InfluenzaPhase 3NCT00380211
Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
A Phase 3 study testing Influenza vaccine (A/H3N2, A/H1N1, and B strains) and Fluarix in people with Influenza, run by GlaxoSmithKline at 6 sites in United States.
Trial summary
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations. 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?
- Influenza vaccine (A/H3N2, A/H1N1, and B strains) and Fluarix
- Type of treatment
- Vaccines
- How many people
- 660 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2006to Nov 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults (≥18 yrs)
- Stable health status
- Provide informed consent
- Access to direct phone service (NOT a pay phone or a common-use phone service)
- Eligible females must have a negative pregnancy test
Who cannot join
- Febrile illness (>38.0°C oral temperature)
- High blood pressure (≥140/90 mmHg)
- Significant acute or chronic
- Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
- Immunosuppressive condition (confirmed or suspected)
- Renal impairment
Show all 22Show fewer
- Hepatic dysfunction
- Complicated insulin-dependent diabetes mellitus
- Unstable cardiopulmonary disease
- Blood dyscrasias
- Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
- History of demyelinating disease
- Active neurological disorder
- Significant alcohol or drug abuse
- Significant coagulation disorder (prophylactic antiplatelet medications allowed)
- Influenza vaccine administrated within 6 months prior to study vaccination
- Administration of any other vaccine from 30 days prior to the end of the study
- Use of non-registered drug within 30 days prior to study vaccination
- Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
- History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
- Pregnant or nursing female subjects
- Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Binghamton, New York, 13901
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Miami, Florida, 33173
About this study
Official title: A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
Read the detailed description
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.
- Conditions
- Influenza
- Being tested
- Influenza vaccine (A/H3N2, A/H1N1, and B strains), Fluarix
- Keywords
- Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccine (A/H3N2, A/H1N1, and B strains)Biological
FluarixBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
Secondary outcomes (2)
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 660 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
- NCT00380211
- Sponsor's protocol ID
- IDB-200-001
- Status last verified
- Oct 2016
- First submitted
- 21 Sep 2006
- Last updated
- 7 Oct 2016
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.
- ClinicalTrials.gov ID
- NCT00380211
- Acronym / sponsor ID
- IDB-200-001
- Conditions
- Influenza
- Keywords
- Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 25 Sep 2006 (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 trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
Detailed description
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adults (≥18 yrs)
- Stable health status
- Provide informed consent
- Access to direct phone service (NOT a pay phone or a common-use phone service)
- Eligible females must have a negative pregnancy test
Key exclusion criteria (22 listed)
- Febrile illness (>38.0°C oral temperature)
- High blood pressure (≥140/90 mmHg)
- Significant acute or chronic
- Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
- Immunosuppressive condition (confirmed or suspected)
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 |
|---|---|---|
| Influenza vaccine (A/H3N2, A/H1N1, and B strains) | Biological | – |
| Fluarix | Biological | – |
Primary outcome
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
2 secondary outcomes
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period
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 7 Oct 2016.
- 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
6 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 Influenza vaccine (A/H3N2, A/H1N1, and B strains) and Fluarix in people with Influenza, run by GlaxoSmithKline at 6 sites in United States.
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 22 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 7 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 6 sites in United States. 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?
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?
21 days after vaccination: seroconversion rate, seroprotection rate,. 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?
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 7 Oct 2016.