Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18–49 Years of Age
Open Access
- 9 September 2017
- journal article
- research article
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 216 (10), 1219-1226
- https://doi.org/10.1093/infdis/jix478
Abstract
Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria. A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly with a standard-dose, egg-grown, quadrivalent-inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18–49 years of age. The coprimary endpoints for noninferiority were hemagglutination inhibition seroconversion rates and postvaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for 7 days, other safety events collected for 28 days, and serious or medically attended adverse events collected for 6 months after vaccination comprised the safety evaluation. The immunogenicity of RIV4 was comparable to that of IIV4; the coprimary noninferiority criteria were met for 3 antigens, and the antibody responses to the fourth antigen, influenza B/Brisbane/60/2008, were low in each group, making comparisons uninterpretable. Systemic and injection site reactions were mild, transient, and similar in each group, whereas none of the spontaneously reported adverse events, serious or nonserious, were considered related to study vaccine. This first head-to-head comparison of recombinant versus inactivated quadrivalent influenza vaccines in 18–49 year old adults showed comparable immunogenicity, safety, and tolerability for both vaccines.Keywords
This publication has 22 references indexed in Scilit:
- Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or OlderNew England Journal of Medicine, 2017
- Influenza immunization elicits antibodies specific for an egg-adapted vaccine strainNature Medicine, 2016
- Randomized comparison of the safety of Flublok® versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥50 years of ageVaccine, 2015
- Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adultsTherapeutic Advances in Vaccines, 2015
- Low 2012–13 Influenza Vaccine Effectiveness Associated with Mutation in the Egg-Adapted H3N2 Vaccine Strain Not Antigenic Drift in Circulating VirusesPLOS ONE, 2014
- Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok®) against influenza in healthy adults: A randomized, placebo-controlled trialVaccine, 2011
- A fast track influenza virus vaccine produced in insect cellsJournal of Invertebrate Pathology, 2011
- 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 ageVaccine, 2011
- Efficacy of Inactivated Influenza A Virus (H3N2) Vaccines Grown in Mammalian Cells or Embryonated EggsThe Journal of Infectious Diseases, 1989
- Structural changes in the haemagglutinin which accompany egg adaptation of an influenza A(H1N1) virusVirology, 1987