Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Secondary ID [1] 0 0
109801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
Timepoint [1] 0 0
At Month 12 and Month 18 after first vaccination
Primary outcome [2] 0 0
Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
Timepoint [2] 0 0
At Month 12 and Month 18 after first vaccination
Primary outcome [3] 0 0
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
Timepoint [3] 0 0
At Month 12 and Month 18 after first vaccination
Primary outcome [4] 0 0
Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
Timepoint [4] 0 0
At Month 12 and Month 18 after first vaccination
Primary outcome [5] 0 0
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
Timepoint [5] 0 0
At Month 12 and Month 18 after first vaccination
Primary outcome [6] 0 0
Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
Timepoint [6] 0 0
At Month 12 and Month 18 after first vaccination

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.
Minimum age
26 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Amsterdam
Country [2] 0 0
Netherlands
State/province [2] 0 0
Delft

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00456807
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries