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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000416-42 | EudraCT Number |
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Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7 and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8 per 100 000; Middle Africa 28.0 and 23.0 per 100 000).
As in the majority of developing countries, organization of cervical cancer screening programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic vaccination could therefore clearly and efficiently decrease the incidence of cervical cancer. The current study is designed to assess the immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in Africa.
Ideally, HPV vaccination should be performed before onset of sexual activity, since studies have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will therefore be performed in subjects aged 10 to 25 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Active Comparator | Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
|
| Placebo Group | Placebo Comparator | Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix | Biological | The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | At Month 7 |
| Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | At Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. |
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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 | Dakar | Senegal | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kiviat N et al. Immunisation of African pre-teen/adolescent girls and young women with the HPV-16/18 AS04-adjuvanted vaccine. Abstract presented at South African Society of Obstetricians and Gynaecologists - O & G Update 2011. Pretoria, South Africa, 5-7 May 2011. | ||
| 23242542 | Background | Sow PS, Watson-Jones D, Kiviat N, Changalucha J, Mbaye KD, Brown J, Bousso K, Kavishe B, Andreasen A, Toure M, Kapiga S, Mayaud P, Hayes R, Lebacq M, Herazeh M, Thomas F, Descamps D. Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women. J Infect Dis. 2013 Jun 1;207(11):1753-63. doi: 10.1093/infdis/jis619. Epub 2012 Dec 13. | |
| Background | Sow PS. et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in African preteen/adolescent girls and young women. Abstract presented at the African Organisation for Research and Training in Cancer (AORTIC). Cairo, Egypt, November 30 - December 3, 2011. |
| 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 |
|---|---|---|---|
| 106069 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo Al(OH)3 | Drug | Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm. |
|
| At Month 2 and Month 12 |
| GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | At Month 2 and Month 12 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity. | Within 7 days (Day 0-6) after each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | Within 7 days (Day 0-6) after each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination. | Within 30 days (Day 0-29) after any vaccination |
| Number of Subjects With NOCDs and Other MSCs | New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | From Day 0 up to Month 7 and from Month 7 up to Month 12 |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | From Day 0 up to Month 7 and from Month 7 up to Month 12 |
| Number of Subjects With Pregnancies and Their Outcomes | Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly. | From Day 0 up to Month 12 |
| Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | At Month 7 |
| Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | At Month 7 |
| Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | At Month 12 |
| Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | At Month 12 |
| Mwanza |
| Tanzania |
| 23486859 | Background | Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjose S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13. |
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106069 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Placebo Group |
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
| BG001 | Placebo Group | Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. |
| BG002 | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Count of Participants | Participants | At Month 7 |
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| Primary | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | 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 and Anti-HPV-18 Antibodies | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Count of Participants | Participants | At Month 2 and Month 12 |
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| Secondary | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 2 and Month 12 |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 7 days (Day 0-6) after each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 7 days (Day 0-6) after 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 AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 30 days (Day 0-29) after any vaccination |
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| Secondary | Number of Subjects With NOCDs and Other MSCs | New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From Day 0 up to Month 7 and from Month 7 up to Month 12 |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From Day 0 up to Month 7 and from Month 7 up to Month 12 |
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| Secondary | Number of Subjects With Pregnancies and Their Outcomes | Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly. | The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes). | Posted | Count of Participants | Participants | From Day 0 up to Month 12 |
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| Secondary | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results. | Posted | Count of Participants | Participants | At Month 7 |
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| Secondary | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results. | Posted | Count of Participants | Participants | At Month 7 |
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| Secondary | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results. | Posted | Count of Participants | Participants | At Month 12 |
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| Secondary | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. | The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results. | Posted | Count of Participants | Participants | At Month 12 |
|
Solicited local and general symptoms: within 7 days (Day 0-6) after vaccination; Unsolicited AEs: within 30 days (Day 0-29) after any vaccination; SAEs: during the whole study period (from Day 0 up to Month 12).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervarix Group | Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. | 0 | 450 | 17 | 450 | 433 | 450 |
| EG001 | Placebo Group | Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. | 0 | 226 | 14 | 226 | 216 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Burn infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neuropathy vitamin b6 deficiency | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyomyositis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Adenoiditis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cutaneous larva migrans | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye allergy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hookworm infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Human bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Shigella infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Trichuriasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 13.1 | 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 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| 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 |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
Not provided
Not provided
Not provided
| Male |
|
| Not specified |
|
| 15-25 years anti-HPV-16 |
|
|
| 10-14 years anti-HPV-18 |
|
|
| 15-25 years anti-HPV-18 |
|
|
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