InfluenzaPhase 3NCT00539864
Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
A Phase 3 study testing FluBlok Influenza Vaccination and TIV (Fluzone) Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 5 sites in United States.
Trial summary
The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluBlok Influenza Vaccination and TIV (Fluzone) Influenza Vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2007to Apr 2008
- 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 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 50 to 64.
- Females should be at least 2 years post-menopausal or sterile or practicing accepted form of birth control (including: condom with spermicidal, licensed hormonal contraceptive, abstinence, IUD or monogamous relationship with a vasectomized partner).
- Healthy, as determined by oral temperature <100.0°F, medical history, and medical assessment w/ brief physical evaluation by RN (if indicated) based on medical history.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedure.
Who cannot join
- Known allergy to eggs or other vaccine components.
- Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Any malignancy other than localized prostate cancer, diagnosed or treated actively during the past 5 years. Exceptions: Subjects with a history of lymphoproliferative disorder at any time in their life will be excluded, while subjects with a history of localized nonmelanotic skin cancer that has been completely removed during the past 5 years may be eligible.
- Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
- Diagnosis of or treatment for bipolar disorder, severe major depression, schizophrenia or other major psychotic disorder in the past 3 months that is associated with severely impaired judgment or cognition.
- History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Show all 16Show fewer
- Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Use of experimental vaccines or any influenza vaccine other than FluBlOk after May 31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere epidemic seasons.
- History of severe reactions following immunization with influenza virus vaccines.
- Moderate to severe acute illness or febrile illness (oral temperature greater than 100degreesF) within 1 week prior to vaccination.
- Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
- Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- History of alcohol or drug abuse in the last 5 years.
- History of Guillain-Barré Syndrome.
- Subject is not available for three (3) or more consecutive weeks during active influenza season.
- Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kaiser Permanente Pediatric Clinic - Fresno
Fresno, California, 93726
Kaiser Permanente Pediatric Clinic - Hayward
Hayward, California, 94545
Kaiser Permanente
Honolulu, Hawaii, 96814
Kaiser Permanente Pediatric Clinic - Roseville
Roseville, California, 95661
Kaiser Permanente Pediatric Clinic - Sacramento
Sacramento, California, 95823
About this study
Official title: Evaluation of Safety and Reactogenicity of FluBlok, Trivalent Recombinant Influenza Vaccine, and Comparison of the Immunogenicity, Efficacy and Effectiveness of FluBlok to a Licensed Egg-Grown Influenza Vaccine in Adults Aged 50 to 64
The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
Read the detailed description
Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.
Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.
- Conditions
- Influenza
- Being tested
- FluBlok Influenza Vaccination, TIV (Fluzone) Influenza Vaccination
- 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.
FluBlok Influenza VaccinationBiological
Also called FluBlok, rHA, rHA0, recombinant hemagglutinin
0.5mL dose for intramuscular injection
TIV (Fluzone) Influenza VaccinationBiological
Also called Fluzone, TIV
0.5mL dose for intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| FluBlok | Experimental | Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
135μg total Receives: Biological: FluBlok Influenza Vaccination |
| TIV (Fluzone) | Active comparator | Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
45μg total
(Fluzone, sanofi pasteur) Receives: Biological: TIV (Fluzone) Influenza Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.
Measured: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization
Secondary outcomes (3)
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.
Measured: Day 0 and Day 28
Percentage of Participants With Seroconversion
Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization
Measured: Day 28 following immunization at Day 0
Percentage of Participants With Seroprotection
Percentage of participants with (HAI titer greater than or equal to 40) at Day 28
Measured: Day 28 following immunization at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roger Baxter, MD, Principal investigator, Kaiser Permanenter Center for Vaccine Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539864
- Sponsor's protocol ID
- PSC06
- Status last verified
- Jul 2011
- First submitted
- 4 Oct 2007
- Last updated
- 27 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.
PubMed 21277410
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Reactogenicity of FluBlok, Trivalent Recombinant Influenza Vaccine, and Comparison of the Immunogenicity, Efficacy and Effectiveness of FluBlok to a Licensed Egg-Grown Influenza Vaccine in Adults Aged 50 to 64
- ClinicalTrials.gov ID
- NCT00539864
- Acronym / sponsor ID
- PSC06
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Posted 27 Jul 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 this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
Detailed description
Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.
Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.
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 |
|---|---|---|
| FluBlok | Experimental | Biological: FluBlok Influenza VaccinationRecombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 135μg total |
| TIV (Fluzone) | Active comparator | Biological: TIV (Fluzone) Influenza VaccinationLicensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 45μg total (Fluzone, sanofi pasteur) |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 50 to 64.
- Females should be at least 2 years post-menopausal or sterile or practicing accepted form of birth control (including: condom with spermicidal, licensed hormonal contraceptive, abstinence, IUD or monogamous relationship with a vasectomized partner).
- Healthy, as determined by oral temperature <100.0°F, medical history, and medical assessment w/ brief physical evaluation by RN (if indicated) based on medical history.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedure.
Key exclusion criteria (16 listed)
- Known allergy to eggs or other vaccine components.
- Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Any malignancy other than localized prostate cancer, diagnosed or treated actively during the past 5 years. Exceptions: Subjects with a history of lymphoproliferative disorder at any time in their life will be excluded, while subjects with a history of localized nonmelanotic skin cancer that has been completely removed during the past 5 years may be eligible.
- Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
- Diagnosis of or treatment for bipolar disorder, severe major depression, schizophrenia or other major psychotic disorder in the past 3 months that is associated with severely impaired judgment or cognition.
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 |
|---|---|---|
| FluBlok Influenza VaccinationAlso: FluBlok, rHA, rHA0, recombinant hemagglutinin0.5mL dose for intramuscular injection | Biological | FluBlok |
| TIV (Fluzone) Influenza VaccinationAlso: Fluzone, TIV0.5mL dose for intramuscular injection | Biological | TIV (Fluzone) |
Primary outcome
Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)
Time frame: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization
Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.
3 secondary outcomes
Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.
Time frame: Day 0 and Day 28
Percentage of Participants With Seroconversion
Time frame: Day 28 following immunization at Day 0
Percentage of Participants With Seroprotection
Time frame: Day 28 following immunization at Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21277410Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.
- Related InfoLink provided by the sponsor.
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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.
Roger Baxter, MD principal investigator
Kaiser Permanenter Center for Vaccine Development
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 FluBlok Influenza Vaccination and TIV (Fluzone) Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 5 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 16 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 Jul 2011. 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 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?
Yes. Results are posted in the registry (first posted 27 Jul 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 Participants With Reactogenicity (Solicited) Adverse Events (AEs) (time frame: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization). 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 NCT00539864, 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 27 Jul 2011.