participants with an SAE is reported. An 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.
Time frame: Up to ~Month 30
Population: All treated participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys | Number of Participants With at Least 1 Serious Adverse Event (SAE) | 0 Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Number of Participants With at Least 1 Serious Adverse Event (SAE) | 2 Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Number of Participants With at Least 1 Serious Adverse Event (SAE) | 3 Participants |
Primary
Number of Participants With at Least 1 Systemic Adverse Event
The number of participants with a systemic AE is reported. 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.
Time frame: Up to 15 days after each vaccination (up to ~6.5 months)
Population: All treated participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys | Number of Participants With at Least 1 Systemic Adverse Event | 55 Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Number of Participants With at Least 1 Systemic Adverse Event | 41 Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Number of Participants With at Least 1 Systemic Adverse Event | 33 Participants |
Primary
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
Time frame: 1 month after final dose (Month 7)
Population: All participants who received all 9vHPV vaccinations at the correct dose and day range, have provided blood samples for serology within 21 to 49 days of the last dose, are seronegative to the appropriate HPV type(s) at Day 1, and had no protocol violations that could interfere with immune response, are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 100.0 Percentage of Participants |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Boys | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 100.0 Percentage of Participants |
| 2-dose Regimen: 9 to 14 Year Old Girls | Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 100.0 Percentage of Participants |
Secondary
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
The GMT for each HPV serotype is presented. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA).
Time frame: 1 month after final dose (Month 7)
Population: All participants who received all 9vHPV vaccinations at the correct dose and day range, have provided blood samples for serology within 21 to 49 days of the last dose, are seronegative to the appropriate HPV type(s) at Day 1, and had no protocol violations that could interfere with immune response, are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 2629.6 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 1401.7 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 894.9 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 2095.0 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 1759.8 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 925.3 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 7020.8 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 1341.8 GMT (mMU/mL) |
| 3-Dose Regimen: 9 to 15 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 848.9 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 1908.5 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 2417.0 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 1510.1 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 9808.5 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 2464.6 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 1272.1 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 508.4 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 587.4 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Boys | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 1350.6 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 16 | 9800.0 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 6 | 2343.2 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 45 | 599.6 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 11 | 1508.5 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 58 | 1379.8 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 31 | 1838.7 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 18 | 2999.8 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 52 | 582.7 GMT (mMU/mL) |
| 2-dose Regimen: 9 to 14 Year Old Girls | Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Anti-HPV 33 | 1283.1 GMT (mMU/mL) |