InfluenzaPhase 3NCT01160237
Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM
A Phase 3 study testing PandemrixTM and FluarixTM/ Influsplit SSW® 2010/2011 in people with Influenza, run by GlaxoSmithKline at 5 sites in Germany.
Trial summary
The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- PandemrixTM and FluarixTM/ Influsplit SSW® 2010/2011
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesGermany
- Study dates
- Aug 2010to Feb 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug and alcohol abuse.
- Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to be enrolled in the Groups A or B OR subjects who have not been previously vaccinated with a vaccine against the pandemic H1N1 strain at all, to be enrolled in group C.
- A male or female 18 years and above at the time of enrolment.
- Written informed consent obtained from the subject.
- Healthy subjects or free of acute aggravation of the health status as established by physical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Administration of any influenza vaccine within 6 month prior to vaccination in this study.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature ≥ 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within the past 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
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- Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period..
- Any administration of a long-acting immune-modifying drug (within 3 months before study start, or a planned administration during the study period.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- Administration of any vaccines within 30 days before vaccination.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions from study inclusion up to 2 months after completion of the vaccination series.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074
GSK Investigational Site
Würzburg, Bavaria, 97070
About this study
Official title: Immunogenicity and Safety of Fluarix™/ Influsplit SSW® 2010/2011 or Pandemrix™
The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control.
This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.
- Conditions
- Influenza
- Being tested
- PandemrixTM, FluarixTM/ Influsplit SSW® 2010/2011
- Keywords
- H1N1, Pandemrix, Fluarix, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PandemrixTMBiological
One dose intramuscular injection
FluarixTM/ Influsplit SSW® 2010/2011Biological
One dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain Receives: Biological: PandemrixTM |
| Group B | Experimental | Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain Receives: Biological: FluarixTM/ Influsplit SSW® 2010/2011 |
| Group C | Active comparator | Subjects not previously vaccinated with a vaccine against the pandemic H1N1 strain Receives: Biological: FluarixTM/ Influsplit SSW® 2010/2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
Measured: 21 days after vaccination
Secondary outcomes (5)
Solicited Local and General Symptoms
Measured: During 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Measured: During 31 days (Day 0 - Day 30) after vaccination
Number of Subjects Reporting Serious Adverse Events
Measured: During the whole study period (Day 0 - Day 182)
Potential Immune Mediated Diseases
Measured: During the whole study period (Day 0 - Day 182)
Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years
Measured: At Days 0, 7 and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.
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 InfluenzaStudies 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
- 7 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
- NCT01160237
- Sponsor's protocol ID
- 114454
- Status last verified
- Sep 2016
- First submitted
- 8 Jul 2010
- Last updated
- 20 Oct 2016
- 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 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Fluarix™/ Influsplit SSW® 2010/2011 or Pandemrix™
- ClinicalTrials.gov ID
- NCT01160237
- Acronym / sponsor ID
- 114454
- Conditions
- Influenza
- Keywords
- H1N1, Pandemrix, Fluarix, Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Posted 23 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control.
This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: PandemrixTMSubjects previously vaccinated with a vaccine against the pandemic H1N1 strain |
| Group B | Experimental | Biological: FluarixTM/ Influsplit SSW® 2010/2011Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain |
| Group C | Active comparator | Biological: FluarixTM/ Influsplit SSW® 2010/2011Subjects not previously vaccinated with a vaccine against the pandemic H1N1 strain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug and alcohol abuse.
- Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to be enrolled in the Groups A or B OR subjects who have not been previously vaccinated with a vaccine against the pandemic H1N1 strain at all, to be enrolled in group C.
- A male or female 18 years and above at the time of enrolment.
- Written informed consent obtained from the subject.
- Healthy subjects or free of acute aggravation of the health status as established by physical examination before entering into the study.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Administration of any influenza vaccine within 6 month prior to vaccination in this study.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature ≥ 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within the past 3 years.
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 |
|---|---|---|
| PandemrixTMOne dose intramuscular injection | Biological | Group A |
| FluarixTM/ Influsplit SSW® 2010/2011One dose intramuscular injection | Biological | Group B, Group C |
Primary outcome
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
Time frame: 21 days after vaccination
5 secondary outcomes
Solicited Local and General Symptoms
Time frame: During 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During 31 days (Day 0 - Day 30) after vaccination
Number of Subjects Reporting Serious Adverse Events
Time frame: During the whole study period (Day 0 - Day 182)
Potential Immune Mediated Diseases
Time frame: During the whole study period (Day 0 - Day 182)
Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years
Time frame: At Days 0, 7 and 182
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PandemrixTM and FluarixTM/ Influsplit SSW® 2010/2011 in people with Influenza, run by GlaxoSmithKline at 5 sites in Germany.
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 7 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: stopped early, as of the sponsor's last update on 20 Oct 2016. 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 Germany. 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 23 Mar 2012). 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?
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years (time frame: 21 days after vaccination). 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 Oct 2016.