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

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 GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT 00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT 00196937).

Condition	Intervention	Phase
Human Papillomavirus Infection	Procedure: Blood sampling Procedure: Cervico-vaginal secretion (CVS) samples	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Human papillomavirus vaccine, L1 type 16, 18

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum [ Time Frame: At Year 5 and 6 ] [ Designated as safety issue: No ]
Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum [ Time Frame: At Years 7, 8, 9, 10 ] [ Designated as safety issue: No ]
Number of Seroconverted Subjects. [ Time Frame: At Year 5 and Year 6 ] [ Designated as safety issue: No ]
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
Number of Seroconverted Subjects. [ Time Frame: At Years 7, 8, 9, 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total Immunoglobulin G (IgG) Antibody Titers in Serum [ Time Frame: At Year 5 and Year 6 ] [ Designated as safety issue: No ]
IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
Total Immunoglobulin G (IgG) Antibody Titers in Serum [ Time Frame: At Years 7, 8, 9, 10 ] [ Designated as safety issue: No ]
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) [ Time Frame: At Year 5 and Year 6 ] [ Designated as safety issue: No ]
Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) [ Time Frame: At Years 7, 8, 9, 10 ] [ Designated as safety issue: No ]
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS [ Time Frame: At Year 5 and Year 6 ] [ Designated as safety issue: No ]
Titers were given as GMTs expressed in microgram per milliliter (µg/mL).
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS [ Time Frame: At Years 7, 8, 9, 10 ] [ Designated as safety issue: No ]
Number of Subjects With Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5) ] [ 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 Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit ] [ 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 Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 72 (Year 6) visit to Month 84 (Year 7) visit ] [ 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 Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: Until Year 10 ] [ Designated as safety issue: No ]
Number of Subjects With Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Year 0 up to Year 7 ] [ 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.

Enrollment:	666
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2015
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cervarix 15-25 years group Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)	Procedure: Blood sampling Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10 Procedure: Cervico-vaginal secretion (CVS) samples CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.
Experimental: Cervarix 26-45 years group Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)	Procedure: Blood sampling Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10 Procedure: Cervico-vaginal secretion (CVS) samples CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.
Experimental: Cervarix 46-55 years group Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)	Procedure: Blood sampling Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10 Procedure: Cervico-vaginal secretion (CVS) samples CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.

Detailed Description:

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). 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:	20 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A female who enrolled in NCT00332475 and received three doses of GSK 580299 vaccine.
Written informed consent obtained from the subject.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
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 (pharmaceutical product or device).
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00332475 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947115

Locations

Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Berlin, Germany, 12200
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Poznan, Poland, 60-535
GSK Investigational Site
Poznan, Poland, 6-709

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00947115 History of Changes
Other Study ID Numbers:	112772
Study First Received:	July 16, 2009
Results First Received:	February 10, 2011
Last Updated:	February 21, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Cervical cancer
HPV vaccine

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 May 19, 2013