Influenza VaccinesPhase 4NCT00586469
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
A Phase 4 study testing Fluviral in people with Influenza Vaccines, run by GlaxoSmithKline at 8 sites in Canada.
Trial summary
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines
- What is being tested?
- Fluviral
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 8 sitesCanada
- Study dates
- 14 Dec 2007to 14 Jan 2008
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Who cannot join
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
- Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- A history of any demyelinating disease including Guillain-Barré syndrome.
- Presence of an active neurological disorder.
Show all 15Show fewer
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
- Receipt of an influenza vaccine within 6 months prior to study enrollment.
- Administration of any vaccines within 30 days prior to study enrollment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6
GSK Investigational Site
Toronto, Ontario, M1L 4S4
GSK Investigational Site
Toronto, Ontario, M9W 4L6
About this study
Official title: Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
- Conditions
- Influenza Vaccines
- Being tested
- Fluviral
- Keywords
- 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.
FluviralBiological
One dose, Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Old Bulk | Experimental | This group receives a full dose of Fluviral made from aged bulk material Receives: Biological: Fluviral |
| New Bulk | Active comparator | This group receives a full dose of Fluviral made from new material Receives: Biological: Fluviral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
GMTs for H1 strain is addressed as a secondary endpoint
Measured: At Day 21
Secondary outcomes (9)
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
The table contains GMTs of the H1 strains at Day 0 \& 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)
Measured: At Days 0 and 21
Number of Participants Who Seroconverted.
The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.
Measured: At Day 21.
Number of Seroprotected Participants.
The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.
Measured: At Days 0 and 21
Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.
Measured: At Day 21 compared to Day 0
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor."
Measured: At Day 21 compared to Day 0
Number of Participants Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Measured: During the 4-day follow up period following vaccination.
Number of Participants Reporting Solicited General Symptoms
Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face
Measured: During the 4-day period following each vaccination.
Number of Participants Reporting Unsolicited Adverse Events (AE).
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 21-day period following each vaccination.
Number of Participants Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Within 21 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study start14 Dec 2007
- Primary completion14 Jan 2008
- Study completion14 Jan 2008
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 Influenza VaccinesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 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
- NCT00586469
- Sponsor's protocol ID
- 111258
- Status last verified
- Jun 2019
- First submitted
- 21 Dec 2007
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years
- ClinicalTrials.gov ID
- NCT00586469
- Acronym / sponsor ID
- 111258
- Conditions
- Influenza Vaccines
- Keywords
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2007 (actual)
- Primary completion
- 14 Jan 2008 (actual)
- Study completion
- 14 Jan 2008 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 28 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old Bulk | Experimental | Biological: FluviralThis group receives a full dose of Fluviral made from aged bulk material |
| New Bulk | Active comparator | Biological: FluviralThis group receives a full dose of Fluviral made from new material |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Key exclusion criteria (15 listed)
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
- Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- A history of any demyelinating disease including Guillain-Barré syndrome.
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 |
|---|---|---|
| FluviralOne dose, Intramuscular injection | Biological | New Bulk, Old Bulk |
Primary outcome
Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
Time frame: At Day 21
GMTs for H1 strain is addressed as a secondary endpoint
9 secondary outcomes
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Time frame: At Days 0 and 21
Number of Participants Who Seroconverted.
Time frame: At Day 21.
Number of Seroprotected Participants.
Time frame: At Days 0 and 21
Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1
Time frame: At Day 21 compared to Day 0
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
Time frame: At Day 21 compared to Day 0
Number of Participants Reporting Solicited Local Symptoms
Time frame: During the 4-day follow up period following vaccination.
Number of Participants Reporting Solicited General Symptoms
Time frame: During the 4-day period following each vaccination.
Number of Participants Reporting Unsolicited Adverse Events (AE).
Time frame: During the 21-day period following each vaccination.
Number of Participants Reporting Serious Adverse Events (SAE)
Time frame: Within 21 days after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- 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.
Related trials for Influenza Vaccines
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
Enrolling by invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluviral in people with Influenza Vaccines, run by GlaxoSmithKline at 8 sites in Canada.
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 4 inclusion and 15 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 28 May 2009). 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?
Geometric Mean Titers (GMTs) of Anti-H3 and B Strains (time frame: At Day 21). 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 27 Jun 2019.