Last updated: 11/07/2018 02:46:37

Complementary testing to evaluate immunogenicity of Human Papillomavirus (HPV) vaccine (580299) in healthy female subjects aged >/= 26 years

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GSK study ID
109801
See study documents
Clinicaltrials.gov ID
NCT00456807
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Complementary testing to further evaluate the immunogenicity of a GSK Biologicals’ HPV vaccine (580299) in healthy female subjects aged over 26 years enrolled in study 104820.
Trial description: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of cytokine-positive CD4/CD8 cells per million in tests producing at least 2 different cytokines

Timeframe: At Month 12 and Month 18 after first vaccination

Number of B-cells per million showing a specific memory response for HPV-16 and HPV-18

Timeframe: At Month 12 and Month 18 after first vaccination

Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values

Timeframe: At Month 12 and Month 18 after first vaccination

Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies

Timeframe: At Month 12 and Month 18 after first vaccination

Titers of anti-human papilloma virus 16 (anti-HPV-16) Immunoglobulin G (IgG) antibodies

Timeframe: At Month 12 and Month 18 after first vaccination

Correlation of anti-HPV-16 and anti-HPV-18 antibodies in serum and in cervical secretion (CVS) samples

Timeframe: At Month 12 and Month 18 after first vaccination

Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Placebo
Biological/vaccine: Cervarix TM
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
2008-02-01
Time perspective:
Not applicable
Clinical publications:
Schwarz TF et al. (2010) Correlation between Levels of Human Papillomavirus (HPV)-16 and -18 Antibodies in Serum and Cervicovaginal Secretions in Girls and Women Vaccinated with HPV-16/18 AS04-Adjuvanted Vaccine. Hum Vaccin. 6(12):1054-1061.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
April 2007 to January 2008
Type
Interventional
Phase
3

Participation criteria

Sex
Female
Age
26+ years
Accepts healthy volunteers
Yes
  • A female enrolled in study 104820 and who received three doses of study vaccine/control.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Pregnancy.
  • Administration of any HPV vaccine other than that foreseen by the study protocol.
Inclusion and exclusion criteria
Inclusion criteria:
  • A female enrolled in study 104820 and who received three doses of study vaccine/control.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the subject prior to enrolment in this ancillary study.
Exclusion criteria:
  • Pregnancy.
  • Administration of any HPV vaccine other than that foreseen by the study protocol.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
  • Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Amsterdam, Netherlands, 1007 MB
Status
Study Complete
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Location
GSK Investigational Site
DELFT, Netherlands, 2625 AD
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2008-02-01
Actual study completion date
2008-02-01

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

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