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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00456807




Registration number
NCT00456807
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007

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
Vaginal Hysterectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo
Treatment: Other - 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).


Treatment: Other: Placebo
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Treatment: Other: Cervarix TM
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Intervention code [1] 0 0
Treatment: Other
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
Primary outcome [7] 0 0
Pain score
Timepoint [7] 0 0
Primary outcome [8] 0 0
Time to discharge
Timepoint [8] 0 0
Primary outcome [9] 0 0
Blood loss
Timepoint [9] 0 0
Secondary outcome [1] 0 0
Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Safety data
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Cost
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Complications
Timepoint [4] 0 0

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)
NSW,VIC
Recruitment hospital [1] 0 0
Sanofi-Aventis - Cove
Recruitment hospital [2] 0 0
Moorabin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment postcode(s) [2] 0 0
8148 - Melbourne
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
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Johnson & Johnson
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00456807