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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000090-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV9 High Group | Experimental | 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. |
|
| HPV9 Med Group | Experimental | 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. |
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| HPV9 Low Group | Experimental | 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. |
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| Gar9 Group | Active Comparator | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV9 High formulation | Biological | 3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 7 days after vaccine Dose 1 (administered at Day 1) |
| 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. | Within 7 days after vaccine Dose 2 (administered at Month 2) |
| 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. | Within 7 days after vaccine Dose 3 (administered at Month 6) |
| 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. | Within 7 days after vaccine Dose 1 (administered at Day 1) |
| Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
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Inclusion Criteria:
Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria:
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
History or current diagnosis of autoimmune disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
Major congenital defects, as assessed by the investigator.
History of abnormal Papanicolaou test or abnormal cervical biopsy result.
History of external genital/vaginal warts.
History of positive HPV test.
Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Previous vaccination against HPV.
Previous exposure to monophosphoryl lipid A (MPL) or AS04 adjuvant.
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.
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.
Administration of long-acting immune-modifying drugs at any time during the study period.
Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period.
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.
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.
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.
History of /current chronic alcohol consumption and/or drug abuse.
Any study personnel or their immediate dependents, family, or household members.
Child in care.
Only female participants, between 16-26 years of age were included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92103-6204 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | HPV9 Med Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Dec 12, 2024 |
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Observer-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine
| HPV9 Medium formulation | Biological | 3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. |
|
| HPV9 Low formulation | Biological | 3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6. |
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| Gardasil 9 | Biological | 3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and 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. |
| Within 7 days after vaccine Dose 2 (administered at Month 2) |
| 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. | Within 7 days after vaccine Dose 3 (administered at Month 6) |
| 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. | Within 28 days after vaccine Dose 1 (administered at Day 1) |
| 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. | Within 28 days after vaccine Dose 2 (administered at Month 2) |
| 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. | Within 28 days after vaccine Dose 3 (administered at Month 6) |
| 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. | From first vaccination (Day 1) to study end (Month 12) |
| 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. | At Day 7 |
| 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. | At Day 7 |
| 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. | At Day 7 compared to baseline (Day 1) |
| 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. | At Month 7 (one month after vaccine Dose 3 administration) |
| 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. |
| Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
| 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. | Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
| 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. | From first vaccination (Day 1) to study end (Month 12) |
| Number of Participants Reporting Pregnancies | The number of participants who experienced pregnancy while participating in this study is reported. | From Day 1 of pregnancy to study end (Month 12) |
| 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. | From Day 1 of pregnancy up to study end (Month 12) |
| 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. | 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 |
| 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. | At Month 2, Month 3, Month 6, Month 7 and Month 12 |
| 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. | At Day 1, Month 3 and Month 7 |
| 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. | At Month 2 |
| 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 \ | At Month 3 and Month 7 |
| 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. | At Day 1, Month 2, Month 3 and Month 7 |
| San Diego |
| California |
| 92120 |
| United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Kissimmee | Florida | 34741 | United States |
| GSK Investigational Site | Miami | Florida | 33125 | United States |
| GSK Investigational Site | North Miami Beach | Florida | 33162 | United States |
| GSK Investigational Site | Pompano Beach | Florida | 33060 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30328 | United States |
| GSK Investigational Site | Evansville | Indiana | 47712 | United States |
| GSK Investigational Site | South Bend | Indiana | 46617 | United States |
| GSK Investigational Site | Topeka | Kansas | 66606 | United States |
| GSK Investigational Site | Wichita | Kansas | 67205 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Elkridge | Maryland | 21075 | United States |
| GSK Investigational Site | Saginaw | Michigan | 48602 | United States |
| GSK Investigational Site | Jefferson City | Missouri | 65109 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89102 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Columbus | Ohio | 43213 | United States |
| GSK Investigational Site | Norman | Oklahoma | 73072 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29405 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| GSK Investigational Site | Carrollton | Texas | 75010 | United States |
| GSK Investigational Site | Corpus Christi | Texas | 78412 | United States |
| GSK Investigational Site | Dallas | Texas | 75251 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77065 | United States |
| GSK Investigational Site | Humble | Texas | 77338 | United States |
| GSK Investigational Site | Humble | Texas | 77346 | United States |
| GSK Investigational Site | Irving | Texas | 75062 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Tomball | Texas | 77375 | United States |
| GSK Investigational Site | West Jordan | Utah | 84088 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Norfolk | Virginia | 68701 | United States |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Sofia | 1606 | Bulgaria |
| GSK Investigational Site | Hradec Králové | CZ-500 03 | Czechia |
| GSK Investigational Site | Olomouc | 772 00 | Czechia |
| GSK Investigational Site | Olomouc | 779 00 | Czechia |
| GSK Investigational Site | Prague | 160000 | Czechia |
| GSK Investigational Site | Tallinn | 10128 | Estonia |
| GSK Investigational Site | Tallinn | 10617 | Estonia |
| GSK Investigational Site | Tartu | 50106 | Estonia |
| GSK Investigational Site | Tartu | 50708 | Estonia |
| GSK Investigational Site | Dijon | 21000 | France |
| GSK Investigational Site | La Roche-sur-Yon | 85025 | France |
| GSK Investigational Site | La Tronche | 38043 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Rennes | 35000 | France |
| GSK Investigational Site | Tours | 37000 | France |
| GSK Investigational Site | Schwerin | 19055 | Germany |
| GSK Investigational Site | Würzburg | 97074 | Germany |
| GSK Investigational Site | Kaunas | 49387 | Lithuania |
| GSK Investigational Site | Kaunas | LT-48259 | Lithuania |
| GSK Investigational Site | Kaunas | LT-49456 | Lithuania |
| GSK Investigational Site | Kaunas | LT-50177 | Lithuania |
| GSK Investigational Site | Vilnius | 8661 | Lithuania |
| GSK Investigational Site | Bydgoszcz | 85-796 | Poland |
| GSK Investigational Site | Krakow | 30-348 | Poland |
| GSK Investigational Site | Lodz | 91-363 | Poland |
| GSK Investigational Site | Skierniewice | 96-100 | Poland |
| GSK Investigational Site | Warsaw | 00-215 | Poland |
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.
| FG002 | 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. |
| FG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 1 (administered at Day 1) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 2 (administered at Month 2) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 3 (administered at Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 1 (administered at Day 1) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 2 (administered at Month 2) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after vaccine Dose 3 (administered at Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 28 days after vaccine Dose 1 (administered at Day 1) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 28 days after vaccine Dose 2 (administered at Month 2) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 28 days after vaccine Dose 3 (administered at Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | From first vaccination (Day 1) to study end (Month 12) |
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| 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. | 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. | Posted | Count of Participants | Participants | At Day 7 |
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| 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. | 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. | Posted | Count of Participants | Participants | At Day 7 |
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| 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. | 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. | Posted | Count of Participants | Participants | At Day 7 compared to baseline (Day 1) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | At Month 7 (one month after vaccine Dose 3 administration) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6) |
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| 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. | 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. | Posted | Count of Participants | Participants | From first vaccination (Day 1) to study end (Month 12) |
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| Secondary | Number of Participants Reporting Pregnancies | The number of participants who experienced pregnancy while participating in this study is reported. | 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. | Posted | Count of Participants | Participants | From Day 1 of pregnancy to study end (Month 12) |
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| 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. | 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. | Posted | Count of Participants | Participants | From Day 1 of pregnancy up to study end (Month 12) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | 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 |
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| 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. | 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. | Posted | Count of Participants | Participants | At Month 2, Month 3, Month 6, Month 7 and Month 12 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1, Month 3 and Month 7 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 2 |
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| 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 \ | 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. | Posted | Count of Participants | Participants | At Month 3 and Month 7 |
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| 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. | 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. | Posted | Number | Correlation coefficient | At Day 1, Month 2, Month 3 and Month 7 |
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Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 270 | 1 | 270 | 260 | 270 |
| EG001 | 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. | 0 | 270 | 4 | 270 | 265 | 270 |
| EG002 | 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. | 0 | 269 | 2 | 269 | 262 | 269 |
| EG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. | 0 | 270 | 7 | 270 | 254 | 270 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Appendiceal abscess | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Bartholin's abscess | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Chronic tonsillitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
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| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v27.0 | Systematic Assessment |
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| Affective disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
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| Personality disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
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| Gastric bypass | Surgical and medical procedures | MedDRA v27.0 | Systematic Assessment |
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| Nasal septal operation | Surgical and medical procedures | MedDRA v27.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
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| Ear inflammation | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v27.0 | Systematic Assessment |
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| Autoimmune thyroiditis | Endocrine disorders | MedDRA v27.0 | Systematic Assessment |
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| Polycystic ovarian syndrome | Endocrine disorders | MedDRA v27.0 | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA v27.0 | Systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA v27.0 | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Administration site erythema | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Administration site pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Administration site swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Induration | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site granuloma | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Vaccination site bruising | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Vaccination site induration | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Vaccination site nodule | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Vaccination site pain | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vaccination site pruritus | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vaccination site swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Enterovirus infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Infectious mononucleosis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Lyme disease | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Human papilloma virus test positive | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Thoracic radiculopathy | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Other symptoms/illnesses or reactions | General disorders | MedDRA v27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2024 | Dec 12, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D007239 | Infections |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Grade 3 Redness |
|
| Grade 3 Swelling |
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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.
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG002 | 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG002 | 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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.
| OG002 | 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG002 |
| 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG002 |
| 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
| OG003 |
| Gar9 Group |
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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. |
| OG002 | 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. |
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
|
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.
| OG003 | Gar9 Group | Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6. |
|
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