Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial.
BACKGROUND
Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.


METHODS
Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.


RESULTS
Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.


CONCLUSIONS
QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.
Hospital General de Durango, Durango, Mexico. Electronic address: jctinoco@prodigy.net.mx.
Juan Carlos
JC
Tinoco
Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
Noris
N
Pavia-Ruz
National Institute of Public Health, Cuernavaca, Morelos, Mexico.
Aurelio
A
Cruz-Valdez
Secretaria de Salud del Estado de Mexico, Zumpango, Mexico.
Carlos
C
Aranza Doniz
GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
Vijayalakshmi
V
Chandrasekaran
GlaxoSmithKline Vaccines, Rixensart, Belgium.
Walthère
W
Dewé
GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
Aixue
A
Liu
GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
Bruce L
BL
Innis
GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
Varsha K
VK
Jain
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D004311:Double-Blind Method; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D053122:Influenza A Virus, H3N2 Subtype; D009981:Influenza B virus; D007252:Influenza Vaccines / Q000145:classification / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D015164:Vaccines, Inactivated / Q000627:therapeutic use; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
Inactivated quadrivalent influenza vaccine; Seasonal influenza; Victoria lineage; Yamagata lineage