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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00294047




Registration number
NCT00294047
Ethics application status
Date submitted
17/02/2006
Date registered
20/02/2006

Titles & IDs
Public title
Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
Scientific title
A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above
Secondary ID [1] 0 0
2005-002546-20
Secondary ID [2] 0 0
104820
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus 0 0
Papillomavirus Vaccines 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

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

Experimental: Cervarix Group - Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Placebo comparator: Aluminium Hydroxide Group - Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.


Treatment: Other: Cervarix
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Treatment: Other: Placebo control
Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Timepoint [1] 0 0
Up to Month 48
Primary outcome [2] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Timepoint [2] 0 0
Up to Month 48
Primary outcome [3] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Timepoint [3] 0 0
Up to Month 84
Primary outcome [4] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Timepoint [4] 0 0
Up to Month 84
Secondary outcome [1] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Timepoint [1] 0 0
Up to Month 48
Secondary outcome [2] 0 0
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Timepoint [2] 0 0
Up to Month 48
Secondary outcome [3] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Timepoint [3] 0 0
Up to Month 48
Secondary outcome [4] 0 0
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Timepoint [4] 0 0
Up to Month 48
Secondary outcome [5] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [5] 0 0
Up to Month 48
Secondary outcome [6] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [6] 0 0
Up to Month 48
Secondary outcome [7] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [7] 0 0
Up to Month 48
Secondary outcome [8] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
Timepoint [8] 0 0
Up to Month 48
Secondary outcome [9] 0 0
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Timepoint [9] 0 0
Up to Month 48
Secondary outcome [10] 0 0
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Timepoint [10] 0 0
Up to Month 48
Secondary outcome [11] 0 0
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Timepoint [11] 0 0
Up to Month 48
Secondary outcome [12] 0 0
Number of Subjects With First Colposcopy
Timepoint [12] 0 0
Up to Month 48
Secondary outcome [13] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Timepoint [13] 0 0
Up to Month 48
Secondary outcome [14] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Timepoint [14] 0 0
Up to Month 48
Secondary outcome [15] 0 0
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Timepoint [15] 0 0
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Secondary outcome [16] 0 0
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Timepoint [16] 0 0
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Secondary outcome [17] 0 0
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Timepoint [17] 0 0
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Secondary outcome [18] 0 0
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Timepoint [18] 0 0
At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Secondary outcome [19] 0 0
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
Timepoint [19] 0 0
Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Secondary outcome [20] 0 0
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
Timepoint [20] 0 0
Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Secondary outcome [21] 0 0
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Timepoint [21] 0 0
Within 7 days (Days 0-6) after vaccination
Secondary outcome [22] 0 0
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Timepoint [22] 0 0
Within 7 days (Days 0-6) after vaccination
Secondary outcome [23] 0 0
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Timepoint [23] 0 0
Within 30 days (Days 0 - 29) post-vaccination period.
Secondary outcome [24] 0 0
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Timepoint [24] 0 0
Up to Month 48 and up to Month 84
Secondary outcome [25] 0 0
Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Timepoint [25] 0 0
Up to Month 84
Secondary outcome [26] 0 0
Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
Timepoint [26] 0 0
Up to Month 84
Secondary outcome [27] 0 0
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).
Timepoint [27] 0 0
Up to Month 48
Secondary outcome [28] 0 0
Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).
Timepoint [28] 0 0
Up to Month 48
Secondary outcome [29] 0 0
Number of Subjects Reporting Medically Significant Conditions (MAEs).
Timepoint [29] 0 0
Up to Month 48
Secondary outcome [30] 0 0
Number of Subjects With Pregnancies and Their Outcomes.
Timepoint [30] 0 0
Up to Month 48
Secondary outcome [31] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
Timepoint [31] 0 0
Up to Month 48
Secondary outcome [32] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Timepoint [32] 0 0
Up to Month 84
Secondary outcome [33] 0 0
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Timepoint [33] 0 0
Up to Month 84
Secondary outcome [34] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Timepoint [34] 0 0
Up to Month 84
Secondary outcome [35] 0 0
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Timepoint [35] 0 0
Up to Month 84
Secondary outcome [36] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [36] 0 0
Up to Month 84
Secondary outcome [37] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [37] 0 0
Up to Month 84
Secondary outcome [38] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [38] 0 0
Up to Month 84
Secondary outcome [39] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
Timepoint [39] 0 0
Up to Month 84
Secondary outcome [40] 0 0
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Timepoint [40] 0 0
Up to Month 84
Secondary outcome [41] 0 0
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Timepoint [41] 0 0
Up to Month 48
Secondary outcome [42] 0 0
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Timepoint [42] 0 0
Up to Month 84
Secondary outcome [43] 0 0
Number of Subjects With First Colposcopy
Timepoint [43] 0 0
Up to Month 84
Secondary outcome [44] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Timepoint [44] 0 0
Up to Month 84
Secondary outcome [45] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Timepoint [45] 0 0
Up to Month 84

Eligibility
Key inclusion criteria
Inclusion criteria:

* A woman who the investigator believes that she can and will comply with the requirements of the protocol.
* A women of at least 26 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subject must have intact cervix.
* Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential.
* Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Minimum age
26 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
* A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8).
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84).
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 - 29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous administration of components of the investigational vaccine
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.
* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* History of chronic condition(s) requiring treatment.
* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
* Acute disease at the time of enrolment.
* Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.

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 administering the treatment/s
The people assessing the outcomes
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
16/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2014
Sample size
Target
Accrual to date
Final
5752
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [2] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Mexico
State/province [27] 0 0
Morelos
Country [28] 0 0
Mexico
State/province [28] 0 0
Jojutla / Morelos
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Delft
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Peru
State/province [32] 0 0
Lima
Country [33] 0 0
Philippines
State/province [33] 0 0
Laguna
Country [34] 0 0
Philippines
State/province [34] 0 0
San Pablo City
Country [35] 0 0
Philippines
State/province [35] 0 0
Taft Avenue, Manila
Country [36] 0 0
Portugal
State/province [36] 0 0
Almada
Country [37] 0 0
Portugal
State/province [37] 0 0
Coimbra
Country [38] 0 0
Portugal
State/province [38] 0 0
Lisboa
Country [39] 0 0
Portugal
State/province [39] 0 0
Porto
Country [40] 0 0
Portugal
State/province [40] 0 0
Setúbal
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Ekaterinburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Sankt-Petersburg
Country [44] 0 0
Singapore
State/province [44] 0 0
Singapore
Country [45] 0 0
Thailand
State/province [45] 0 0
Bangkok
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Middlesex
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Aberdeen
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Cardiff
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Gateshead
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester

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

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?
IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=1517


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/NCT00294047