Infections, PapillomavirusPhase 3NCT02100618
Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
A Phase 3 study testing Blood sampling in people with Infections, Papillomavirus, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970). Read more about this study
- Who is it for?
- Ages 15 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Blood sampling
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2015
- Phase
- Phase 3
- 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 15 to 32 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Subjects who completed their primary vaccination and received either two or three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study HPV-048 PRI (110659) (NCT00541970).
- A female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study HPV-048 PRI (110659) (NCT00541970), i.e., 9-14 year old subjects should have received two doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,1,6-months schedule.
- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the HPV-16/18 study vaccine administered in the study HPV-048 PRI (110659) (NCT00541970) from the last visit of the primary study up to the current study visit or planned use during the study period.
- Administration of any HPV vaccine from the last visit of the primary study up to the current study visit or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis B, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. 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, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Cancer or autoimmune disease under treatment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the blood sampling.
About this study
Official title: Evaluation of Antibody Persistence for GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).
- Conditions
- Infections, Papillomavirus
- Being tested
- Blood sampling
- Keywords
- Adolescents, Adults, Immunogenicity, 6.5 years, Safety, Antibody persistence, Human Papillomavirus (HPV) vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Also called Cervarix™
Blood samples will be collected from all subjects at Year 6.5
| Study group | Role | What they receive |
|---|---|---|
| HPV Group 1 | Experimental | Subjects who were aged 9-14 years at study entry and received two doses of the HPV-16/18 vaccine according to a 0,6-months schedule in the study HPV-048 PRI (NCT00541970). Receives: Procedure: Blood sampling |
| HPV Group 2 | Active comparator | Subjects who were aged 15-25 years at study entry and received three doses of the HPV 16/18 vaccine according to a 0,1,6-months schedule in the study HPV-048 PRI (NCT00541970). Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immune persistence in terms of antibody titres
Measured: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970)
Secondary outcomes (2)
Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres
Measured: 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970)
Occurrence of SAEs
Measured: After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Why it stopped: Due to late study start, the possibility to enroll enough subjects dropped below the limit to provide scientifically acceptable data, hence study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02100618
- Sponsor's protocol ID
- 200255
- Other IDs
- 2014-000060-17, 2014
- Status last verified
- Jul 2015
- First submitted
- 27 Mar 2014
- Last updated
- 20 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibody Persistence for GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
- ClinicalTrials.gov ID
- NCT02100618
- Acronym / sponsor ID
- 200255
- Conditions
- Infections, Papillomavirus
- Keywords
- Adolescents, Adults, Immunogenicity, 6.5 years, Safety, Antibody persistence, Human Papillomavirus (HPV) vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to late study start, the possibility to enroll enough subjects dropped below the limit to provide scientifically acceptable data, hence study was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 1 Apr 2014 (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.
The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Group 1 | Experimental | Procedure: Blood samplingSubjects who were aged 9-14 years at study entry and received two doses of the HPV-16/18 vaccine according to a 0,6-months schedule in the study HPV-048 PRI (NCT00541970). |
| HPV Group 2 | Active comparator | Procedure: Blood samplingSubjects who were aged 15-25 years at study entry and received three doses of the HPV 16/18 vaccine according to a 0,1,6-months schedule in the study HPV-048 PRI (NCT00541970). |
Who may qualify
- Ages
- 15 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Subjects who completed their primary vaccination and received either two or three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study HPV-048 PRI (110659) (NCT00541970).
- A female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study HPV-048 PRI (110659) (NCT00541970), i.e., 9-14 year old subjects should have received two doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,1,6-months schedule.
- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (9 listed)
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the HPV-16/18 study vaccine administered in the study HPV-048 PRI (110659) (NCT00541970) from the last visit of the primary study up to the current study visit or planned use during the study period.
- Administration of any HPV vaccine from the last visit of the primary study up to the current study visit or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis B, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. Enrolment will be deferred until the subject is outside of specified window.
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 |
|---|---|---|
| Blood samplingAlso: Cervarix™Blood samples will be collected from all subjects at Year 6.5 | Procedure or surgery | HPV Group 1, HPV Group 2 |
Primary outcome
Evaluation of immune persistence in terms of antibody titres
Time frame: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970)
2 secondary outcomes
Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres
Time frame: 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970)
Occurrence of SAEs
Time frame: After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood sampling in people with Infections, Papillomavirus, run by GlaxoSmithKline.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of immune persistence in terms of antibody titres (time frame: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970)). 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 20 Jul 2015.