Last updated: 10/02/2020 14:40:08
Evaluation of long-term immunogenicity and safety of a Human Papillomavirus (HPV) vaccine in healthy female subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Follow-up study to evaluate the long-term immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV (580299) vaccine in healthy female subjects
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Anti-Human Papillomavirus (Anti-HPV)-16/18 antibody titers in serum at years 5, 6 and 7
Timeframe: At Years 5, 6 and 7
Anti-HPV-16/18 antibody titers in serum at years 8, 9 and 10
Timeframe: At Years 8, 9 and 10
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
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:
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
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
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
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
Evaluation of immune responses to components of the vaccine in serum from efficacy studies [HPV-001/ HPV-007/HPV-023 (NCT00518336)]: Anti-HPV-16 and anti-HPV-18 antibody titers by ELISA
Timeframe: At Years 5, 6, 7, 8, 9 and 10
Evaluation of immune responses to components of the vaccine in serum elicited after natural infection [HPV 008 (NCT00122681) study]: Anti-HPV-16 and anti-HPV-18 antibody titers by ELISA
Timeframe: At Years 5, 6, 7, 8, 9 and 10
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
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
Total IgG antibody titers in serum at Years 5, 6 and 7 based on the TVC
Timeframe: At Years 5, 6 and 7
Total IgG antibody titers in serum at Years 8, 9 and 10 based on the TVC
Timeframe: At Years 8, 9 and 10
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
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
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
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
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
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
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
Interventions:
Procedure/surgery: Blood sampling
Procedure/surgery: Cervico-vaginal secretion (CVS) samples
Enrollment:
525
Observational study model:
Not applicable
Primary completion date:
2015-03-02
Time perspective:
Not applicable
Clinical publications:
Schwarz T et al. (2015) 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.122(1):107-118.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
September 2009 to February 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
20 - 60 Years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
Exclusion criteria:
- 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.
Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-03-02
Actual study completion date
2015-03-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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