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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003766-14 | EudraCT Number |
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Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV-16/18 Group | Active Comparator | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-TETRA A Group | Experimental | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-TETRA B Group | Experimental | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-TETRA C Group | Experimental | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-TETRA D Group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV 16/18 L1 AS04 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 | Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At Month 7 |
| Number of Seroconverted Subjects for Anti-HPV-18 at Month 7 | Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL. | At Month 7 |
| Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7 | Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL. | At Month 7 |
| Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7 | Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | At Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HPV-16 at Month 2 | Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL. | At Month 2 |
| Number of Seroconverted Subjects for Anti-HPV-18 at Month 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aurora | Colorado | 80045 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24674663 | Background | Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 102115 | Dataset Specification | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD is available via the Clinical Study Data Request site (click on the link provided below).
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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| ID | Title | Description |
|---|---|---|
| FG000 | HPV-16/18 Group | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| FG001 | HPV-TETRA A Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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This study was performed in a double-blinded manner. Blinding was maintained for all subjects and investigators and their study staff participating in this study with regard to the individual subject treatment (vaccine treatment) assignments allocated in this study.
GSK personnel directly involved in the conduct of this study were also blinded to the subjects' treatment assignments.
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
| HPV-TETRA E Group | Experimental | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-TETRA F Group | Experimental | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 1 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 2 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 3 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 4 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 5 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
| HPV-16/18/31/45 L1 AS04 Formulation 6 | Biological | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
|
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL. |
| At Month 2 |
| Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2 | Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | At Month 2 |
| Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2 | Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | At Month 2 |
| Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7 | Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL. | At Month 2 and Month 7 |
| Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7 | Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL. | At Month 2 and Month 7 |
| Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7 | Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | At Month 2 and Month 7 |
| Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7 | Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | At Month 2 and Month 7 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study. | During the 7 day post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination. | During the 7 day post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination. | During the 30-day post-vaccination period |
| Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | From Day 0 to Month 7 |
| Number of Subjects With Any SAEs During the Extended Safety Follow-up | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | From Day 0 to Month 12 |
| Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion. | From Day 0 to Month 12 |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) | NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases. | From Day 0 up to Month 12 |
| Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. | From Day 0 up to Month 12 |
| Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter. | At Month 2 and Month 7 |
| Golden |
| Colorado |
| 80401 |
| United States |
| GSK Investigational Site | Kingston | Rhode Island | 02881 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | United States |
| GSK Investigational Site | Brussels | 1070 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Roeselare | 8800 | Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102115 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102115 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102115 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 102115 are summarised with studies 107919 and 108052 on the GSK Clinical Study Register. |
| 102115 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102115 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
| FG002 | HPV-TETRA B Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| FG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| FG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| FG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| FG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HPV-16/18 Group | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG001 | HPV-TETRA A Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG002 | HPV-TETRA B Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| BG007 | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 | Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 7 |
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| Primary | Number of Seroconverted Subjects for Anti-HPV-18 at Month 7 | Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 7 |
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| Primary | Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7 | Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 7 |
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| Primary | Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7 | Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 7 |
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| Secondary | Number of Seroconverted Subjects for Anti-HPV-16 at Month 2 | Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 2 |
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| Secondary | Number of Seroconverted Subjects for Anti-HPV-18 at Month 2 | Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 2 |
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| Secondary | Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2 | Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 2 |
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| Secondary | Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2 | Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 2 |
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| Secondary | Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7 | Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 2 and Month 7 |
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| Secondary | Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7 | Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Month 2 and Month 7 |
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| Secondary | Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7 | Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 2 and Month 7 |
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| Secondary | Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7 | Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 2 and Month 7 |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study. | The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed. | Posted | Count of Participants | Participants | During the 7 day post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed. | Posted | Count of Participants | Participants | During the 7 day post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | During the 30-day post-vaccination period |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any SAEs During the Extended Safety Follow-up | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) | NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available. | Posted | Count of Participants | Participants | From Day 0 up to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available at the specified time points. | Posted | Count of Participants | Participants | At Month 2 and Month 7 |
|
Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
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 | HPV-16/18 Group | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 88 | 2 | 88 | 81 | 88 |
| EG001 | HPV-TETRA A Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 50 | 2 | 50 | 48 | 50 |
| EG002 | HPV-TETRA B Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 49 | 1 | 49 | 46 | 49 |
| EG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 48 | 3 | 48 | 45 | 48 |
| EG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 48 | 2 | 48 | 44 | 48 |
| EG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 50 | 0 | 50 | 50 | 50 |
| EG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. | 0 | 50 | 0 | 50 | 47 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Myelitis | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Redness* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Swelling* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Arthralgia* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Fatigue* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Fever* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Gastrointestinal* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Headache (solicited)* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Myalgia* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Rash* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Urticaria* | General disorders | MedDRA 9.0 | Systematic Assessment | *Solicited symptom during the 7-day post-vaccination period (across doses) |
|
| Diarrhea** | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Nausea** | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Toothache** | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Injection site pruritus** | General disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Injection site reaction** | General disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Cystitis** | Infections and infestations | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Influenza** | Infections and infestations | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Nasopharyngitis** | Infections and infestations | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Upper respiratory tract infection** | Infections and infestations | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Dizziness** | Nervous system disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Headache (unsolicited)** | Nervous system disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Dysmenorhoea** | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Pharyngolaryngeal Pain** | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
| Rhinitis** | Infections and infestations | MedDRA 9.0 | Systematic Assessment | **Unsolicited symptom during the 30-day post-vaccination period (across doses) |
|
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 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| White/caucasian |
|
| Arabic/north african |
|
| East/south east asian |
|
| South asian |
|
| American hispanic |
|
| Japanese |
|
| Other, not specified |
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| OG002 | HPV-TETRA B Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
|
|
| HPV-TETRA B Group |
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| HPV-TETRA C Group |
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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| HPV-TETRA B Group |
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG003 | HPV-TETRA C Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG004 | HPV-TETRA D Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG005 | HPV-TETRA E Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| OG006 | HPV-TETRA F Group | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
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