InfluenzaPhase 3NCT00216242
Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
A Phase 3 study testing Influenza virus vaccine (Fluviral) in people with Influenza, run by ID Biomedical Corporation, Quebec at 43 sites in United States.
Trial summary
The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza virus vaccine (Fluviral)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,400 participants
- Where
- 43 sitesUnited States
- Study dates
- Sep 2005to May 2007
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
Who cannot join
- Systolic BP >/= 140; diastolic BP >/= 90
- Uncontrolled medical or psychiatric illness (change in last 3 months)
- Cancer, or treatment for cancer within 3 years
- Cardio-pulmonary disease requiring chronic treatment
- Insulin dependent diabetes mellitus
- Renal dysfunction (creatinine >/= 1.7 mg/dL)
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- Hemoglobinopathies
- Clotting disorders that increase the risk of IM injections
- Immunosuppressive illnesses or drugs
- History of demyelinating disease (esp. Guillian-Barre syndrome)
- Employment in professions at high risk for influenza transmission
- Household contact with high-risk individuals
- Receipt of:
- Immunosuppressive drugs i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
- History of:
- Severe reactions to other influenza vaccines
- Allergy to egg proteins
- Sensitivity to mercurials
- Pregnancy/ high risk of pregnancy
- Positive urine pregnancy test before treatment
- Women of child-bearing potential without credible contraceptive plan
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Radiant Research
Anderson, South Carolina, 29611
Emory University
Atlanta, Georgia, 30322
Radiant Research
Atlanta, Georgia, 30342
Benchmark Research
Austin, Texas, 78705
Benchmark Research
Austin, Texas, 78728
Covance
Austin, Texas, 78752
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Advanced Clinical Research
Boise, Idaho, 83704
Radiant Research
Boise, Idaho, 83704
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Cincinnati, Ohio, 45236
Allergy and Asthma Research Associates
Dallas, Texas, 75231
Research Across America
Dallas, Texas, 75234
Radiant Research
Denver, Colorado, 80212
Brandywine Clinical Research
Downingtown, Pennsylvania, 19355
Anderson and Collins Clinical Research
Edison, New Jersey, 08817
Regional Clinical Research
Endwell, New York, 13760
Dwight D. Eisenhower Army Medical Center
Fort Eisenhower, Georgia, 30905-5650
Benchmark Research
Fort Worth, Texas, 76135
Preventive Intervention Center
Iowa City, Iowa, 52242-1009
Killeen Scott and White Regional Clinic
Killeen, Texas, 76543
Johnson County ClinTrials
Lenexa, Kansas, 66219
Longmont Med. Research Center
Longmont, Colorado, 80501
Miami Research Associates
Miami, Florida, 33173
Clinical Research Associates
Nashville, Tennessee, 37203
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Meridian Clinical Research
Omaha, Nebraska, 68134
University Clinical Research Associates
Pembroke Pines, Florida, 33024
Research Across America
Plano, Texas, 75093
Wake Research Associates
Raleigh, North Carolina, 27612
Rockville Internal Medicine Group
Rockville, Maryland, 20854
Benchmark Research
Sacramento, California, 95816
J. Lewis Research, Inc.
Salt Lake City, Utah, 84109
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121
Benchmark Research
San Angelo, Texas, 16904
Benchmark Research
San Francisco, California, 94102
Center for Health Studies
Seattle, Washington, 98101
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
National Carolina Children and Adult Clinical Research Foundation
Sylva, North Carolina, 28779
Omega Clinical Trials
Warwick, Rhode Island, 02886
J. Lewis Research
West Jordan, Utah, 84084
Carolina medical Trials
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.
Read the detailed description
Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.
- Conditions
- Influenza
- Being tested
- Influenza virus vaccine (Fluviral), Saline placebo
- Keywords
- influenza, vaccine, efficacy, safety, immunogenicity
- 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 virus vaccine (Fluviral)Biological
Saline placeboBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
Secondary outcomes (6)
Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
Rate of other adverse events through approximately 135 days post-treatment;
Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
Geometric mean influenza-specific antibody titers at 21 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 7,400 participants
Sponsor and investigators
- Lead sponsor
- ID Biomedical Corporation, Quebec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nancy Bouveret, MD, Study director, ID Biomedical of Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216242
- Sponsor's protocol ID
- IDB707-106
- Status last verified
- Dec 2006
- First submitted
- 20 Sep 2005
- Last updated
- 11 Dec 2006
- Results posted
- No
Publications
Jackson LA, Gaglani MJ, Keyserling HL, Balser J, Bouveret N, Fries L, Treanor JJ. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010 Mar 17;10:71. doi: 10.1186/1471-2334-10-71.
PubMed 20236548
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
- ClinicalTrials.gov ID
- NCT00216242
- Acronym / sponsor ID
- IDB707-106
- Conditions
- Influenza
- Keywords
- influenza, vaccine, efficacy, safety, immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,400 participants
- Lead sponsor
- ID Biomedical Corporation, QuebecIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- May 2007
- First posted
- 22 Sep 2005 (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 goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.
Detailed description
Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
Key exclusion criteria (21 listed)
- Systolic BP >/= 140; diastolic BP >/= 90
- Uncontrolled medical or psychiatric illness (change in last 3 months)
- Cancer, or treatment for cancer within 3 years
- Cardio-pulmonary disease requiring chronic treatment
- Insulin dependent diabetes mellitus
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 virus vaccine (Fluviral) | Biological | – |
| Saline placebo | Biological | – |
Primary outcome
Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
6 secondary outcomes
Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
Rate of other adverse events through approximately 135 days post-treatment;
Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
Geometric mean influenza-specific antibody titers at 21 days after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2006.
- Derived from this study: PubMed 20236548Jackson LA, Gaglani MJ, Keyserling HL, Balser J, Bouveret N, Fries L, Treanor JJ. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010 Mar 17;10:71. doi: 10.1186/1471-2334-10-71.
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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.
Nancy Bouveret, MD study director
ID Biomedical of Quebec
43 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 virus vaccine (Fluviral) in people with Influenza, run by ID Biomedical Corporation, Quebec at 43 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 3 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 11 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Results are not available in the source record.
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?
Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.. 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 NCT00216242, 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 11 Dec 2006.