Infections, PapillomavirusPhase 3NCT00552279
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
A Phase 3 study testing Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 16 sites in 3 countries.
Trial summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to… Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cervarix TM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 12 Nov 2007to 20 Jul 2009
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
- A female between and including 15 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and/or clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- Subject who had no more than 6 lifetime sexual partners prior to enrolment.
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.
- 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. 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 patient is outside of specified window.
- Concurrently participating in another clinical study, at any time during the study period, 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.
- previous administration of components of the investigational vaccine
Show all 15Show fewer
- 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.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Pregnant or breastfeeding female.
- Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Italy7 sites
GSK Investigational Site
Brescia, Lombardy, 25123
GSK Investigational Site
Cagliari, Sardinia, 09127
GSK Investigational Site
Lodi, Lombardy, 26900
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Palermo, Sicily, 90127
GSK Investigational Site
Ragusa, Sicily, 97100
GSK Investigational Site
Sassari, Sardinia, 07100
Romania6 sites
GSK Investigational Site
Bucharest, 010507
GSK Investigational Site
Bucharest, 077190
GSK Investigational Site
Bucharest, 22102
GSK Investigational Site
Cluj-Napoca, 400217
GSK Investigational Site
Sibiu, 550245
GSK Investigational Site
Sibiu
Slovakia3 sites
GSK Investigational Site
Dolný Kubín, 026 01
GSK Investigational Site
Nová Dubnica, 018 51
GSK Investigational Site
Trenčín, 911 01
About this study
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix TM
- Keywords
- HPV, cervical cancer, papillomavirus, Human papillomavirus (HPV) vaccine
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervarix TMBiological
Also called HPV vaccine (GSK580299)
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Cervarix TMBiological
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix-12 Group | Experimental | Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule Receives: Biological: Cervarix TM |
| Cervarix-6 Group | Active comparator | Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule. Receives: Biological: Cervarix TM |
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 after the third vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as geometric mean titer (GMT).
Measured: One month after the third vaccine dose
Secondary outcomes (8)
Number of Subjects Seroconverted for Anti-HPV-16 and 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 after the second vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titer given as GMT.
Measured: One month after the second vaccine dose
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
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
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 30-day (Days 0-29) period following each vaccination
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6.
NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: During the entire study period (up to Month 18 or up to Month 12)
Number of Subjects With Pregnancies and Their Outcomes
Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6
Number of pregnancies and pregnancy outcomes.
Measured: During the entire study period (up to Month 18 or Month 12)
Number of Subjects Completing the 3-dose Vaccination Schedule
Measured: After the third vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study start12 Nov 2007
- Primary completion26 Feb 2009
- Study completion20 Jul 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 805 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
- NCT00552279
- Sponsor's protocol ID
- 109179
- Status last verified
- Apr 2017
- First submitted
- 30 Oct 2007
- Last updated
- 25 Jun 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.
Publications
Esposito S, Birlutiu V, Jarcuska P, Perino A, Man SC, Vladareanu R, Meric D, Dobbelaere K, Thomas F, Descamps D. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 2011 Mar;30(3):e49-55. doi: 10.1097/INF.0b013e318206c26e.
PubMed 21273939
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years
- ClinicalTrials.gov ID
- NCT00552279
- Acronym / sponsor ID
- 109179
- Conditions
- Infections, Papillomavirus
- Keywords
- HPV, cervical cancer, papillomavirus, Human papillomavirus (HPV) vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2007
- Primary completion
- 26 Feb 2009 (actual)
- Study completion
- 20 Jul 2009 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 5 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervarix-12 Group | Experimental | Biological: Cervarix TMWomen received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule |
| Cervarix-6 Group | Active comparator | Biological: Cervarix TMWomen received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
- A female between and including 15 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and/or clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Key exclusion criteria (15 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.
- 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. 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 patient is outside of specified window.
- Concurrently participating in another clinical study, at any time during the study period, 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.
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 TMAlso: HPV vaccine (GSK580299)Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule. | Biological | Cervarix-12 Group |
| Cervarix TMIntramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | Biological | Cervarix-6 Group |
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 after the third vaccine dose
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.
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Time frame: One month after the third vaccine dose
Titer given as geometric mean titer (GMT).
8 secondary outcomes
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Time frame: One month after the second vaccine dose
Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Time frame: One month after the second vaccine dose
Number of Subjects Reporting Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period following each vaccination
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), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Time frame: During the entire study period (up to Month 18 or up to Month 12)
Number of Subjects With Pregnancies and Their Outcomes
Time frame: During the entire study period (up to Month 18 or Month 12)
Number of Subjects Completing the 3-dose Vaccination Schedule
Time frame: After the third vaccine dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21273939Esposito S, Birlutiu V, Jarcuska P, Perino A, Man SC, Vladareanu R, Meric D, Dobbelaere K, Thomas F, Descamps D. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 2011 Mar;30(3):e49-55. doi: 10.1097/INF.0b013e318206c26e.
- 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
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 16 sites in 3 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 15 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy, Romania, Slovakia. 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 5 Mar 2010). 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 after the third vaccine dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552279, which also lists 1 linked publication.
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 25 Jun 2018.