Infections, PapillomavirusPhase 1NCT00478621
Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)
A Phase 1 study testing GSK Biologicals' HPV vaccine (GSK1674330A) and Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 3 sites in Belgium.
Trial summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- GSK Biologicals' HPV vaccine (GSK1674330A) and Cervarix TM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 3 sitesBelgium
- Study dates
- 25 May 2007to 13 Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A woman whom the investigator believes can and will comply with the requirements of the protocol.
- A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
- Written informed consent must be obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if of child bearing potential, she must have a negative pregnancy test and she 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.
- Subject who has 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 up to six months after last dose of vaccine.
- Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- 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 the study period, up to two months after the last vaccine dose.
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- 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
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination 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.
- Cancer or autoimmune disease under treatment.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology test.
- Received immunoglobulins and/or blood product within 3 months preceding enrolment or planned administration during the study period up to one month after the last dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
- Acute disease at the time of enrolment.
- Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a cervical sample cannot be collected. Enrolment will be deferred until condition is resolved according to investigators medical judgement.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Wilrijk, 2610
About this study
Official title: A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Papillomavirus
- Being tested
- GSK Biologicals' HPV vaccine (GSK1674330A), Cervarix TM
- Keywords
- HPV
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' HPV vaccine (GSK1674330A)Biological
Intramuscular administration, 5 different formulations
Cervarix TMBiological
Also called GSK Biologicals' HPV vaccine (580299)
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group B | Experimental | Not described Receives: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group C | Experimental | Not described Receives: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group D | Experimental | Not described Receives: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group E | Experimental | Not described Receives: Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group F | Active comparator | Not described Receives: Biological: Cervarix TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
Measured: Within 7 days after each vaccine dose
Secondary outcomes (8)
Occurrence of serious adverse events
Measured: Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Measured: Within 30 days after each vaccine dose
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Measured: Assessed at Month 0, one month and six months after the last dose of vaccine
Occurrence of serious adverse events during the extended safety follow-up
Measured: Up to six months after the last dose of vaccine
Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination
Measured: Throughout the study period (Month 0 up to six months after the last dose of vaccine)
HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine
Measured: One month after the second dose of vaccine, and six months after the last dose of vaccine
Seropositivity rates to other defined HPV types and GMTs before the second dose of vaccine
Measured: One month after the second dose of vaccine and at one month and six months after the last dose of vaccine
HPV-16 and -18 seropositivity rates and GMTs
Measured: One month after the last dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study start25 May 2007
- Primary completion30 Jun 2008
- Study completion13 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 540 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
- NCT00478621
- Sponsor's protocol ID
- 109836
- Status last verified
- May 2017
- First submitted
- 24 May 2007
- Last updated
- 10 May 2017
- Results posted
- No
- 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
Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.
PubMed 24674663
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.
- ClinicalTrials.gov ID
- NCT00478621
- Acronym / sponsor ID
- 109836
- Conditions
- Infections, Papillomavirus
- Keywords
- HPV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 May 2007 (actual)
- Primary completion
- 30 Jun 2008 (actual)
- Study completion
- 13 Oct 2008 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
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. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.
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
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group B | Experimental | Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group C | Experimental | Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group D | Experimental | Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group E | Experimental | Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
| Group F | Active comparator | Biological: Cervarix TM |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A woman whom the investigator believes can and will comply with the requirements of the protocol.
- A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
- Written informed consent must be obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subject must be of non-childbearing potential, or if of child bearing potential, she must have a negative pregnancy test and she 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.
Key exclusion criteria (17 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 up to six months after last dose of vaccine.
- Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
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 |
|---|---|---|
| GSK Biologicals' HPV vaccine (GSK1674330A)Intramuscular administration, 5 different formulations | Biological | Group A, Group B, Group C, Group D, Group E |
| Cervarix TMAlso: GSK Biologicals' HPV vaccine (580299)Intramuscular administration | Biological | Group F |
Primary outcome
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
Time frame: Within 7 days after each vaccine dose
8 secondary outcomes
Occurrence of serious adverse events
Time frame: Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Time frame: Within 30 days after each vaccine dose
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Time frame: Assessed at Month 0, one month and six months after the last dose of vaccine
Occurrence of serious adverse events during the extended safety follow-up
Time frame: Up to six months after the last dose of vaccine
Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination
Time frame: Throughout the study period (Month 0 up to six months after the last dose of vaccine)
HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine
Time frame: One month after the second dose of vaccine, and six months after the last dose of vaccine
Seropositivity rates to other defined HPV types and GMTs before the second dose of vaccine
Time frame: One month after the second dose of vaccine and at one month and six months after the last dose of vaccine
HPV-16 and -18 seropositivity rates and GMTs
Time frame: One month after the last dose of vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 24674663Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.
- Results for study 109836 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK Biologicals' HPV vaccine (GSK1674330A) and Cervarix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 3 sites in Belgium.
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 17 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (time frame: Within 7 days after each vaccine dose). 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 NCT00478621, 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 10 May 2017.