A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children.
BACKGROUND
This study (NCT00383123) compared the immunogenicity and safety of 2 trivalent inactivated influenza vaccines: Fluarix [GlaxoSmithKline (study vaccine)] and Fluzone [Sanofi Pasteur (control vaccine)] in children 6 months to <18 years.


METHODS
Children, stratified by age and randomized, received either study (N = 2115) or control vaccine (N = 1210) at day 0 (and day 28 for previously unvaccinated children younger than 9 years). Children 6 months to <5 years comprised the according-to-protocol (ATP) cohort for immunogenicity, whereas the reactogenicity/safety group included all children 6 months to <18 years. The study aimed to demonstrate immunologic noninferiority of study vaccine versus control vaccine.


RESULTS
For children 6 months to <5 years, the predefined noninferiority criteria were not reached, mainly due to the differences in immune response in children 6 months to <3 years with no influenza vaccination history. All reactogenicity/safety endpoints were within the same range in both vaccine groups.


CONCLUSIONS
The study vaccine demonstrated a good safety and reactogenicity profile; however, it did not meet the predefined noninferiority criteria in children 6 months to <5 years. The study vaccine was as immunogenic as the control vaccine in children aged 3 to <5 years.
Baxter
Roger
R
Kaiser Permanente Vaccine Study Center, Oakland, CA, USA. roger.baxter@kp.org
Jeanfreau
Robert
R
Block
Stanley L
SL
Blatter
Mark
M
Pichichero
Michael
M
Jain
Varsha K
VK
Dewé
Walthère
W
Innis
Bruce L
BL
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D014481:United States; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated