Infections, PapillomavirusPhase 3NCT00492544
Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
A Phase 3 study testing Cervarix™ (HPV-16/18 L1 VLP AS04) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial summary
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. Read more about this study
- Who is it for?
- Ages 10 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cervarix™ (HPV-16/18 L1 VLP AS04)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Jul 2007to 28 Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator/co-investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A Japanese female between, and including, 10 and 15 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s) or legally acceptable representative(s) of the subject. In addition, a written informed assent must be obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- All subjects must have a negative urine pregnancy test.
- Subjects must be of non-childbearing potential, or, if of childbearing potential, they must be abstinent or have used adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Non-abstinent pre-menarche subjects, as well as subjects who reach menarche during study, must follow the same precautions.
Who cannot join
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during study.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Administration of 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.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 7), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 7).
- Previous administration of components of the investigational vaccine .
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- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or breastfeeding subject.
- Subject planning to become pregnant or planning to discontinue contraceptive precautions.
- Oral temperature ≥ 37.5°C/Axillary temperature ≥ 37.5°C.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Japan4 sites
GSK Investigational Site
Saitama, 360-0812
GSK Investigational Site
Saitama, 360-0846
GSK Investigational Site
Tokyo, 136-0073
GSK Investigational Site
Tokyo, 154-0024
Location not given1 site
GSK Investigational Site
About this study
Official title: Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix™ (HPV-16/18 L1 VLP AS04)
- Keywords
- Human Papillomavirus (HPV) vaccine, safety, cervical cancer, immunogenicity, vaccine, viral infections, pre-adolescent and adolescent females
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervarix™ (HPV-16/18 L1 VLP AS04)Biological
Also called GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix | Experimental | Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule. Receives: Biological: Cervarix™ (HPV-16/18 L1 VLP AS04) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 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.
Measured: One month post Dose 3 (Month 7)
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Measured: Before vaccination (PRE) and one month post Dose 3 (Month 7)
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Measured: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Measured: During the 7-day (Days 0-6) period following each vaccination
Secondary outcomes (5)
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Measured: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.
Measured: From Day 0 up to Month 7
Outcome of All Pregnancies
According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.
Measured: Up to Month 7
Number of Subjects Reporting Serious Adverse Events (SAEs)
Serious adverse events 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.
Measured: From Day 0 up to Month 7
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Abnormalities include values outside (above or below) the normal ranges.
Normal ranges:
alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL
Measured: At Day 0 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study start2 Jul 2007
- Primary completion28 Mar 2008
- Study completion28 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492544
- Sponsor's protocol ID
- 110168
- Status last verified
- Aug 2018
- First submitted
- 26 Jun 2007
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.
- ClinicalTrials.gov ID
- NCT00492544
- Acronym / sponsor ID
- 110168
- Conditions
- Infections, Papillomavirus
- Keywords
- Human Papillomavirus (HPV) vaccine, safety, cervical cancer, immunogenicity, vaccine, viral infections, pre-adolescent and adolescent females
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2007 (actual)
- Primary completion
- 28 Mar 2008 (actual)
- Study completion
- 28 Mar 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 21 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervarix | Experimental | Biological: Cervarix™ (HPV-16/18 L1 VLP AS04)Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator/co-investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A Japanese female between, and including, 10 and 15 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s) or legally acceptable representative(s) of the subject. In addition, a written informed assent must be obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- All subjects must have a negative urine pregnancy test.
Key exclusion criteria (16 listed)
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during study.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Administration of 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.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 7), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 7).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervarix™ (HPV-16/18 L1 VLP AS04)Also: GSK Biologicals' HPV-16/18 VLP/AS04 vaccineThree doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. | Biological | Cervarix |
Primary outcome
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Time frame: One month post Dose 3 (Month 7)
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Time frame: Before vaccination (PRE) and one month post Dose 3 (Month 7)
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Number of Subjects Reporting Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) period following each vaccination
Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period following each vaccination
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
5 secondary outcomes
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Time frame: From Day 0 up to Month 7
Outcome of All Pregnancies
Time frame: Up to Month 7
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From Day 0 up to Month 7
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Time frame: At Day 0 and Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervarix™ (HPV-16/18 L1 VLP AS04) in people with Infections, Papillomavirus, run by GlaxoSmithKline at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (time frame: One month post Dose 3 (Month 7)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.