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| ID | Type | Description | Link |
|---|---|---|---|
| 104902 | Other Identifier | GSK | |
| 104904 | Other Identifier | GSK | |
| 104918 | Other Identifier | GSK |
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This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).
The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarixâ„¢) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. |
|
| Havrix Group | Active Comparator | Subjects received 3 doses of Havrixâ„¢ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' HPV-16/18 Vaccine (Cervarixâ„¢) | Biological | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | At 18, 24, 36 and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | At Months 18 and 24 |
| Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up |
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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 | Bogotá | 805 | Colombia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22265115 | Derived | Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004. |
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Subjects from the Cervarix group continued the long-term follow-up study until Month 48 while subjects from the Havrix group completed the study at Month 24.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarixâ„¢) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. |
| FG001 | Havrix Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Havrixâ„¢ | Biological | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule. |
|
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| At Month 36 and 48 |
| Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up | 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. | From Month 18 to Month 24 |
| Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up | Serious adverse events assessed include medical occurrences that result in death, is 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. | From Month 24 to Month 48 |
| Bogotá |
| Colombia |
| GSK Investigational Site | Deggingen | Baden-Wurttemberg | 73326 | Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| GSK Investigational Site | Tauberbischofsheim | Baden-Wurttemberg | 97941 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22307 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Bützow | Mecklenburg-Vorpommern | 18246 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18109 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Brunsbüttel | Schleswig-Holstein | 25541 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Harrislee | Schleswig-Holstein | 24955 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Niebüll | Schleswig-Holstein | 25899 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10967 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
| GSK Investigational Site | Comayagüela | Honduras |
| GSK Investigational Site | La Chorrera | Provincia de Panamá | Panama |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Tao Yuan County | 333 | Taiwan |
Subjects received 3 doses of Havrixâ„¢ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarixâ„¢) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. |
| BG001 | Havrix Group | Subjects received 3 doses of Havrixâ„¢ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. |
| BG002 | 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 | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At 18, 24, 36 and 48 months |
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| Secondary | Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 18 and 24 |
|
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| Secondary | Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 36 and 48 |
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| Secondary | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up | 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. | Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. | Posted | Number | Subjects | From Month 18 to Month 24 |
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| Secondary | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up | Serious adverse events assessed include medical occurrences that result in death, is 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. | Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24. | Posted | Number | Subjects | From Month 24 to Month 48 |
|
From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
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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 | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarixâ„¢) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. | 33 | 626 | 0 | 626 | ||
| EG001 | Havrix Group | Subjects received 3 doses of Havrixâ„¢ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. | 5 | 619 | 0 | 619 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dermoid cyst of ovary | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Premature labor | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Skull fractured base | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Splenic rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Campylobacter gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Helicobacter gastritis | Infections and infestations | Non-systematic Assessment |
| ||
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
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| Ovarian cyst torsion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Acute tonsilitis | Infections and infestations | Non-systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
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| Investigation | Investigations | Non-systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Malocclusion | Gastrointestinal disorders | Non-systematic Assessment |
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| Meningitis viral | Infections and infestations | Non-systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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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 |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Anti-HPV-16 at Month 48 (n= 559) |
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| Anti-HPV-18 at Month 18 (n= 587) |
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| Anti-HPV-18 at Month 24 (n= 548) |
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| Anti-HPV-18 at Month 36 (n= 570) |
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| Anti-HPV-18 at Month 48 (n= 559) |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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