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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00122681




Registration number
NCT00122681
Ethics application status
Date submitted
20/07/2005
Date registered
22/07/2005

Titles & IDs
Public title
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Scientific title
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Secondary ID [1] 0 0
580299/008
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
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 - Havrix™-based investigational formulation

Experimental: Cervarix Group - Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.

Active comparator: Havrix Group - Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.


Treatment: Other: Cervarix™
Intramuscular injection, 3 doses

Treatment: Other: Havrix™-based investigational formulation
Intramuscular injection, 3 doses
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)
Timepoint [1] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3
Primary outcome [2] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)
Timepoint [2] 0 0
at Month 48
Secondary outcome [1] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [1] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [2] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms
Timepoint [2] 0 0
Within 7 days after any vaccination
Secondary outcome [3] 0 0
Number of Subjects Reporting Unsolicited Adverse Events
Timepoint [3] 0 0
Within 30 days after any vaccination
Secondary outcome [4] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Throughout the entire study period (Month 0 to Month 48)
Secondary outcome [5] 0 0
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)
Timepoint [5] 0 0
Throughout the entire study (Month 0 to 48)
Secondary outcome [6] 0 0
Number of Subjects Reporting Medically Significant Conditions
Timepoint [6] 0 0
Throughout entire study period (Month 0 to Month 48)
Secondary outcome [7] 0 0
Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus
Timepoint [7] 0 0
Throughout the entire study period (Month 0 to Month 48)
Secondary outcome [8] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18
Timepoint [8] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [9] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18
Timepoint [9] 0 0
at Month 48
Secondary outcome [10] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types
Timepoint [10] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [11] 0 0
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types
Timepoint [11] 0 0
at Month 48
Secondary outcome [12] 0 0
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [12] 0 0
at Month 48
Secondary outcome [13] 0 0
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18
Timepoint [13] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [14] 0 0
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18
Timepoint [14] 0 0
at Month 48
Secondary outcome [15] 0 0
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [15] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [16] 0 0
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [16] 0 0
at Month 48
Secondary outcome [17] 0 0
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [17] 0 0
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Secondary outcome [18] 0 0
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timepoint [18] 0 0
at Month 48
Secondary outcome [19] 0 0
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus
Timepoint [19] 0 0
At Months 6, 7, 12, 24, 36 & 48
Secondary outcome [20] 0 0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset
Timepoint [20] 0 0
At Months 6, 7, 12, 24, 36 and 48
Secondary outcome [21] 0 0
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)
Timepoint [21] 0 0
Month 0, 7, 12 and 24
Secondary outcome [22] 0 0
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)
Timepoint [22] 0 0
Month 0, 7, 12, 24
Secondary outcome [23] 0 0
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)
Timepoint [23] 0 0
At Month 0, 7, 12, 24, 36 and 48
Secondary outcome [24] 0 0
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)
Timepoint [24] 0 0
At month 0, 7, 12, 24, 36 and 48
Secondary outcome [25] 0 0
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection
Timepoint [25] 0 0
At Month 7
Secondary outcome [26] 0 0
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.
Timepoint [26] 0 0
At Month 7
Secondary outcome [27] 0 0
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection
Timepoint [27] 0 0
At Month 7
Secondary outcome [28] 0 0
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection
Timepoint [28] 0 0
At Month 7
Secondary outcome [29] 0 0
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection
Timepoint [29] 0 0
At Month 7
Secondary outcome [30] 0 0
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.
Timepoint [30] 0 0
At Month 7
Secondary outcome [31] 0 0
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection
Timepoint [31] 0 0
At Month 7
Secondary outcome [32] 0 0
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection
Timepoint [32] 0 0
At Month 7

Eligibility
Key inclusion criteria
* A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
* A woman between, and including, 15 and 25 years of age at the time of the first vaccination.
* Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent).
* Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subject must have a negative urine pregnancy test.
* Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
* Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.
* Subject must have intact cervix.
Minimum age
15 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8).
* Previous administration of components of the investigational vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* 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) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous vaccination against human papillomavirus (HPV).
* History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease.
* History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
* 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 vaccines.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* History of chronic condition(s) requiring treatment.
* Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment 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. Enrollment will be deferred until condition is resolved according to investigator's 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 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
6/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/11/2009
Sample size
Target
Accrual to date
Final
18729
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [3] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [4] 0 0
GSK Investigational Site - Carlton, Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [6] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
4001 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Carlton, Melbourne
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Edegem
Country [27] 0 0
Belgium
State/province [27] 0 0
Leuven
Country [28] 0 0
Brazil
State/province [28] 0 0
Paraná
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Newfoundland and Labrador
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Finland
State/province [38] 0 0
Espoo
Country [39] 0 0
Finland
State/province [39] 0 0
Helsinki
Country [40] 0 0
Finland
State/province [40] 0 0
Jarvenpaa
Country [41] 0 0
Finland
State/province [41] 0 0
Jyvaskyla
Country [42] 0 0
Finland
State/province [42] 0 0
Kerava
Country [43] 0 0
Finland
State/province [43] 0 0
Kotka
Country [44] 0 0
Finland
State/province [44] 0 0
Kouvola
Country [45] 0 0
Finland
State/province [45] 0 0
Kuopio
Country [46] 0 0
Finland
State/province [46] 0 0
Lahti
Country [47] 0 0
Finland
State/province [47] 0 0
Lappeenranta
Country [48] 0 0
Finland
State/province [48] 0 0
Mikkeli
Country [49] 0 0
Finland
State/province [49] 0 0
Oulu
Country [50] 0 0
Finland
State/province [50] 0 0
Pori
Country [51] 0 0
Finland
State/province [51] 0 0
Rauma
Country [52] 0 0
Finland
State/province [52] 0 0
Seinajoki
Country [53] 0 0
Finland
State/province [53] 0 0
Tampere
Country [54] 0 0
Finland
State/province [54] 0 0
Turku
Country [55] 0 0
Finland
State/province [55] 0 0
Vaasa
Country [56] 0 0
Germany
State/province [56] 0 0
Baden-Wuerttemberg
Country [57] 0 0
Germany
State/province [57] 0 0
Bayern
Country [58] 0 0
Germany
State/province [58] 0 0
Hessen
Country [59] 0 0
Germany
State/province [59] 0 0
Niedersachsen
Country [60] 0 0
Germany
State/province [60] 0 0
Rheinland-Pfalz
Country [61] 0 0
Germany
State/province [61] 0 0
Sachsen
Country [62] 0 0
Germany
State/province [62] 0 0
Thueringen
Country [63] 0 0
Germany
State/province [63] 0 0
Berlin
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Italy
State/province [65] 0 0
Emilia-Romagna
Country [66] 0 0
Italy
State/province [66] 0 0
Lombardia
Country [67] 0 0
Mexico
State/province [67] 0 0
Morelos
Country [68] 0 0
Philippines
State/province [68] 0 0
Cavite
Country [69] 0 0
Philippines
State/province [69] 0 0
Laguna
Country [70] 0 0
Philippines
State/province [70] 0 0
Las Pinas City
Country [71] 0 0
Philippines
State/province [71] 0 0
Los Banos, Laguna
Country [72] 0 0
Philippines
State/province [72] 0 0
Makati City
Country [73] 0 0
Philippines
State/province [73] 0 0
Manila
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
L'Hospitalet de Llobregat
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Marid
Country [78] 0 0
Spain
State/province [78] 0 0
Móstoles
Country [79] 0 0
Taiwan
State/province [79] 0 0
Taipei
Country [80] 0 0
Thailand
State/province [80] 0 0
Bangkok
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Aberdeen
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Manchester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Waterloo, Liverpool

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?
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/NCT00122681