Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
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
1 other identifier
interventional
602
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
July 27, 2011
CompletedJuly 27, 2011
July 1, 2011
7 months
October 4, 2007
May 16, 2011
July 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Day 0 and Day 28
Percentage of Participants With Seroconversion
Day 28 following immunization at Day 0
Percentage of Participants With Seroprotection
Day 28 following immunization at Day 0
Study Arms (2)
FluBlok
EXPERIMENTALRecombinant 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 COMPARATORLicensed 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)
Interventions
0.5mL dose for intramuscular injection
0.5mL dose for intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kaiser Permanente Pediatric Clinic - Fresno
Fresno, California, 93726, United States
Kaiser Permanente Pediatric Clinic - Hayward
Hayward, California, 94545, United States
Kaiser Permanente Pediatric Clinic - Roseville
Roseville, California, 95661, United States
Kaiser Permanente Pediatric Clinic - Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente
Honolulu, Hawaii, 96814, United States
Related Publications (1)
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.
PMID: 21277410RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa M. Dunkle, M.D., Chief Medical Officer
- Organization
- Protein Sciences Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Baxter, MD
Kaiser Permanenter Center for Vaccine Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 5, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
July 27, 2011
Results First Posted
July 27, 2011
Record last verified: 2011-07