[Study of tolerability and reactogenicity of pandemic vaccines against influenza type A/H1N1].
OBJECTIVE
To study tolerability and safety of pandemic vaccines against influenza A/H1N1 "INFLUVIR" and "PANDEFLU" on limited group of volunteers during phase I clinical trial.


METHODS
Thirty healthy volunteers were participated in phase I clinical trial. Clinical and laboratory tests of volunteers randomized to 2 groups (20 persons received vaccine and 10 persons - placebo) were performed. "INFLUVIR" vaccine was administered by intranasal route. Volunteers were hospitalized and followed up for development of local and systemic adverse events during 7 days after vaccination. "PANDEFLU" was administered intramuscularly; vaccinees were followed for 7 days in outpatient settings. RESULTS. Phase I clinical trial showed good tolerability and low reactogenicity of "INFLUVIR" and "PANDEFLU" vaccines. There were no moderate and severe local and systemic adverse events registered.


CONCLUSIONS
On the basis of performed phase I clinical trial, phase II trial was recommended to perform in order to assess the reactogenicity, safety and immunogenicity of studied vaccines.
Mironov
A N
AN
Bushmenkov
D S
DS
Dyldina
N V
NV
Romanova
A A
AA
Tsaan
A A
AA
Kiselev
O I
OI
Erofeeva
M K
MK
Stukova
M A
MA
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects
D007252:Influenza Vaccines; C550277:Influvir; D014613:Vaccines, Attenuated