Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.

Infections, Papillomavirus Clinical Trial

Official title:

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877877
• Other study ID #: 111375
• Secondary ID: 2008-000369-44
• Status: Completed
• Phase: Phase 3
• Start date: May 7, 2009
• Est. completion date: January 6, 2015

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: January 6, 2015
• Est. primary completion date: January 6, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Papillomavirus
• Papillomavirus Vaccines

Intervention

Procedure:
• Blood sampling
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120

Locations

Country	Name	City	State
Colombia	GSK Investigational Site	Bogota
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Buetzow	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Harrislee	Schleswig-Holstein
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Niebuell	Schleswig-Holstein
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Tauberbischofsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Weilheim	Bayern
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Willich	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wolfenbuettel	Niedersachsen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Honduras	GSK Investigational Site	Tegucigalpa	Francisco Morazan
Panama	GSK Investigational Site	Arraijan/Vista Alegre	Panamá
Panama	GSK Investigational Site	La Chorrera
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Colombia,  Germany,  Honduras,  Panama,  Taiwan, 

References & Publications (2)

Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460. — View Citation

Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 60
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 72
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 84
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 96
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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).	At Month 60
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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).	At month 72
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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).	At Month 84
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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).	At Month 96
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 108
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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).	At Month 108
Primary	Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers	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.	At Month 120
Primary	Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.	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.	At Month 120
Secondary	Number of Subjects With 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.	From Month 48 to Month 60
Secondary	Number of Subjects With 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.	From Month 60 to Month 72
Secondary	Number of Subjects With 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.	From Month 72 to Month 84
Secondary	Number of Subjects With 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.	From Month 84 to Month 96
Secondary	Number of Subjects With 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.	From Month 96 to Month 108
Secondary	Number of Subjects With 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.	From Month 108 to Month 120

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