Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
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Purpose
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
| Condition | Intervention | Phase |
|---|---|---|
|
Human Papillomavirus Infection |
Procedure: Blood sampling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (580299) in Healthy Female Subjects |
- Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: at Month 60 ] [ Designated as safety issue: No ]Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
- Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: at month 72 ] [ Designated as safety issue: No ]Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
- Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Months 96, 108 and 120 ] [ Designated as safety issue: No ]Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
- Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: at Month 72 ] [ Designated as safety issue: No ]
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
- Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: at Month 60 ] [ Designated as safety issue: No ]
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
- Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Months 96, 108 and 120 ] [ Designated as safety issue: No ]
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subjects is a subject with antibody titer < 8 or 7 EL.U/mL) prior to vaccination.
A seropositive subjects is a subject with antibody titer >= 8 or 7 EL.U/mL) prior to vaccination.
- Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Month 84 ] [ Designated as safety issue: No ]Note: Results for humoral immune response to HPV will be updated when validated results become available.
- Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Month 84 ] [ Designated as safety issue: No ]Note: Results for humoral immune response to HPV will be updated when validated results become available.
- Anti-HPV-16/18 Antibody Titers in Efficacy Studies NCT00689741/NCT00120848/NCT00518336 [ Time Frame: at Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]Titers were expressed as Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL).
- Number of Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values in Efficacy Studies NCT00689741/NCT00120848/NCT00518336 [ Time Frame: at Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]Cut-offs were defined as 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.
- Anti-HPV-16/18 Antibody Titers Elicited After Natural Infection (Study 580299/008 (NCT00122681)) [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
Titer was expressed as GMT in EL.U/mL.
Subjects included had a natural infection and were seropositive for HPV-16 or 18 at Month 0 and HPV DNA negative for the antigen, which meant they had successfully cleared the infection and mounted an immune response.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: from Month 48 to Month 60 ] [ Designated as safety issue: No ]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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: from Month 60 to Month 72 ] [ Designated as safety issue: No ]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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 72 to Month 84 ] [ Designated as safety issue: No ]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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: from Month 48 to Month 120 ] [ Designated as safety issue: No ]
| Enrollment: | 529 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | January 2015 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cervarix Group
Subjects in the Cervarix Group in the primary study (NCT00196924) who received 3 doses of Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule
|
Procedure: Blood sampling
Blood samples will be collected at Months 60, 72, 84, 96, 108 and 120
|
Detailed Description:
Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study.
Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.
Eligibility| Ages Eligible for Study: | 15 Years to 24 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
- A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
- Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.
Exclusion Criteria:
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
- Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
Contacts and Locations| Colombia | |
| GSK Investigational Site | |
| Bogota, Colombia | |
| Germany | |
| GSK Investigational Site | |
| Deggingen, Baden-Wuerttemberg, Germany, 73326 | |
| GSK Investigational Site | |
| Ettenheim, Baden-Wuerttemberg, Germany, 77955 | |
| GSK Investigational Site | |
| Kehl, Baden-Wuerttemberg, Germany, 77694 | |
| GSK Investigational Site | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| GSK Investigational Site | |
| Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941 | |
| GSK Investigational Site | |
| Weilheim, Bayern, Germany, 82362 | |
| GSK Investigational Site | |
| Wuerzburg, Bayern, Germany, 97070 | |
| GSK Investigational Site | |
| Buetzow, Mecklenburg-Vorpommern, Germany, 18246 | |
| GSK Investigational Site | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18109 | |
| GSK Investigational Site | |
| Wolfenbuettel, Niedersachsen, Germany, 38302 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44866 | |
| GSK Investigational Site | |
| Willich, Nordrhein-Westfalen, Germany, 47877 | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54290 | |
| GSK Investigational Site | |
| Flensburg, Schleswig-Holstein, Germany, 24937 | |
| GSK Investigational Site | |
| Harrislee, Schleswig-Holstein, Germany, 24955 | |
| GSK Investigational Site | |
| Weimar, Thueringen, Germany, 99425 | |
| GSK Investigational Site | |
| Berlin, Germany, 10315 | |
| GSK Investigational Site | |
| Berlin, Germany, 10967 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22307 | |
| Honduras | |
| GSK Investigational Site | |
| Tegucigalpa, Francisco Morazan, Honduras, 11101 | |
| Panama | |
| GSK Investigational Site | |
| Arraijan/Vista Alegre, Panamá, Panama | |
| GSK Investigational Site | |
| La Chorrera, Panamá, Panama | |
| Taiwan | |
| GSK Investigational Site | |
| Taipei, Taiwan, 100 | |
| GSK Investigational Site | |
| Taoyuan, Taiwan, 333 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00877877 History of Changes |
| Other Study ID Numbers: | 111375 |
| Study First Received: | March 26, 2009 |
| Results First Received: | March 31, 2011 |
| Last Updated: | June 6, 2013 |
| Health Authority: | Colombia: INVIMA Taiwan: Department of Health Honduras: UNAH Panama: Instituto Conmemorativo Gorgas de Estudios de la Salud. Comité Nacional de Bioética de la Investigación Germany: Paul-Ehrlich-Institut |
Keywords provided by GlaxoSmithKline:
|
HPV vaccine cervical cancer |
Additional relevant MeSH terms:
|
Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral |
Tumor Virus Infections Neoplasms Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013