Safety and Immunogenicity of Full-Dose Trivalent Inactivated Influenza Vaccine (TIV) Compared With Half-Dose TIV Administered to Children 6 Through 35 Months of Age.
BACKGROUND
Children 6 through 35 months of age are recommended to receive half the dose of influenza vaccine compared with older children and adults.


METHODS
This was a 6-site, randomized 2:1, double-blind study comparing full-dose (0.5 mL) trivalent inactivated influenza vaccine (TIV) with half-dose (0.25 mL) TIV in children 6 through 35 months of age. Children previously immunized with influenza vaccine (primed cohort) received 1 dose, and those with no previous influenza immunizations (naive cohort) received 2 doses of TIV. Local and systemic adverse events were recorded. Sera were collected before immunization and 1 month after last dose of TIV. Hemagglutination inhibition antibody testing was performed.


RESULTS
Of the 243 subjects enrolled (32 primed, 211 naive), data for 232 were available for complete analysis. No significant differences in local or systemic reactions were observed. Few significant differences in immunogenicity to the 3 vaccine antigens were noted. The immune response to H1N1 was significantly higher in the full-dose group among primed subjects. In the naive cohort, the geometric mean titer for all 3 antigens after 2 doses of TIV were significantly higher in the 12 through 35 months compared with the 6 through 11 months age group.


CONCLUSIONS
Our study confirms the safety of full-dose TIV given to children 6 through 35 months of age. An increase in antibody responses after full- versus half-dose TIV was not observed, except for H1N1 in the primed group. Larger studies are needed to clarify the potential for improved immunogenicity with higher vaccine doses. Recommending the same dose could simplify the production, storage, and administration of influenza vaccines.
Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Natasha B
NB
Halasa
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio.
Michael A
MA
Gerber
Center for Vaccine Development, University of Maryland, Baltimore.
Andrea A
AA
Berry
Department of Medicine, St Louis University, Missouri.
Edwin L
EL
Anderson
Department of Medicine, University of Iowa, Iowa City.
Patricia
P
Winokur
Department of Pediatrics, Emory University, Atlanta, Georgia.
Harry
H
Keyserling
Department of Pediatrics, Emory University, Atlanta, Georgia.
Allison Ross
AR
Eckard
EMMES Corporation, Rockville, Maryland.
Heather
H
Hill
EMMES Corporation, Rockville, Maryland.
Mark C
MC
Wolff
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio.
Monica M
MM
McNeal
Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Kathryn M
KM
Edwards
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio.
David I
DI
Bernstein
D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D000071497:Immunogenicity, Vaccine; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards*; D007251:Influenza, Human / Q000517:prevention & control; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards*
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
children; inactivated; influenza; vaccine