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Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix & Engerix Group | Active Comparator | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) co-administered with Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
|
| Cervarix Group | Experimental | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. |
|
| Engerix Group | Active Comparator | Subjects received 3 doses of Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine (GSK580299) Cervarix TM | Biological | IM administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL. | Month 7 |
| Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | Month 7 |
| Anti-HPV-16/18 Antibody Titres | Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL. | Month 7 |
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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 | Nijmegen | 6525 GA | Netherlands | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Schmeink C et al. Co-administration of AS04-adjuvanted human papillomavirus-16/18 vaccine with hepatitis B vaccine in healthy female subjects aged 9-15 years. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010. | ||
| 21856349 | Background | Schmeink CE, Bekkers RL, Josefsson A, Richardus JH, Berndtsson Blom K, David MP, Dobbelaere K, Descamps D. Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls. Vaccine. 2011 Nov 15;29(49):9276-83. doi: 10.1016/j.vaccine.2011.08.037. Epub 2011 Aug 19. | |
| 41276263 |
| 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 |
|---|---|---|---|
| 111507 | Informed Consent Form | 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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While the total numbers of subjects enrolled in the study was 744, the total number of subjects that entered the study was 741. The remaining 3 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix&Engerix Group | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) co-administered with Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
| FG001 | Cervarix Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Engerix B | Biological | IM administration |
|
| Anti-HBs Antibody Titres | Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL. Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. | Month 7 |
| Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | Month 2 |
| Anti-HPV-16/18 Antibody Titres | Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | Month 2 |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL. | Month 2 |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL. | Month 2 |
| Anti-HBs Antibody Titers | Anti-HBs antibody titers are given as GMTs in mIU/mL. Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. | Month 2 |
| Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms included injection site pain, redness and swelling. Any solicited local symptom is occurence of a symptom regardless of its intensity. | During the 7-day period (Days 0 - 6) following vaccination |
| Number of Subjects Reporting Grade 3 Solicited Local Symptoms | Solicited local symptoms include injection site pain, redness and swelling. Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm. | During the 7-day period (Days 0-6) following vaccination |
| Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination. | During the 7-day (Days 0-6) period following vaccination. |
| Number of Subjects Reporting Grade 3 Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity. Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas. | During the 7-day (Days 0-6) period following vaccination |
| Number of Subjects Reporting Related Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination. | During the 7-day period (Days 0 - 6) following vaccination |
| Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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. Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination. | During the 30-day period (Days 0 - 29) following any vaccination |
| Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs were SAEs assessed by the investigators as related to the vaccination. * Grade 3 SAEs were not assessed. | Throughout the active phase of the study (up to Month 7). |
| Number of Subjects Reporting Any and Causally Related to Vaccination SAEs | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. * Grade 3 SAEs were not assessed. | Throughout the safety follow-up (month 7 up to Month 12). |
| Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases). | Throughout the active phase of the study (up to Month 7) |
| Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases). | Throughout the safety follow-up (month 7 up to Month 12) |
| Rotterdam |
| 3011 EN |
| Netherlands |
| GSK Investigational Site | Linköping | SE-581 85 | Sweden |
| GSK Investigational Site | Luleå | SE-972 31 | Sweden |
| GSK Investigational Site | Malmö | SE-211 52 | Sweden |
| GSK Investigational Site | Norrköping | SE-601 82 | Sweden |
| GSK Investigational Site | Skene | SE-511 62 | Sweden |
| 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 |
| 111507 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111507 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111507 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111507 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111507 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111507 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
| FG002 | Engerix Group | Subjects received 3 doses of Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix&Engerix Group | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) co-administered with Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
| BG001 | Cervarix Group | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. |
| BG002 | Engerix Group | Subjects received 3 doses of Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 7 |
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| Primary | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 7 |
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| Primary | Anti-HPV-16/18 Antibody Titres | Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Month 7 |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 7 |
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| Secondary | Anti-HBs Antibody Titres | Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL. Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Month 7 |
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| Secondary | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 2 |
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| Secondary | Anti-HPV-16/18 Antibody Titres | Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Month 2 |
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| Secondary | Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 2 |
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| Secondary | Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection | Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Month 2 |
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| Secondary | Anti-HBs Antibody Titers | Anti-HBs antibody titers are given as GMTs in mIU/mL. Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination. | The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Month 2 |
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| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms included injection site pain, redness and swelling. Any solicited local symptom is occurence of a symptom regardless of its intensity. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period (Days 0 - 6) following vaccination |
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| Secondary | Number of Subjects Reporting Grade 3 Solicited Local Symptoms | Solicited local symptoms include injection site pain, redness and swelling. Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period (Days 0-6) following vaccination |
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| Secondary | Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) period following vaccination. |
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| Secondary | Number of Subjects Reporting Grade 3 Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity. Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) period following vaccination |
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| Secondary | Number of Subjects Reporting Related Solicited General Symptoms | Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria. Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period (Days 0 - 6) following vaccination |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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. Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 30-day period (Days 0 - 29) following any vaccination |
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| Secondary | Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs were SAEs assessed by the investigators as related to the vaccination. * Grade 3 SAEs were not assessed. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Throughout the active phase of the study (up to Month 7). |
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| Secondary | Number of Subjects Reporting Any and Causally Related to Vaccination SAEs | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. * Grade 3 SAEs were not assessed. | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Throughout the safety follow-up (month 7 up to Month 12). |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases). | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Throughout the active phase of the study (up to Month 7) |
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| Secondary | Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases). | Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Throughout the safety follow-up (month 7 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&Engerix Group | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) co-administered with Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. | 3 | 247 | 246 | 247 | ||
| EG001 | Cervarix Group | Subjects received 3 doses of Cervarixâ„¢ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. | 2 | 247 | 239 | 247 | ||
| EG002 | Engerix Group | Subjects received 3 doses of Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. | 1 | 247 | 222 | 247 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | MedRa | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedRa | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastrointestinal | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Myalgia | General disorders | Systematic Assessment |
| ||
| Rash | General disorders | Systematic Assessment |
| ||
| Temperature | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Oropharyngeal pain | General disorders | Non-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 |
| D002583 | Uterine Cervical Neoplasms |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
Subjects received 3 doses of Engerixâ„¢ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
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