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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00456807
Registration number
NCT00456807
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007
Date last updated
16/12/2016
Titles & IDs
Public title
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years
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Scientific 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.
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Secondary ID [1]
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109801
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - Cervarix TM
Experimental: Cervarix Group - Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Placebo Comparator: Placebo Group - Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Other interventions: Placebo
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Other interventions: Cervarix TM
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
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Assessment method [1]
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The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
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Timepoint [1]
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At Month 12 and Month 18 after first vaccination
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Primary outcome [2]
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Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
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Assessment method [2]
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The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.
An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
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Timepoint [2]
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At Month 12 and Month 18 after first vaccination
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Primary outcome [3]
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Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
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Assessment method [3]
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Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
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Timepoint [3]
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At Month 12 and Month 18 after first vaccination
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Primary outcome [4]
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Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
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Assessment method [4]
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Titers are presented as Geometric Mean Titers (GMTs).
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Timepoint [4]
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At Month 12 and Month 18 after first vaccination
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Primary outcome [5]
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Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
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Assessment method [5]
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Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
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Timepoint [5]
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At Month 12 and Month 18 after first vaccination
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Primary outcome [6]
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Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
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Assessment method [6]
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Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.
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Timepoint [6]
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At Month 12 and Month 18 after first vaccination
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Eligibility
Key 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.
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Minimum age
26
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2008
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Netherlands
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State/province [1]
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Amsterdam
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Country [2]
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Netherlands
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State/province [2]
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Delft
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00456807
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00456807
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