Clinical trial NCT00947115: Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Official title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: Cervical cancer
HPV vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 525
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. 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 (NCT00196937).

Detailed description: Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was 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 criteria: Inclusion Criteria:

* Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
* A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 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 NCT00196937 study.

Primary outcomes:
measure: Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
timeFrame: At Years 5, 6 and 7
measure: Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
timeFrame: At Years 8, 9 and 10
measure: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
timeFrame: At Years 5, 6 and 7
measure: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
timeFrame: At Years 8, 9 and 10
Secondary outcomes:
measure: Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
timeFrame: At Year 5 and Year 6
measure: Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
timeFrame: At Years 7, 8, 9 and 10
measure: Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
timeFrame: At Year 5 and Year 6
measure: Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
timeFrame: At Years 7, 8, 9 and 10
measure: Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
timeFrame: At Years 5, 6 and 7
measure: Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
timeFrame: At Years 8, 9 and 10
measure: Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
timeFrame: At Years 5, 6 and 7
measure: Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
timeFrame: At Years 8, 9 and 10
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
timeFrame: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
timeFrame: From Year 5 up to Year 6
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
timeFrame: From Year 6 up to Year 7
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
timeFrame: From Year 7 up to Year 8
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
timeFrame: From Year 8 up to Year 9
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
timeFrame: From Year 9 up to Year 10
measure: Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
timeFrame: From Year 0 up to Year 10
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.