Randomized, Double-Blind Controlled Phase 3 Trial Comparing the Immunogenicity of High-Dose and Standard-Dose Influenza Vaccine in Adults 65 Years of Age and Older
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作者:
Falsey, Ann R.
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机构:
Rochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Univ Rochester, Sch Med, Rochester, NY USARochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Falsey, Ann R.
[1
,2
]
Treanor, John J.
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Univ Rochester, Sch Med, Rochester, NY USARochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Treanor, John J.
[2
]
Tornieporth, Nadia
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Sanofi Pasteur, Swiftwater, PA USARochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Tornieporth, Nadia
[3
]
Capellan, Jose
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Sanofi Pasteur, Toronto, ON, CanadaRochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Capellan, Jose
[6
]
Gorse, Geoffrey J.
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机构:
St Louis Univ, St Louis, MO 63103 USA
Vet Affairs Med Ctr, St Louis Dept, St Louis, MO USARochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
Gorse, Geoffrey J.
[4
,5
]
机构:
[1] Rochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
[2] Univ Rochester, Sch Med, Rochester, NY USA
[3] Sanofi Pasteur, Swiftwater, PA USA
[4] St Louis Univ, St Louis, MO 63103 USA
[5] Vet Affairs Med Ctr, St Louis Dept, St Louis, MO USA
Background. Influenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed. Methods. A multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 mu g of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 mu g of hemagglutinin per strain) in adults >= 65 years of age. Results. HD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met noninferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate. Conclusions. There was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.
机构:
St Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Univ Tennessee, Hlth Sci Ctr, Dept Prevent Med, Memphis, TN 38103 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Hakim, Hana
Allison, Kim J.
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St Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Allison, Kim J.
Van de Velde, Lee-Ann
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St Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Van de Velde, Lee-Ann
Tang, Li
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St Jude Childrens Res Hosp, Dept Biostat, Memphis, TN 38101 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Tang, Li
Sun, Yilun
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St Jude Childrens Res Hosp, Dept Biostat, Memphis, TN 38101 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Sun, Yilun
Flynn, Patricia M.
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St Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Univ Tennessee, Hlth Sci Ctr, Dept Pediat, 50 N Dunlap St,Room 450R, Memphis, TN 38103 USA
Univ Tennessee, Hlth Sci Ctr, Dept Prevent Med, Memphis, TN 38103 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Flynn, Patricia M.
McCullers, Jonathan A.
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St Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
Univ Tennessee, Hlth Sci Ctr, Dept Pediat, 50 N Dunlap St,Room 450R, Memphis, TN 38103 USASt Jude Childrens Res Hosp, Dept Infect Dis, Mail Stop 600,262 Danny Thomas Pl, Memphis, TN 38105 USA
机构:
Shanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Feng, Yongliang
Chen, Zhuanzhuan
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Chen, Zhuanzhuan
Xie, Ruixue
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Xie, Ruixue
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Yao, Tian
Wu, Yuanting
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Wu, Yuanting
Yang, Feng
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Second Hosp Yuncheng, Dept Infect Dis, Yuncheng, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Yang, Feng
Yuan, Chenli
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Shanxi Prov Ctr Dis Control & Prevent, Dept STD & AIDS Control & Prevent, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Yuan, Chenli
Nie, Xiaoyong
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Shanxi Prov Ctr Dis Control & Prevent, Dept STD & AIDS Control & Prevent, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Nie, Xiaoyong
Wang, Fuzhen
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Chinese Ctr Dis Control & Prevent, Dept Natl Immunizat Program, Beijing, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Wang, Fuzhen
Liang, Xiaofeng
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Chinese Prevent Med Assoc, Beijing, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Liang, Xiaofeng
Wang, Suping
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan, Shanxi, Peoples R China
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Feng, Yongliang
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Yao, Tian
Chang, Yue
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Chang, Yue
Gao, Linying
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Gao, Linying
Shao, Zhihong
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shao, Zhihong
Dong, Shuang
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Dong, Shuang
Wu, Yuanting
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Wu, Yuanting
Shi, Xiaohong
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
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Shi, Xiaohong
Shi, Jing
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shi, Jing
Feng, Dan
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Feng, Dan
Cheng, Yanpeng
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Cheng, Yanpeng
Pan, Minghu
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Pan, Minghu
Li, Chunxia
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Li, Chunxia
Wang, Jun
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Wang, Jun
Lan, Guanghua
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Guangxi Ctr Dis Control & Prevent, Nanning 530028, Guangxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Lan, Guanghua
Lu, Hongyan
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Guangxi Ctr Dis Control & Prevent, Nanning 530028, Guangxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Lu, Hongyan
Wang, Peiyu
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Ningming Ctr Dis Control & Prevent, Ningming 532500, Guangxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Wang, Peiyu
Xiang, Shaomi
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Ningming Ctr Dis Control & Prevent, Ningming 532500, Guangxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
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Nong, Lihua
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Ningming Ctr Dis Control & Prevent, Ningming 532500, Guangxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Nong, Lihua
Wang, Fuzhen
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Chinese Ctr Dis Control & Prevent, Beijing 100021, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Wang, Fuzhen
Liang, Xiaofeng
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Chinese Prevent Med Assoc, Beijing 100021, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Liang, Xiaofeng
Wang, Suping
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Shanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China
Shanxi Med Univ, Ctr Clin Epidemiol & Evidence Based Med, Taiyuan 030001, Shanxi, Peoples R ChinaShanxi Med Univ, Sch Publ Hlth, Taiyuan 030001, Shanxi, Peoples R China