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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
602
0.5mL dose for intramuscular injection
0.5mL dose for intramuscular injection
Kaiser Permanente Pediatric Clinic - Fresno
Fresno, California, United States
Kaiser Permanente Pediatric Clinic - Hayward
Hayward, California, United States
Kaiser Permanente Pediatric Clinic - Roseville
Roseville, California, United States
Kaiser Permanente Pediatric Clinic - Sacramento
Sacramento, California, United States
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.
Time frame: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization
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.
Time frame: 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
Time frame: 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
Time frame: Day 28 following immunization at Day 0
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Kaiser Permanente
Honolulu, Hawaii, United States