原创力文档safety and immunogenicity following administration of a live, attenuated monovalent 2009 h1n1 influenza vaccine to children and adults in two randomized controlled trials安全性和免疫原性管理现场后,减单价2009 h1n1流感疫苗对儿童和成人在两个随机对照试验.pdfVIP
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safety and immunogenicity following administration of a live, attenuated monovalent 2009 h1n1 influenza vaccine to children and adults in two randomized controlled trials安全性和免疫原性管理现场后,减单价2009 h1n1流感疫苗对儿童和成人在两个随机对照试验
Safety and Immunogenicity Following Administration of
a Live, Attenuated Monovalent 2009 H1N1 Influenza
Vaccine to Children and Adults in Two Randomized
Controlled Trials
Raburn M. Mallory*, Elissa Malkin, Christopher S. Ambrose, Terramika Bellamy, Li Shi, Tingting Yi, Taff
Jones, George Kemble, Filip Dubovsky
MedImmune, LLC, Gaithersburg, Maryland, United States of America
Abstract
Background: The safety, tolerability, and immunogenicity of a monovalent intranasal 2009 A/H1N1 live attenuated influenza
vaccine (LAIV) were evaluated in children and adults.
Methods/Principal Findings: Two randomized, double-blind, placebo-controlled studies were completed in children (2–17
y) and adults (18–49 y). Subjects were assigned 4:1 to receive 2 doses of H1N1 LAIV or placebo 28 days apart. The primary
safety endpoint was fever $38.3uC during days 1–8 after the first dose; the primary immunogenicity endpoint was the
proportion of subjects experiencing a postdose seroresponse. Solicited symptoms and adverse events were recorded for 14
days after each dose and safety data were collected for 180 days post-final dose. In total, 326 children (H1N1 LAIV, n = 261;
placebo, n = 65) and 300 adults (H1N1 LAIV, n = 240; placebo, n = 60) were enrolled. After dose 1, fever $38.3uC occurred in
4 (1.5%) pediatric vaccine recipients and 1 (1.5%) placebo recipient (rate difference, 0%; 95% CI: –6.4%, 3.1%). No adults
experienced fever following dose 1. Seroresponse rates in children (H1N1 LAIV vs. placebo) were 11.1% vs. 6.3% after dose 1
(rate difference, 4.8%; 95% CI: –9.6%, 13.8%) and 32.0% vs. 14.5% after dose 2 (rate difference, 17.5%; 95% CI: 5.5%, 27.1%).
Seroresponse rates in adults were 6.1% vs. 0% (rate difference, 6.1%; 95% CI: –5.6%, 12.6%) and 14.9% vs. 5.6% (rate
difference, 9.3%; 95% CI: –0.8%, 16.3%) after dose 1 and dose 2, respectively. Solicited sympt
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