InfluenzaPhase 2NCT00968890
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
A Phase 2 study testing Pandemrix (Influenza vaccine GSK2340272A) and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 2 sites in Sweden.
Trial summary
The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older. Read more about this study
- Who is it for?
- Ages 61 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Pandemrix (Influenza vaccine GSK2340272A) and Fluarix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 2 sitesSweden
- Study dates
- 12 Sep 2009to 23 Sep 2010
- Phase
- Phase 2
- 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 61 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects 61 years of age or older at the time of the first vaccination
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination.
- Access to a consistent means of telephone contact.
Who cannot join
- Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of any vaccine within 30 days before first vaccination.
- Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- 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.
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- Presence of an oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
- Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire 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 anti-platelet 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.
- Serious chronic disease as determined by medical history and physical examination.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
- Any known or suspected allergy to any constituent of influenza vaccines.
- History of chronic alcohol consumption and/or drug abuse.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Örebro, SE-703 62
About this study
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older
The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.
Read the detailed description
The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.
The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.
- Conditions
- Influenza
- Being tested
- Pandemrix (Influenza vaccine GSK2340272A), Fluarix™, Placebo
- Keywords
- GSK Bio's influenza vaccine GSK2340272A, Influenza infection
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemrix (Influenza vaccine GSK2340272A)Biological
Intramuscular injection, 2 doses
Fluarix™Biological
Also called 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Intramuscular injection, 1 dose
PlaceboBiological
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Experimental | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. Receives: Biological: Pandemrix (Influenza vaccine GSK2340272A); Biological: Fluarix™; Biological: Placebo |
| Pandemrix+Placebo and Pandemrix+Fluarix | Experimental | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. Receives: Biological: Pandemrix (Influenza vaccine GSK2340272A); Biological: Fluarix™; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Secondary outcomes (9)
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Titers are expressed as GMTs.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: Days 0, 21, 42, 182, 364
Number of Seroconverted Subjects
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Seroprotected Subjects
A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Geometric Mean Fold Rise (GMFR)
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Subjects With Titers Equal to or Above Titer 1:10
The cut-off 1:10 was considered as seropositivity.
The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Measured: Days 0, 21, 42, 182, 364
Number of Subjects With Solicited Local and General Symptoms
Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).
Measured: Within 7 days (Day 0-Day 6) after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Measured: From Day 0 to Day 83
Number of Subjects With Adverse Events of Specific Interest
Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
Measured: From Day 0 to Day 364
Number of Subjects With Serious Adverse Events (SAEs)
SAEs 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 to Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study start12 Sep 2009
- Primary completion23 Sep 2010
- Study completion23 Sep 2010
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 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 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
- NCT00968890
- Sponsor's protocol ID
- 113525
- Status last verified
- Sep 2016
- First submitted
- 27 Aug 2009
- Last updated
- 20 Aug 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
Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9.
PubMed 22885014
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older
- ClinicalTrials.gov ID
- NCT00968890
- Acronym / sponsor ID
- 113525
- Conditions
- Influenza
- Keywords
- GSK Bio's influenza vaccine GSK2340272A, Influenza infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2009
- Primary completion
- 23 Sep 2010 (actual)
- Study completion
- 23 Sep 2010 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Posted 16 Mar 2011
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 the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.
Detailed description
The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.
The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Experimental | Biological: Pandemrix (Influenza vaccine GSK2340272A), Biological: Fluarix™, Biological: PlaceboSubjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Pandemrix+Placebo and Pandemrix+Fluarix | Experimental | Biological: Pandemrix (Influenza vaccine GSK2340272A), Biological: Fluarix™, Biological: PlaceboSubjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects 61 years of age or older at the time of the first vaccination
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination.
- Access to a consistent means of telephone contact.
Key exclusion criteria (19 listed)
- Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of any vaccine within 30 days before first vaccination.
- Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
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 |
|---|---|---|
| Pandemrix (Influenza vaccine GSK2340272A)Intramuscular injection, 2 doses | Biological | Pandemrix+Fluarix and Pandemrix+Placebo, Pandemrix+Placebo and Pandemrix+Fluarix |
| Fluarix™Also: 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccineIntramuscular injection, 1 dose | Biological | Pandemrix+Fluarix and Pandemrix+Placebo, Pandemrix+Placebo and Pandemrix+Fluarix |
| PlaceboIntramuscular injection, 1 dose | Biological | Pandemrix+Fluarix and Pandemrix+Placebo, Pandemrix+Placebo and Pandemrix+Fluarix |
Primary outcome
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
9 secondary outcomes
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Time frame: Days 0, 21, 42, 182, 364
Number of Seroconverted Subjects
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Seroprotected Subjects
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Geometric Mean Fold Rise (GMFR)
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Number of Subjects With Titers Equal to or Above Titer 1:10
Time frame: Days 0, 21, 42, 182, 364
Number of Subjects With Solicited Local and General Symptoms
Time frame: Within 7 days (Day 0-Day 6) after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: From Day 0 to Day 83
Number of Subjects With Adverse Events of Specific Interest
Time frame: From Day 0 to Day 364
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 364
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22885014Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pandemrix (Influenza vaccine GSK2340272A) and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 2 sites in Sweden.
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 19 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 Mar 2011). 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 Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix (time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)). The study lists 3 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 NCT00968890, 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 20 Aug 2018.