Evaluation of live attenuated influenza vaccines in children 6-18 months of age: safety, immunogenicity, and efficacy. National Institute of Allergy and Infectious Diseases, Vaccine and Treatment Evaluation Program and the Wyeth-Ayerst ca Influenza Vaccine Investigators Group.
Live attenuated, cold-adapted (ca) monovalent and bivalent influenza A vaccines were evaluated in seronegative infants (ages 6-18 months) in a double-blind placebo-controlled trial to assess safety and immunogenicity. A total of 182 seronegative subjects received a single intranasal dose (10(6.2) TCID50) of ca A/Kawasaki/9/86 (H1N1) or ca A/Los Angeles/2/87 (H3N2), both as a bivalent vaccine, or placebo. Respiratory and systemic symptoms did not differ between groups after vaccination. Hemagglutination antibody seroconversions (> or = 1:8) to H3N2 exceeded 90%. In contrast, seroconversions to A/Kawasaki/9/86 (H1N1) were significantly less frequent in bivalent ca vaccine recipients (31%) than in monovalent ca H1N1 recipients (83%) (P < .002). During a subsequent H3N2 epidemic, nasal washes were cultured for viruses from any subject with respiratory illness. H3N2 infections documented by virus isolation were reduced by 65% in ca H3N2 recipients compared with placebo or ca HIM recipients (P = .01).
Gruber
W C
WC
Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2581, USA,
Belshe
R B
RB
King
J C
JC
Treanor
J J
JJ
Piedra
P A
PA
Wright
P F
PF
Reed
G W
GW
Anderson
E
E
Newman
F
F
D000222:Adaptation, Physiological; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral; D003080:Cold Temperature; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000254:growth & development / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D017817:Nasal Lavage Fluid / Q000821:virology; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D000956:Antigens, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated