Randomized comparison of the safety of Flublok® versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥50 years of age

Vaccine

Volumn 33, Issue 48, 2015, Pages 6622-6628

  Izikson, Ruvim ^a   Leffell, David J ^b   Bock, S Allan ^c   Patriarca, Peter A ^d   Post, Penny ^a   Dunkle, Lisa M ^a   Cox, Manon M J ^a  

^a Protein Sciences Corp   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^d BIOLOGICS CONSULTING GROUP INC   (United States)

Author keywords

Allergic reaction; Flublok; Influenza vaccine; Recombinant hemagglutinin vaccine

Indexed keywords

INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; VIRUS ANTIBODY;

ADULT; AGED; ARTHRALGIA; ARTICLE; BODY TEMPERATURE; CHILL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG APPROVAL; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; FATIGUE; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; HYPERSENSITIVITY; IMMUNOGENICITY; INFLUENZA VACCINATION; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MYALGIA; NAUSEA; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SWELLING; URTICARIA; VERY ELDERLY; ADVERSE DRUG REACTION; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; HEMAGGLUTINATION INHIBITION TEST; IMMUNOLOGY; INFLUENZA, HUMAN; NORMAL HUMAN; VACCINATION;

AGED; AGED, 80 AND OVER; ANTIBODIES, VIRAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEALTHY VOLUNTEERS; HEMAGGLUTINATION INHIBITION TESTS; HEMAGGLUTININ GLYCOPROTEINS, INFLUENZA VIRUS; HUMANS; HYPERSENSITIVITY; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; VACCINATION;

EID: 84949870503     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.10.097     Document Type: Article

References (21)

1. Patriarca P., Weber J.A., Parker R.A., et al. Efficacy of influenza vaccine in nursing homes. Reduction in illness and complications during influenza A(H3N2) epidemic. J Amer Med Assn 1985, 253:1136-1139.
2. Centers for Disease Control Prevention Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2011, 60(Aug (33)):1128-1132.
3. Skowronski D.M., Janjua N.Z., De Serres G., et al. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS ONE 2014, 9:e92153.
4. Cox M.M.J., Hashimoto Y. A fast track influenza virus vaccine produced in insect cells. J Invert Pathol 2011, 107:S31-S34.
5. Centers for Disease Control and Prevention CDC Advisory Committee recommends an influenza vaccine option for persons with egg allergy 2013, 〈cdc.gov/flu〉 [Online]. 〈http://www.cdc.gov/media/releases/2013/a0620-FluBlok.html〉.
6. Powers D.C., Smith G.E., Anderson E.L., et al. Influenza A virus vaccines containing purified recombinant H3 hemagglutinin are well-tolerated and induce protective immune responses in healthy adults. J Infect Dis 1995, 171:1595-1599.
7. Powers D.C., McElhaney J.E., Florendo O.A., et al. Humoral and cellular immune responses following immunization with purified recombinany hemagglutinin from influenza A (H3N2) virus. J Infect Dis 1997, 175:342-351.
8. Lakey D.L., Treanor J.J., Betts R.F., et al. Recombinant baculovirus influenza A hemagglutinin vaccines are well tolerated and immunogenic in healthy adults. J Infect Dis 1996, 174:838-841.
9. Treanor J.J., Schiff G.M., Couch R.B., et al. Dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults. J Infect Dis 2006, 193:1223-1228.
10. Treanor J.J., El Sahly H.M., King J., et al. Protective efficacy of a trivalent, insect cell-expressed, recombinant hemagglutinin protein vaccine (FluBlok) against culture confirmed influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine 2011, 13(29):7733-7739.
11. Treanor J.J., Schiff G.M., Hayden F.G., et al. Safety and immunogenicity of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA 2007, 297:1577-1582.
12. Keitel W.A., Treanor J.J., El Sahly H.M., et al. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccines (TIVs) among persons ≥65 years old. Vaccine 2010, 28:379-385.
13. Baxter R., Patriarca P.A., Ensor K. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine 2011, 29:2272-2278.
14. bioCSL (CSL Ltd.) AFLURIA package insert 2014, 〈fda.gov.〉 [Online] 〈fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM263239.pdf〉.
15. Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990, 9:1447-1454.
16. Izurieta H.S., Thadani N., Shay D.K. Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data: a retrospective cohort analysis. Lancet Infect Dis 2015, 15:295-300.
17. DiazGranados C.A., Dunning A.J., Kimmel M., et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med 2014, 371:635-645.
18. MedCalc. Version 15.10 - Last modified: October 22, 2015. [Online] 〈http://www.medcalc.org/calc/relative_risk.php〉.
19. Sanofi-Pasteur Fluzone package insert 2014.
20. Woo E.J. Egg-free influenza vaccine linked to allergic reaction: reports to the US Vaccine Adverse Event Reporting System. Clin Infect Dis 2015, 60:777-780.
21. CDC/FDA. VAERS. [Online] [Cited: December 11, 2014] 〈https://vaers.hhs.gov/index〉.