Cervical Intraepithelial Neoplasia
Conditions
Keywords
Human papillomavirus, Infection, Vaccine, Women's health
Brief summary
The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.
Interventions
BIOLOGICALHPV9 High formulation
3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICALHPV9 Medium formulation
3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICALHPV9 Low formulation
3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICALGardasil 9
3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy participants as established by medical history and clinical examination before entering into the study. 2. For Step 1 only: Female between and including 18 and 26 years of age at the time of the first study intervention administration. 3. For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration. 4. Written informed consent obtained from the participant prior to performance of any study specific procedure (for participants below the legal age of consent as per local regulations, written informed consent must be obtained from the participant/participant's parent\[s\]/legally authorized representatives \[LAR{s}\] and, in addition, the participant should sign and personally date a written informed assent). 5. Participants and/or participants' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). 6. Female participant with no more than 4 lifetime sexual partners prior to enrollment. 7. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study if the participant: * has practiced adequate highly effective contraception for at least 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire intervention period and for 2 months after completion of the study intervention administration series.
Exclusion criteria
1. Pregnant or lactating female. 2. Female planning to become pregnant or planning to discontinue contraceptive precautions. 3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 4. History or current diagnosis of autoimmune disease. 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 6. Hypersensitivity to latex. 7. Major congenital defects, as assessed by the investigator. 8. History of abnormal Papanicolaou test or abnormal cervical biopsy result. 9. History of external genital/vaginal warts. 10. History of positive HPV test. 11. Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests 12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 13. Previous vaccination against HPV. 14. Previous exposure to monophosphoryl lipid A (MPL) or AS04 adjuvant. 15. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period. 16. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study interventions administration\* \*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is licensed and used according to its Product Information. 17. Administration of long-acting immune-modifying drugs at any time during the study period. 18. Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period. 19. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 milligram/kilogram/day (mg/kg/day) with maximum of 20 mg/day for participants under 18 years of age. Inhaled and topical steroids are allowed. 20. Administration of systemic immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period. 21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention. 22. History of /current chronic alcohol consumption and/or drug abuse. 23. Any study personnel or their immediate dependents, family, or household members. 24. Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | At Month 7 (one month after vaccine Dose 3 administration) | Anti-HPV IgG antibody concentrations were determined by electrochemiluminescence (ECL) assay and expressed as geometric mean concentrations (GMCs) in arbitrary units per milliliter (AU/mL). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. |
| Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Within 7 days after vaccine Dose 2 (administered at Month 2) | Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm. |
| Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Within 7 days after vaccine Dose 3 (administered at Month 6) | Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm. |
| Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Within 7 days after vaccine Dose 1 (administered at Day 1) | Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activities. |
| Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Within 7 days after vaccine Dose 2 (administered at Month 2) | Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity. |
| Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Within 7 days after vaccine Dose 3 (administered at Month 6) | Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity. |
| Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1 | Within 28 days after vaccine Dose 1 (administered at Day 1) | An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/legally acceptable representative(s) \[LAR(s)\] who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities. |
| Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2 | Within 28 days after vaccine Dose 2 (administered at Month 2) | An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities. |
| Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3 | Within 28 days after vaccine Dose 3 (administered at Month 6) | An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | From first vaccination (Day 1) to study end (Month 12) | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment. |
| Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | At Day 7 | As pre-specified in the protocol, the assessed biochemical parameters were blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Unknown = parameter value missing for the specified parameter. |
| Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | At Day 7 | As pre-specified in the protocol, the assessed hematological parameters were hemoglobin, white blood cells (WBC) increase, WBC decrease, lymphocyte decrease, neutrophils decrease, eosinophils, and platelets decrease. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. |
| Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | At Day 7 compared to baseline (Day 1) | The number of participants with clinically relevant abnormalities in hemoglobin change from baseline levels is reported. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. Change from baseline = the difference between a participant's baseline (pre-intervention) parameter values and their follow-up (post-intervention) parameter values. |
| Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Within 7 days after vaccine Dose 1 (administered at Day 1) | Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (\>) 50 millimeters (mm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Any Solicited Systemic Events | Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) | Assessed solicited systemic events included fever (defined as body temperature \>=37.5°C/99.5°F), headache, myalgia, arthralgia and fatigue. The preferred location for measuring temperature was the axilla. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination. |
| Number of Participants Reporting Any Unsolicited AEs | Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) | An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination. |
| Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | From first vaccination (Day 1) to study end (Month 12) | pIMDs are defined as a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Number of Participants Reporting Pregnancies | From Day 1 of pregnancy to study end (Month 12) | The number of participants who experienced pregnancy while participating in this study is reported. |
| Number of Participants With Outcomes of Reported Pregnancies | From Day 1 of pregnancy up to study end (Month 12) | The participants with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Pregnancy outcomes were live infant, no apparent congenital anomaly; elective termination, no apparent congenital anomaly, and ectopic pregnancy. |
| Anti-HPV IgG Antibody Concentrations | At Day 1, Month 2, Month 3, Month 6, Month 7 (Month 7 data was also reported in primary outcome measure 14, as pre-specified in protocol) and Month 12 | Anti-HPV IgG antibody concentrations were determined by ECL assay and expressed as GMCs in AU/mL. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. |
| Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | At Month 2, Month 3, Month 6, Month 7 and Month 12 | Seroconversion is defined as the appearance of antibodies \[i.e., concentration greater than or equal to (\>=) the lower limit of quantification (LLOQ) value\] in the serum of participants seronegative \[i.e, concentrations less than (\<) the LLOQ value\] before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 5100 AU/mL; HPV 11 type: LLOQ = 2480 AU/mL; HPV 16 type: LLOQ = 404 AU/mL; HPV 18 type: LLOQ = 1234 AU/mL; HPV 31 type: LLOQ = 3849 AU/mL; HPV 33 type: LLOQ = 617 AU/mL; HPV 45 type: LLOQ = 4079 AU/mL; HPV 52 type: LLOQ = 2352 AU/mL and HPV 58 type: LLOQ = 660 AU/mL. |
| Anti-HPV Neutralizing Titers | At Day 1, Month 3 and Month 7 | Anti-HPV neutralizing titers were determined by pseudovirion-based neutralization (PBNA) assay and expressed as geometric mean titers (GMTs). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. |
| Anti-HPV Neutralizing Titers in a Subset of Participants | At Month 2 | Anti-HPV neutralizing titers were determined by PBNA assay and expressed as GMTs. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. |
| Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | At Month 3 and Month 7 | Seroconversion is defined as the appearance of antibodies (i.e., titer \>=LLOQ value) in the serum of participants seronegative (i.e, titer \<LLOQ value) before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 269 titers; HPV 11 type: LLOQ = 279 titers; HPV 16 type: LLOQ = 339 titers; HPV 18 type: LLOQ = 84 titers; HPV 31 type: LLOQ = 96 titers; HPV 33 type: LLOQ = 323 titers; HPV 45 type: LLOQ = 76 titers; HPV 52 type: LLOQ = 104 titers and HPV 58 type: LLOQ = 95 titers. |
| Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | At Day 1, Month 2, Month 3 and Month 7 | The Pearson coefficient of correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers was calculated for each study group and for each antigen. The Pearson correlation was computed by the log10-transformation of specific antibody concentrations. |
| Number of Participants Reporting Any Solicited Administration Site Events | Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) | Assessed solicited administration site events included pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. |
Countries
Bulgaria, Czechia, Estonia, France, Germany, Lithuania, Poland, United States
Participant flow
Recruitment details
This study was organized into 2 steps. Step 1 sentinel participants received the initial assigned dose prior to participants in Step 2 of the study, and sentinel participants had an additional blood sampling visit at Day 7 to assess for biochemical and hematological parameters.
Pre-assignment details
A total of 1080 participants were enrolled into the study, of which 1079 participants received at least 1 dose of vaccine and were included in the Exposed Set.
Participants by arm
| Arm | Count |
|---|---|
| HPV9 High Group Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. | 270 |
| HPV9 Med Group Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. | 270 |
| HPV9 Low Group Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6. | 269 |
| Gar9 Group Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. | 270 |
| Total | 1,079 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 4 |
| Overall Study | Lost to Follow-up | 13 | 6 | 11 | 6 |
| Overall Study | Migrated/moved from the study area | 3 | 5 | 3 | 3 |
| Overall Study | Other | 9 | 7 | 7 | 8 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 4 | 11 |
Baseline characteristics
| Characteristic | HPV9 High Group | HPV9 Med Group | HPV9 Low Group | Gar9 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 22.0 Years STANDARD_DEVIATION 2.32 | 21.9 Years STANDARD_DEVIATION 2.56 | 22.1 Years STANDARD_DEVIATION 2.45 | 22.2 Years STANDARD_DEVIATION 2.25 | 22.1 Years STANDARD_DEVIATION 2.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 25 Participants | 27 Participants | 26 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 245 Participants | 245 Participants | 242 Participants | 244 Participants | 976 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 270 Participants | 270 Participants | 269 Participants | 270 Participants | 1079 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 270 | 0 / 270 | 0 / 269 | 0 / 270 |
| other Total, other adverse events | 260 / 270 | 265 / 270 | 262 / 269 | 254 / 270 |
| serious Total, serious adverse events | 1 / 270 | 4 / 270 | 2 / 269 | 7 / 270 |
Outcome results
Primary
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
Anti-HPV IgG antibody concentrations were determined by electrochemiluminescence (ECL) assay and expressed as geometric mean concentrations (GMCs) in arbitrary units per milliliter (AU/mL). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Time frame: At Month 7 (one month after vaccine Dose 3 administration)
Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time point. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 45 type antigen | 170959.55 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 33 type antigen | 154537.14 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 58 type antigen | 193735.34 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 18 type antigen | 181939.71 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 16 type antigen | 297480.37 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 11 type antigen | 276225.68 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 52 type antigen | 203994.24 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 31 type antigen | 241644.97 AU/mL |
| HPV9 High Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 6 type antigen | 124141.35 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 31 type antigen | 221590.60 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 45 type antigen | 174740.31 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 33 type antigen | 146931.12 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 11 type antigen | 250405.46 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 6 type antigen | 117881.81 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 16 type antigen | 272728.60 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 58 type antigen | 186513.90 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 52 type antigen | 196454.98 AU/mL |
| HPV9 Med Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 18 type antigen | 172862.73 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 31 type antigen | 230875.63 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 6 type antigen | 119724.25 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 11 type antigen | 260309.15 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 16 type antigen | 294326.70 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 18 type antigen | 183180.47 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 33 type antigen | 150919.88 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 45 type antigen | 174014.45 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 52 type antigen | 204005.75 AU/mL |
| HPV9 Low Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 58 type antigen | 190767.16 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 45 type antigen | 71768.92 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 18 type antigen | 86756.51 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 16 type antigen | 154844.90 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 58 type antigen | 93456.26 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 52 type antigen | 103497.80 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 11 type antigen | 187507.09 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 33 type antigen | 96875.65 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 31 type antigen | 104667.37 AU/mL |
| Gar9 Group | Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations | HPV 6 type antigen | 54710.66 AU/mL |
Primary
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
The number of participants with clinically relevant abnormalities in hemoglobin change from baseline levels is reported. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. Change from baseline = the difference between a participant's baseline (pre-intervention) parameter values and their follow-up (post-intervention) parameter values.
Time frame: At Day 7 compared to baseline (Day 1)
Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the hemoglobin change from baseline analysis at Day 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 0 | 5 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 1 | 5 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Unknown | 2 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 0 | 1 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 1 | 11 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 1 | 8 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 2 | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Unknown | 2 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 0 | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Unknown | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 1 | 6 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 0 | 5 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels | Hemoglobin change from baseline, Grade 2 | 0 Participants |
Primary
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
As pre-specified in the protocol, the assessed biochemical parameters were blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Unknown = parameter value missing for the specified parameter.
Time frame: At Day 7
Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the specified biochemical analyses at Day 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Unknown | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 0 | 12 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 0 | 11 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | BUN, Unknown | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | AST, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities | ALT, Grade 0 | 12 Participants |
Primary
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
As pre-specified in the protocol, the assessed hematological parameters were hemoglobin, white blood cells (WBC) increase, WBC decrease, lymphocyte decrease, neutrophils decrease, eosinophils, and platelets decrease. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter.
Time frame: At Day 7
Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the specified hematological analyses at Day 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 0 | 8 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 1 | 3 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 0 | 11 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 4 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 2 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 1 | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 0 | 10 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 1 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 3 | 0 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Unknown | 1 Participants |
| HPV9 High Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 1 | 1 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 0 | 10 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 3 | 1 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 0 | 11 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 1 | 1 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 0 | 11 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 2 | 1 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Unknown | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 0 | 12 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 1 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 2 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 3 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 4 | 0 Participants |
| HPV9 Med Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Unknown | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 0 | 10 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 1 | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 1 | 2 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 0 | 9 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 2 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 1 | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 0 | 10 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 3 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Unknown | 1 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 4 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 1 | 0 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 0 | 11 Participants |
| HPV9 Low Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 0 | 12 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 1 | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 1 | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 0 | 11 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 0 | 11 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 0 | 8 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 0 | 11 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 1 | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 0 | 12 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 1 | 1 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Grade 4 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Increase, Grade 3 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Neutrophils Decrease, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Grade 1 | 4 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Hemoglobin, Unknown | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | WBC Decrease, Grade 2 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Eosinophils, Grade 0 | 11 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Lymphocyte Decrease, Grade 1 | 0 Participants |
| Gar9 Group | Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities | Platelet Decrease, Unknown | 0 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (\>) 50 millimeters (mm).
Time frame: Within 7 days after vaccine Dose 1 (administered at Day 1)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the electronic diary (eDiary) for solicited events completed after the administration of vaccine Dose 1 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Pain | 11 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Swelling | 5 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Redness | 2 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Pain | 12 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Swelling | 3 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Redness | 4 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Redness | 2 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Pain | 6 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Swelling | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Pain | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Swelling | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1 | Grade 3 Redness | 0 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm.
Time frame: Within 7 days after vaccine Dose 2 (administered at Month 2)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 2 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Pain | 13 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Swelling | 5 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Redness | 4 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Pain | 6 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Swelling | 3 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Redness | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Redness | 2 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Pain | 11 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Swelling | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Pain | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Swelling | 3 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2 | Grade 3 Redness | 1 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm.
Time frame: Within 7 days after vaccine Dose 3 (administered at Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 3 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Pain | 9 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Swelling | 0 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Redness | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Pain | 3 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Swelling | 4 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Redness | 2 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Redness | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Pain | 6 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Swelling | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Pain | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Swelling | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3 | Grade 3 Redness | 1 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activities.
Time frame: Within 7 days after vaccine Dose 1 (administered at Day 1)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 1 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Arthralgia | 1 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Headache | 11 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fatigue | 12 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Myalgia | 5 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fever | 1 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Myalgia | 2 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Arthralgia | 1 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fatigue | 9 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Headache | 3 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fever | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Myalgia | 2 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fever | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Headache | 6 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Arthralgia | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fatigue | 7 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Arthralgia | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Headache | 3 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fever | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Myalgia | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1 | Grade 3 Fatigue | 5 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Time frame: Within 7 days after vaccine Dose 2 (administered at Month 2)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 2 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Arthralgia | 0 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Headache | 7 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fatigue | 12 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Myalgia | 4 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fever | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Myalgia | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Arthralgia | 2 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fatigue | 11 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Headache | 7 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fever | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Myalgia | 3 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fever | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Headache | 8 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Arthralgia | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fatigue | 12 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Arthralgia | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Headache | 5 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fever | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Myalgia | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 | Grade 3 Fatigue | 11 Participants |
Primary
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Time frame: Within 7 days after vaccine Dose 3 (administered at Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 3 and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Arthralgia | 2 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Headache | 10 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fatigue | 15 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Myalgia | 3 Participants |
| HPV9 High Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fever | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Myalgia | 3 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Arthralgia | 1 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fatigue | 8 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Headache | 4 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fever | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Myalgia | 2 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fever | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Headache | 9 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Arthralgia | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fatigue | 11 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Arthralgia | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Headache | 7 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fever | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Myalgia | 2 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3 | Grade 3 Fatigue | 6 Participants |
Primary
Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/legally acceptable representative(s) \[LAR(s)\] who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Time frame: Within 28 days after vaccine Dose 1 (administered at Day 1)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1 | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1 | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1 | 0 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1 | 1 Participants |
Primary
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Time frame: Within 28 days after vaccine Dose 2 (administered at Month 2)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2 | 4 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2 | 1 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2 | 3 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2 | 3 Participants |
Primary
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Time frame: Within 28 days after vaccine Dose 3 (administered at Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3 | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3 | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3 | 1 Participants |
| Gar9 Group | Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3 | 2 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Time frame: From first vaccination (Day 1) to study end (Month 12)
Population: Analysis was performed on the Exposed Set, which included participants who received a study vaccine and for whom data were available for the specified period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| HPV9 Med Group | Number of Participants Reporting Serious Adverse Events (SAEs) | 4 Participants |
| HPV9 Low Group | Number of Participants Reporting Serious Adverse Events (SAEs) | 2 Participants |
| Gar9 Group | Number of Participants Reporting Serious Adverse Events (SAEs) | 7 Participants |
Secondary
Anti-HPV IgG Antibody Concentrations
Anti-HPV IgG antibody concentrations were determined by ECL assay and expressed as GMCs in AU/mL. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Time frame: At Day 1, Month 2, Month 3, Month 6, Month 7 (Month 7 data was also reported in primary outcome measure 14, as pre-specified in protocol) and Month 12
Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 7 | 170959.55 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 6 | 68516.79 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 3 | 158592.29 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 7 | 241644.97 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 2 | 41618.25 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 6 | 45691.56 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 12 | 137744.87 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Day 1 | 624.29 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 12 | 114626.18 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 3 | 137598.43 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 2 | 18225.37 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 3 | 124361.59 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 3 | 231064.29 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 2 | 17122.75 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 6 | 43736.52 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 7 | 193735.34 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 7 | 154537.14 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Day 1 | 2431.92 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 12 | 79450.21 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 3 | 113669.75 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 2 | 35027.13 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 6 | 77600.50 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 7 | 276225.68 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Day 1 | 3621.58 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Day 1 | 692.12 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 12 | 129019.87 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Day 1 | 684.26 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 6 | 42722.37 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 12 | 123724.49 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 2 | 34918.40 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 3 | 252250.95 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 7 | 203994.24 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 6 | 101518.07 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 7 | 297480.37 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 7 | 124141.35 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 6 | 75353.61 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 12 | 166953.66 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Day 1 | 1246.54 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 2 | 29701.14 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 3 | 185490.54 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 2 | 21700.85 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 6 | 70466.12 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 3 | 137838.37 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 12 | 68118.04 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 2 | 75187.13 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 6 | 61676.34 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 7 | 181939.71 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Day 1 | 1641.65 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 12 | 84949.48 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Day 1 | 2748.41 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Day 1 | 2217.95 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 12 | 78692.83 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 2 | 32102.49 AU/mL |
| HPV9 High Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 3 | 161264.11 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 2 | 31250.65 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 6 | 38982.11 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 6 | 61717.39 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 7 | 196454.98 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 6 | 41003.12 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Day 1 | 2698.81 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 7 | 221590.60 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 3 | 217440.98 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 12 | 110249.43 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 7 | 174740.31 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 12 | 132414.54 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 2 | 37945.17 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 3 | 127933.76 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 6 | 51216.03 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Day 1 | 578.18 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 6 | 83015.52 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 6 | 66072.77 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 6 | 77979.01 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 2 | 16873.64 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 2 | 33438.25 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 2 | 17097.47 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 12 | 65112.37 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 3 | 113348.19 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 7 | 272728.60 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Day 1 | 1720.51 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Day 1 | 3377.84 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 6 | 41162.19 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 7 | 172862.73 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Day 1 | 2408.58 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 12 | 149269.66 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 7 | 146931.12 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 3 | 212805.15 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 7 | 117881.81 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 3 | 176024.77 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 12 | 75043.46 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 2 | 29699.92 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Day 1 | 1037.54 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 3 | 146413.17 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 6 | 67299.61 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 3 | 106471.07 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Day 1 | 615.45 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 2 | 31733.68 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 7 | 250405.46 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 12 | 77008.45 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 2 | 18029.88 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 3 | 144355.15 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 12 | 120984.83 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 7 | 186513.90 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 12 | 131043.47 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 2 | 83557.87 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Day 1 | 637.99 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 12 | 80653.92 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 3 | 127099.14 AU/mL |
| HPV9 Med Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Day 1 | 2105.07 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 6 | 35892.14 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Day 1 | 3124.40 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 2 | 23870.12 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 3 | 100258.49 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 6 | 32792.55 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 7 | 119724.25 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 12 | 59776.32 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Day 1 | 2013.18 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 2 | 29437.94 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 3 | 192296.18 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 6 | 57076.00 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 7 | 260309.15 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 12 | 117640.77 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Day 1 | 690.99 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 2 | 25605.94 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 3 | 201303.15 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 6 | 76558.80 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 7 | 294326.70 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 12 | 168097.78 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Day 1 | 1111.98 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 2 | 16571.70 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 3 | 123342.91 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 6 | 46904.59 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 7 | 183180.47 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 12 | 87334.91 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Day 1 | 2595.69 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 2 | 27652.57 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 3 | 133818.05 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 6 | 54672.61 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 7 | 230875.63 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 12 | 143396.41 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Day 1 | 566.26 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 2 | 14523.05 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 3 | 105284.68 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 7 | 150919.88 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 12 | 78826.94 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Day 1 | 2315.53 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 2 | 14345.03 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 3 | 113479.94 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 6 | 34796.86 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 7 | 174014.45 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 12 | 82021.92 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Day 1 | 1611.71 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 2 | 73047.67 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 3 | 164122.51 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 6 | 65136.98 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 7 | 204005.75 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 12 | 129678.87 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Day 1 | 643.72 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 2 | 30732.28 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 3 | 140028.57 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 6 | 57807.95 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 7 | 190767.16 AU/mL |
| HPV9 Low Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 12 | 115765.42 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 2 | 12606.73 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 12 | 26890.23 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 7 | 71768.92 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Day 1 | 2358.09 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 12 | 36658.81 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 2 | 10488.57 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 12 | 29716.61 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 7 | 86756.51 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 6 | 26774.11 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 3 | 79942.78 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Day 1 | 1549.58 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 3 | 79998.43 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Month 2 | 11081.57 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 7 | 54710.66 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 2 | 25513.64 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 18 type antigen, Day 1 | 952.51 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 12 | 85986.11 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 6 | 18744.02 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 3 | 95239.18 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 7 | 154844.90 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 6 | 56636.27 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Day 1 | 2970.65 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 6 | 32359.34 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 3 | 158136.76 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Month 2 | 17397.59 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 6 | 33188.99 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 7 | 103497.80 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 16 type antigen, Day 1 | 525.21 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 12 | 87423.54 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 6 type antigen, Month 3 | 63245.70 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 52 type antigen, Month 12 | 54071.66 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 7 | 187507.09 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 6 | 68934.35 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 12 | 51715.19 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Day 1 | 571.59 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 3 | 220402.45 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 12 | 46210.95 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 7 | 96875.65 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 6 | 30563.15 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Month 2 | 38760.82 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Day 1 | 2217.15 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 3 | 87895.71 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Month 2 | 12110.80 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 7 | 93456.26 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 2 | 6292.08 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 33 type antigen, Day 1 | 523.15 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 12 | 55178.34 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 58 type antigen, Month 2 | 13395.37 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 3 | 55337.26 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 7 | 104667.37 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 6 | 32131.34 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 11 type antigen, Day 1 | 1794.54 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 45 type antigen, Month 6 | 16153.45 AU/mL |
| Gar9 Group | Anti-HPV IgG Antibody Concentrations | HPV 31 type antigen, Month 3 | 89306.66 AU/mL |
Secondary
Anti-HPV Neutralizing Titers
Anti-HPV neutralizing titers were determined by pseudovirion-based neutralization (PBNA) assay and expressed as geometric mean titers (GMTs). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Time frame: At Day 1, Month 3 and Month 7
Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 3 | 31623.27 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 7 | 25204.55 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 7 | 69730.78 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Day 1 | 207.88 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 3 | 13822.73 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 3 | 17034.78 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Day 1 | 225.65 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 7 | 33246.87 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 3 | 13233.27 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Day 1 | 55.65 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 3 | 45690.44 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 7 | 17321.54 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Day 1 | 87.31 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Day 1 | 361.27 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 3 | 35416.74 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 7 | 51354.94 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 7 | 21604.03 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 7 | 83674.41 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 7 | 82061.27 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Day 1 | 73.24 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 3 | 18288.04 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 3 | 3994.46 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 7 | 9236.06 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Day 1 | 328.72 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Day 1 | 78.63 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Day 1 | 86.49 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 3 | 22472.04 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Day 1 | 280.37 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 7 | 20617.17 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 3 | 3610.97 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 7 | 64413.46 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Day 1 | 210.97 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 3 | 13197.57 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 3 | 31018.79 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Day 1 | 216.99 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 7 | 46896.70 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 7 | 75228.75 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Day 1 | 85.37 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 3 | 15199.08 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Day 1 | 85.98 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Day 1 | 61.43 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 7 | 75779.10 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 7 | 30752.43 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 7 | 9539.94 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 3 | 15548.20 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 3 | 12081.23 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 3 | 27936.10 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Day 1 | 87.15 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Day 1 | 63.14 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 7 | 16793.17 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 3 | 41126.63 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 7 | 24537.36 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 3 | 21241.61 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Day 1 | 325.48 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 7 | 20285.76 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Day 1 | 242.72 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 3 | 39346.74 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 7 | 71805.19 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Day 1 | 204.12 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 3 | 10838.85 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 7 | 16315.93 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Day 1 | 356.83 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 3 | 29774.15 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 7 | 81101.64 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 3 | 3528.45 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 7 | 9756.59 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Day 1 | 86.03 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 3 | 18317.84 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 7 | 59252.25 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Day 1 | 200.17 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 3 | 12923.25 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 7 | 27855.80 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Day 1 | 53.80 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 3 | 11113.74 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 7 | 22748.14 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Day 1 | 75.58 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 3 | 14606.62 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Day 1 | 64.18 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Day 1 | 82.06 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 3 | 27246.89 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 7 | 46983.15 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Day 1 | 76.01 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 7 | 33651.69 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 7 | 7853.20 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 7 | 3518.33 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Month 3 | 1705.98 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 7 | 22245.13 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Day 1 | 72.37 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 18 type antigen, Day 1 | 57.05 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 7 | 37820.19 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Month 3 | 11650.18 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 3 | 7903.98 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Month 3 | 21870.13 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 16 type antigen, Day 1 | 277.19 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Month 3 | 21637.85 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 52 type antigen, Month 7 | 10904.65 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 7 | 12607.96 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Month 3 | 11547.59 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 6 type antigen, Day 1 | 230.40 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 7 | 18696.71 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Month 3 | 9132.50 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 58 type antigen, Day 1 | 73.81 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Day 1 | 49.89 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 33 type antigen, Day 1 | 186.32 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 7 | 17581.92 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 11 type antigen, Day 1 | 189.59 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 45 type antigen, Month 3 | 3488.90 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers | HPV 31 type antigen, Month 3 | 9156.79 Titers |
Secondary
Anti-HPV Neutralizing Titers in a Subset of Participants
Anti-HPV neutralizing titers were determined by PBNA assay and expressed as GMTs. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Time frame: At Month 2
Population: Analysis was performed on a subset of participants from Per Protocol Set (PPS) for immunogenicity with post-vaccination immunogenicity results available for the specified analysis at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 16 type antigen | 5888.86 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 52 type antigen | 9664.68 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 31 type antigen | 4005.68 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 18 type antigen | 603.31 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 45 type antigen | 1382.24 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 11 type antigen | 2592.37 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 6 type antigen | 13438.35 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 33 type antigen | 1830.91 Titers |
| HPV9 High Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 58 type antigen | 5169.27 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 31 type antigen | 3612.79 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 6 type antigen | 11275.45 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 11 type antigen | 2441.65 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 16 type antigen | 4711.97 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 18 type antigen | 447.98 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 33 type antigen | 1782.19 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 45 type antigen | 1657.88 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 52 type antigen | 9081.81 Titers |
| HPV9 Med Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 58 type antigen | 5519.36 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 16 type antigen | 2947.73 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 31 type antigen | 2193.35 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 11 type antigen | 1531.82 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 33 type antigen | 1097.86 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 45 type antigen | 1119.04 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 6 type antigen | 6658.75 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 58 type antigen | 3848.83 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 52 type antigen | 8379.90 Titers |
| HPV9 Low Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 18 type antigen | 379.32 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 16 type antigen | 2987.06 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 45 type antigen | 369.17 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 31 type antigen | 1183.70 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 18 type antigen | 259.14 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 52 type antigen | 4052.45 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 11 type antigen | 2912.25 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 33 type antigen | 1182.00 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 6 type antigen | 3364.11 Titers |
| Gar9 Group | Anti-HPV Neutralizing Titers in a Subset of Participants | HPV 58 type antigen | 1569.91 Titers |
Secondary
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
The Pearson coefficient of correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers was calculated for each study group and for each antigen. The Pearson correlation was computed by the log10-transformation of specific antibody concentrations.
Time frame: At Day 1, Month 2, Month 3 and Month 7
Population: Analysis was performed on a subset of participants from Per Protocol Set for analysis of immunogenicity, which included participants with both concentration and titer values available for the specified analysis at the specified time points. Participants with values below the LLOQ or above ULOQ in either assay were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Day 1 | 0.664 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 2 | 0.965 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 7 | 0.814 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 2 | 0.840 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 7 | 0.777 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 3 | 0.871 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 7 | 0.649 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Day 1 | 0.850 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 2 | 0.824 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 7 | 0.866 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 2 | 0.666 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Day 1 | 0.721 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 3 | 0.797 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Day 1 | 0.903 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 3 | 0.806 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 7 | 0.820 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 2 | 0.794 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 2 | 0.885 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 3 | 0.800 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 3 | 0.846 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 2 | 0.748 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 3 | 0.881 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 7 | 0.659 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 2 | 0.834 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 7 | 0.851 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 7 | 0.899 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Day 1 | 0.632 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 3 | 0.831 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Day 1 | 0.809 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Day 1 | 0.751 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Day 1 | 0.934 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Day 1 | 0.907 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 3 | 0.811 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 2 | 0.768 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 3 | 0.813 Correlation coefficient |
| HPV9 High Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 7 | 0.869 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Day 1 | 0.921 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 3 | 0.800 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 3 | 0.863 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 7 | 0.824 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 2 | 0.733 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Day 1 | 0.843 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 2 | 0.859 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 2 | 0.790 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 2 | 0.831 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 3 | 0.767 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 2 | 0.851 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Day 1 | 0.885 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 7 | 0.807 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 3 | 0.808 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Day 1 | 0.818 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Day 1 | 0.816 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 7 | 0.839 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Day 1 | 0.927 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 7 | 0.834 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 2 | 0.951 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 3 | 0.790 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 3 | 0.862 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 3 | 0.821 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 7 | 0.893 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 3 | 0.721 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Day 1 | 0.863 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 2 | 0.832 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 2 | 0.885 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 7 | 0.810 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 3 | 0.880 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 7 | 0.860 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Day 1 | 0.790 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 7 | 0.871 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Day 1 | 0.811 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 7 | 0.870 Correlation coefficient |
| HPV9 Med Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 2 | 0.820 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 3 | 0.799 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Day 1 | 0.756 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 2 | 0.766 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 3 | 0.789 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 7 | 0.786 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Day 1 | 0.951 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 2 | 0.807 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 3 | 0.820 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 7 | 0.787 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Day 1 | 0.918 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 2 | 0.880 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 3 | 0.827 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 7 | 0.894 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Day 1 | 0.896 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 2 | 0.811 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 3 | 0.860 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 7 | 0.881 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Day 1 | 0.708 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 2 | 0.824 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 3 | 0.798 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 7 | 0.806 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Day 1 | 0.831 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 2 | 0.672 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 3 | 0.783 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 7 | 0.789 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Day 1 | 0.692 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 2 | 0.740 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 7 | 0.737 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Day 1 | 0.847 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 2 | 0.606 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 3 | 0.754 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 7 | 0.829 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Day 1 | 0.791 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 2 | 0.666 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 3 | 0.789 Correlation coefficient |
| HPV9 Low Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 7 | 0.825 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 3 | 0.882 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 2 | 0.745 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Day 1 | 0.344 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Day 1 | 0.830 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 7 | 0.882 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 7 | 0.905 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 3 | 0.884 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 7 | 0.892 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Day 1 | 0.804 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Month 2 | 0.866 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 18 type antigen, Day 1 | 0.920 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 3 | 0.867 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 2 | 0.767 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 7 | 0.894 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 3 | 0.904 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 7 | 0.851 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 3 | 0.861 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Month 2 | 0.958 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 16 type antigen, Day 1 | 0.951 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 3 | 0.852 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 52 type antigen, Month 7 | 0.831 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 7 | 0.820 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 3 | 0.856 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 6 type antigen, Month 2 | 0.786 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Day 1 | 0.831 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 7 | 0.768 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 3 | 0.859 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Month 2 | 0.820 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Day 1 | 0.557 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Month 2 | 0.711 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 33 type antigen, Day 1 | 0.886 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 11 type antigen, Day 1 | 0.932 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 45 type antigen, Month 2 | 0.805 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 7 | 0.842 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 31 type antigen, Month 3 | 0.845 Correlation coefficient |
| Gar9 Group | Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers | HPV 58 type antigen, Month 2 | 0.803 Correlation coefficient |
Secondary
Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of each vaccine dose and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 3 | 188 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 2 | 68 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 3 | 59 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 2 | 208 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 1 | 61 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 1 | 71 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 3 | 61 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 2 | 79 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 1 | 240 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 2 | 83 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 3 | 191 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 2 | 55 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 1 | 70 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 1 | 244 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 1 | 54 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 3 | 52 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 3 | 64 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 2 | 221 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 2 | 69 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 1 | 245 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 1 | 91 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 1 | 66 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 2 | 218 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 2 | 59 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 3 | 191 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 3 | 64 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 3 | 58 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 3 | 155 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 2 | 185 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 1 | 21 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 3 | 24 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 3 | 37 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 1 | 47 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any swelling, post-dose 2 | 35 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any redness, post-dose 2 | 46 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Administration Site Events | Any pain, post-dose 1 | 188 Participants |
Secondary
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever (defined as body temperature \>=37.5°C/99.5°F), headache, myalgia, arthralgia and fatigue. The preferred location for measuring temperature was the axilla. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Time frame: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of each vaccine dose and for whom data were available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 1 | 15 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 3 | 106 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 2 | 25 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 1 | 87 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 2 | 152 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 3 | 13 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 1 | 27 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 1 | 137 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 3 | 21 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 1 | 180 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 2 | 8 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 3 | 61 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 2 | 113 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 3 | 122 Participants |
| HPV9 High Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 2 | 80 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 2 | 67 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 3 | 81 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 1 | 166 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 2 | 19 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 1 | 113 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 3 | 11 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 3 | 59 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 2 | 132 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 1 | 105 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 2 | 106 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 3 | 103 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 3 | 15 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 2 | 13 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 1 | 25 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 1 | 12 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 2 | 66 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 1 | 10 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 1 | 131 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 1 | 92 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 1 | 22 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 1 | 146 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 2 | 9 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 2 | 118 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 2 | 21 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 2 | 124 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 3 | 11 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 3 | 84 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 3 | 54 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 3 | 19 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 3 | 103 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 2 | 101 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 1 | 127 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any headache, post-dose 3 | 85 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 2 | 16 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 1 | 149 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 1 | 13 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 3 | 45 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 1 | 23 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 1 | 75 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 3 | 102 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fatigue, post-dose 2 | 127 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 2 | 20 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any arthralgia, post-dose 3 | 10 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any fever, post-dose 3 | 8 Participants |
| Gar9 Group | Number of Participants Reporting Any Solicited Systemic Events | Any myalgia, post-dose 2 | 56 Participants |
Secondary
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Time frame: Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of each vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 1 | 70 Participants |
| HPV9 High Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 3 | 37 Participants |
| HPV9 High Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 2 | 51 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 1 | 72 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 3 | 41 Participants |
| HPV9 Med Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 2 | 38 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 2 | 58 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 1 | 70 Participants |
| HPV9 Low Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 3 | 45 Participants |
| Gar9 Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 1 | 70 Participants |
| Gar9 Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 3 | 31 Participants |
| Gar9 Group | Number of Participants Reporting Any Unsolicited AEs | Any unsolicited AEs, post-dose 2 | 55 Participants |
Secondary
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
pIMDs are defined as a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From first vaccination (Day 1) to study end (Month 12)
Population: Analysis was performed on the Exposed set, which included all participants who received a study vaccine and for whom data were available for the specified period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| HPV9 Med Group | Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| HPV9 Low Group | Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| Gar9 Group | Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
Secondary
Number of Participants Reporting Pregnancies
The number of participants who experienced pregnancy while participating in this study is reported.
Time frame: From Day 1 of pregnancy to study end (Month 12)
Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV9 High Group | Number of Participants Reporting Pregnancies | 1 Participants |
| HPV9 Med Group | Number of Participants Reporting Pregnancies | 3 Participants |
| HPV9 Low Group | Number of Participants Reporting Pregnancies | 0 Participants |
| Gar9 Group | Number of Participants Reporting Pregnancies | 5 Participants |
Secondary
Number of Participants With Outcomes of Reported Pregnancies
The participants with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Pregnancy outcomes were live infant, no apparent congenital anomaly; elective termination, no apparent congenital anomaly, and ectopic pregnancy.
Time frame: From Day 1 of pregnancy up to study end (Month 12)
Population: Analysis was performed on the Exposed set, which included all participants who received a study vaccine, who reported any pregnancy and for whom data were available for the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants With Outcomes of Reported Pregnancies | Live infant, no apparent congenital anomaly | 1 Participants |
| HPV9 High Group | Number of Participants With Outcomes of Reported Pregnancies | Ectopic pregnancy | 0 Participants |
| HPV9 High Group | Number of Participants With Outcomes of Reported Pregnancies | Elective termination, no apparent congenital anomaly | 0 Participants |
| HPV9 Med Group | Number of Participants With Outcomes of Reported Pregnancies | Live infant, no apparent congenital anomaly | 2 Participants |
| HPV9 Med Group | Number of Participants With Outcomes of Reported Pregnancies | Ectopic pregnancy | 0 Participants |
| HPV9 Med Group | Number of Participants With Outcomes of Reported Pregnancies | Elective termination, no apparent congenital anomaly | 1 Participants |
| HPV9 Low Group | Number of Participants With Outcomes of Reported Pregnancies | Elective termination, no apparent congenital anomaly | 0 Participants |
| HPV9 Low Group | Number of Participants With Outcomes of Reported Pregnancies | Live infant, no apparent congenital anomaly | 0 Participants |
| HPV9 Low Group | Number of Participants With Outcomes of Reported Pregnancies | Ectopic pregnancy | 0 Participants |
| Gar9 Group | Number of Participants With Outcomes of Reported Pregnancies | Live infant, no apparent congenital anomaly | 2 Participants |
| Gar9 Group | Number of Participants With Outcomes of Reported Pregnancies | Ectopic pregnancy | 1 Participants |
| Gar9 Group | Number of Participants With Outcomes of Reported Pregnancies | Elective termination, no apparent congenital anomaly | 2 Participants |
Secondary
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
Seroconversion is defined as the appearance of antibodies \[i.e., concentration greater than or equal to (\>=) the lower limit of quantification (LLOQ) value\] in the serum of participants seronegative \[i.e, concentrations less than (\<) the LLOQ value\] before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 5100 AU/mL; HPV 11 type: LLOQ = 2480 AU/mL; HPV 16 type: LLOQ = 404 AU/mL; HPV 18 type: LLOQ = 1234 AU/mL; HPV 31 type: LLOQ = 3849 AU/mL; HPV 33 type: LLOQ = 617 AU/mL; HPV 45 type: LLOQ = 4079 AU/mL; HPV 52 type: LLOQ = 2352 AU/mL and HPV 58 type: LLOQ = 660 AU/mL.
Time frame: At Month 2, Month 3, Month 6, Month 7 and Month 12
Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 2 | 186 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 3 | 186 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 6 | 187 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 7 | 179 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 12 | 165 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 2 | 198 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 3 | 192 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 6 | 189 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 7 | 183 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 12 | 177 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 2 | 170 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 3 | 166 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 6 | 161 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 7 | 156 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 12 | 155 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 2 | 187 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 3 | 182 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 6 | 180 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 7 | 174 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 12 | 170 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 2 | 199 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 3 | 192 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 6 | 193 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 7 | 186 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 12 | 178 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 2 | 168 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 3 | 159 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 6 | 153 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 7 | 154 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 12 | 153 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 2 | 190 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 3 | 203 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 6 | 204 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 7 | 192 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 12 | 191 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 2 | 202 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 3 | 196 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 6 | 195 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 7 | 186 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 12 | 180 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 2 | 180 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 3 | 173 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 6 | 172 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 7 | 165 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 12 | 156 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 2 | 186 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 6 | 174 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 2 | 163 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 7 | 170 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 6 | 185 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 2 | 186 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 7 | 185 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 12 | 175 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 3 | 192 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 12 | 164 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 6 | 200 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 2 | 170 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 3 | 189 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 3 | 206 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 2 | 180 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 3 | 166 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 7 | 144 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 2 | 190 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 2 | 198 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 6 | 158 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 7 | 162 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 3 | 181 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 12 | 159 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 7 | 157 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 6 | 182 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 6 | 154 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 2 | 192 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 7 | 176 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 7 | 168 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 12 | 175 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 12 | 170 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 6 | 190 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 12 | 174 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 12 | 147 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 7 | 174 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 6 | 189 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 2 | 192 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 3 | 162 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 12 | 190 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 7 | 172 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 3 | 192 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 3 | 195 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 3 | 197 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 12 | 180 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 6 | 185 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 3 | 195 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 3 | 170 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 6 | 165 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 12 | 151 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 7 | 152 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 12 | 151 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 6 | 187 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 2 | 185 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 3 | 185 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 6 | 178 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 7 | 164 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 7 | 175 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 12 | 163 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 2 | 189 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 7 | 152 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 3 | 191 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 6 | 185 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 12 | 174 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 7 | 170 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 12 | 171 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 2 | 168 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 3 | 166 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 2 | 170 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 6 | 152 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 7 | 148 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 12 | 151 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 2 | 191 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 3 | 170 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 3 | 213 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 6 | 203 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 7 | 189 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 2 | 189 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 3 | 201 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 6 | 191 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 12 | 190 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 7 | 178 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 12 | 174 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 6 | 163 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 2 | 190 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 3 | 191 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 2 | 197 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 6 | 183 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 7 | 169 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 12 | 171 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 2 | 169 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 7 | 188 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 7 | 180 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 6 | 187 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 2 | 137 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 6 | 184 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 3 | 202 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 2 | 194 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 3 | 211 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 2 | 171 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 7 | 173 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 12 | 160 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 6 | 173 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 3 | 172 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 12 | 173 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 7 | 182 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 7 | 186 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 12 | 184 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 7 | 170 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 6 | 168 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 6 type antigen, Month 12 | 172 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 7 | 157 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 6 | 177 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 2 | 177 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 2 | 208 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 3 | 192 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 7 | 156 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 12 | 164 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 2 | 186 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 6 | 182 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 12 | 161 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 6 | 157 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 3 | 172 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 12 | 184 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 2 | 122 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 11 type antigen, Month 3 | 206 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 33 type antigen, Month 2 | 179 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 16 type antigen, Month 6 | 164 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 3 | 212 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 3 | 180 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 58 type antigen, Month 7 | 161 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 18 type antigen, Month 2 | 187 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 45 type antigen, Month 6 | 179 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 31 type antigen, Month 12 | 178 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 12 | 175 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV IgG Antibodies | HPV 52 type antigen, Month 3 | 194 Participants |
Secondary
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
Seroconversion is defined as the appearance of antibodies (i.e., titer \>=LLOQ value) in the serum of participants seronegative (i.e, titer \<LLOQ value) before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 269 titers; HPV 11 type: LLOQ = 279 titers; HPV 16 type: LLOQ = 339 titers; HPV 18 type: LLOQ = 84 titers; HPV 31 type: LLOQ = 96 titers; HPV 33 type: LLOQ = 323 titers; HPV 45 type: LLOQ = 76 titers; HPV 52 type: LLOQ = 104 titers and HPV 58 type: LLOQ = 95 titers.
Time frame: At Month 3 and Month 7
Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 3 | 186 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 7 | 120 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 7 | 126 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 7 | 122 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 3 | 204 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 3 | 195 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 3 | 185 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 7 | 136 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 3 | 172 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 7 | 130 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 3 | 193 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 3 | 187 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 7 | 124 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 3 | 192 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 7 | 112 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 7 | 120 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 7 | 129 Participants |
| HPV9 High Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 3 | 189 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 7 | 109 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 7 | 111 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 3 | 188 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 7 | 107 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 3 | 185 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 3 | 184 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 3 | 184 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 3 | 206 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 7 | 109 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 7 | 114 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 7 | 111 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 7 | 121 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 3 | 196 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 7 | 119 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 3 | 188 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 3 | 199 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 7 | 118 Participants |
| HPV9 Med Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 3 | 179 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 7 | 118 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 3 | 181 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 7 | 116 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 3 | 198 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 7 | 128 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 3 | 187 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 7 | 114 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 3 | 193 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 7 | 120 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 3 | 186 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 7 | 116 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 3 | 210 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 7 | 135 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 3 | 189 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 7 | 119 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 3 | 189 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 3 | 190 Participants |
| HPV9 Low Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 7 | 118 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 3 | 192 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 7 | 119 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 7 | 116 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 7 | 120 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 6 type antigen, Month 3 | 192 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 3 | 193 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 18 type antigen, Month 3 | 195 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 7 | 121 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 16 type antigen, Month 3 | 196 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 52 type antigen, Month 7 | 116 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 7 | 127 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 11 type antigen, Month 3 | 206 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 7 | 116 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 7 | 131 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 33 type antigen, Month 3 | 215 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 58 type antigen, Month 3 | 193 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 45 type antigen, Month 3 | 186 Participants |
| Gar9 Group | Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies | HPV 31 type antigen, Month 7 | 118 Participants |