Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial.
BACKGROUND
In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children.


OBJECTIVE
To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.


METHODS
Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia.


METHODS
Intramuscular injection of 15 microg or 30 microg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days apart.


METHODS
Hemagglutination inhibition assay to estimate the proportion of participants with antibody titers of 1:40 or greater, seroconversion, or a significant antibody titer increase, and factor increase in geometric mean titer. Assessments of solicited adverse events during 7 days and unsolicited adverse events for 21 days after each vaccination.


RESULTS
Following the first dose of vaccine, antibody titers of 1:40 or greater were observed in 161 of 174 infants and children in the 15-microg group (92.5%; 95% confidence interval [CI], 87.6%-95.6%) and in 168 of 172 infants and children in the 30-microg group (97.7%; 95% CI, 94.2%-99.1%). Corresponding seroconversion rates were 86.8% (95% CI, 80.9%-91.0%) and 94.2% (95% CI, 89.6%-96.8%), and factor increases in geometric mean titer were 13.6 (95% CI, 11.8-15.6) and 18.3 (95% CI, 15.7-21.4). All participants demonstrated antibody titers of 1:40 or greater after the second vaccine dose. Immune responses were robust regardless of age, baseline serostatus, or seasonal influenza vaccination status. The majority of adverse events were mild to moderate in severity.


CONCLUSIONS
One 15-microg dose of vaccine was immunogenic in infants and children starting at 6 months of age and vaccine-associated reactions were mild to moderate in severity.


BACKGROUND
clinicaltrials.gov Identifier: NCT00940108.
Nolan
Terry
T
Vaccine and Immunization Research Group, School of Population Health, University of Melbourne, and Murdoch Children's Research Institute, Victoria, Australia. t.nolan@unimelb.edu.au
McVernon
Jodie
J
Skeljo
Maryanne
M
Richmond
Peter
P
Wadia
Ushma
U
Lambert
Stephen
S
Nissen
Michael
M
Marshall
Helen
H
Booy
Robert
R
Heron
Leon
L
Hartel
Gunter
G
Lai
Michael
M
Basser
Russell
R
Gittleson
Charmaine
C
Greenberg
Michael
M
D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D016037:Single-Blind Method
D000914:Antibodies, Viral; D007252:Influenza Vaccines