RT Journal Article
T1 Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults.
A1 Claeys, Carine
A1 Drame, Mamadou
A1 García-Sicilia, José
A1 Zaman, Khalequ
A1 Carmona, Alfonso
A1 Tran, Phu My
A1 Miranda, Mariano
A1 Martinón-Torres, Federico
A1 Thollot, Franck
A1 Horn, Michael
A1 Schwarz, Tino F
A1 Behre, Ulrich
A1 Merino, José M
A1 Sadowska-Krawczenko, Iwona
A1 Szymański, Henryk
A1 Schu, Peter
A1 Neumeier, Elisabeth
A1 Li, Ping
A1 Jain, Varsha K
A1 Innis, Bruce L
K1 Adults
K1 Children
K1 Immunogenicity
K1 Infants
K1 Influenza vaccine
K1 Investigational
K1 Manufacturing
K1 Quadrivalent
K1 Reactogenicity
K1 Safety
AB GSK has modified the licensed monovalent bulk manufacturing process for its split-virion inactivated quadrivalent influenza vaccine (IIV4) to harmonize the process among different strains, resulting in an increased number of finished vaccine doses, while compensating for the change from inactivated trivalent influenza vaccine (IIV3) to IIV4. To confirm the manufacturing changes do not alter the profile of the vaccine, a clinical trial was conducted to compare IIV4 made by the currently licensed process with a vaccine made by the new (investigational) process (IIV4-I). The main objectives were to compare the reactogenicity and safety of IIV4-I versus IIV4 in all age groups, and to demonstrate the non-inferiority of the hemagglutination-inhibition (HI) antibody responses based on the geometric mean titer ratio of IIV4-I versus IIV4 in children. The Phase III, randomized, double-blind, multinational study included three cohorts: adults (18-49 years; N = 120), children (3-17 years; N = 821), and infants (6-35 months; N = 940). Eligible subjects in each cohort were randomized 1:1 to receive IIV4-I or IIV4. Both vaccines contained 15 μg of hemagglutinin antigen for each of the four seasonal virus strains. Adults and vaccine-primed children received one dose of vaccine, and vaccine-unprimed children received two doses of vaccine 28 days apart. All children aged ≥9 years were considered to be vaccine-primed and received one dose of vaccine. The primary immunogenicity objective of the study was met in demonstrating immunogenic non-inferiority of IIV4-I versus IIV4 in children. The IIV4-I was immunogenic against all four vaccine strains in each age cohort. The reactogenicity and safety profile of IIV4-I was similar to IIV4 in each age cohort, and there was no increase in the relative risk of fever (≥38 °C) with IIV4-I versus IIV4 within the 7-day post-vaccination period in infants (1.06; 95% Confidence Interval: 0.75, 1.50; p = 0.786). The study demonstrated that in adults, children, and infants, the IIV4-I made using an investigational manufacturing process was immunogenic with a reactogenicity and safety profile that was similar to licensed IIV4. These results support that the investigational process used to manufacture IIV4-I is suitable to replace the current licensed process. ClinicalTrials.gov: NCT02207413 ; trial registration date: August 4, 2014.
YR 2018
FD 2018-04-18
LK http://hdl.handle.net/10668/12365
UL http://hdl.handle.net/10668/12365
LA en
DS RISalud
RD Apr 7, 2025