Safety and immunogenicity of low and high doses of trivalent live cold-adapted influenza vaccine administered intranasally as drops or spray to healthy children.
The safety and immunogenicity of various doses of trivalent cold-adapted influenza vaccine (CAIV-T) administered intranasally by drops or spray to children aged 18-71 months was examined. CAIV-T containing A/Johannesburg/33/94 (H3N2), B/Panama/45/90, and A/Texas/36/91 (H1N1) was safe and well-tolerated. At the highest CAIV-T dose, 90%, 50%, and 16% of initially seronegative subjects seroconverted to the H3N2, B, and H1N1 antigens, respectively. The lower immunologic response to the H1N1 vaccine strain compared with the other strains was associated with a low frequency of H1N1 shedding. No statistically significant differences in reactogenicity or immunogenicity were detected between subjects who received CAIV-T by drops or spray. In conclusion, this CAIV-T was safe and induced acceptable immunologic responses to 2 of the 3 vaccine strains. Studies are needed to confirm previous observations that receipt of two doses of this vaccine results in immunologic responses that confer protection to all 3 circulating influenza virus strains.
King
J C
JC
University of Maryland School of Medicine, Baltimore, USA.
Lagos
R
R
Bernstein
D I
DI
Piedra
P A
PA
Kotloff
K
K
Bryant
M
M
Cho
I
I
Belshe
R B
RB
D000281:Administration, Intranasal; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D017201:Virus Shedding
D007252:Influenza Vaccines