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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00122681
Ethics application status
Date submitted
20/07/2005
Date registered
20/07/2005
Date last updated
2/07/2018

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Cervarix™
Other interventions - 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.


Other interventions: Cervarix™
Intramuscular injection, 3 doses

Other interventions: Havrix™-based investigational formulation
Intramuscular injection, 3 doses

Intervention code [1] 0 0
Other interventions
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) - CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in:
DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial 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) - CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial 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 - CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial 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
Secondary outcome [2] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms - Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Data are presented across the 3 doses.
Timepoint [2] 0 0
Within 7 days after any vaccination
Secondary outcome [3] 0 0
Number of Subjects Reporting Unsolicited Adverse Events - Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Timepoint [3] 0 0
Within 30 days after any vaccination
Secondary outcome [4] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs) - SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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) - NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Timepoint [5] 0 0
Throughout the entire study (Month 0 to 48)
Secondary outcome [6] 0 0
Number of Subjects Reporting Medically Significant Conditions - Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
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 - Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.
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 - Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
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 - Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
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 - Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
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 - Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
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 - CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
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 - Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
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 - Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).
Detection was done in subjects:
DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
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 - Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
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 - Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
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 - CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.
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 - CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.
Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.
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 - Cut-off values assessed for seropositivity 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.
Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)
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 - Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).
GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)].
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) - HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.
HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL.
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) - Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).
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) - Seropositivity was defined as subjects with a titer equal to or greater than 40.
Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination.
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) - Titers were expressed as GMTs.
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 - GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
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. - Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.
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 - GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
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 - Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
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 - GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
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. - Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
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 - GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
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 - Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Waterloo, Liverpool

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

Ethics approval
Ethics application status

Summary
Brief summary
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
genitals in men and women. Several types of HPV infection are transmitted by sexual activity
and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
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. If a woman is not infected by
HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated
cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in
young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study
subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine)
administered intramuscularly according to a 0-1-6 month schedule.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Trial website
https://clinicaltrials.gov/show/NCT00122681
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

No data has been provided for results reporting
Summary results
Other publications