| Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. | |
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MedLine Citation:
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PMID: 23134570 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Please cite this paper as: Li et al. (2012) Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza and Other Respiratory Viruses DOI: 10.1111/irv.12028. Objectives The goal of this double-blind, randomized, controlled clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent split-virion 2009 pandemic influenza A/H1N1 vaccine without adjuvant in Chinese infants aged 6-35 months. Design and setting Subjects were randomly assigned to receive either a 2009 pandemic (H1N1) vaccine containing 7.5 or 15 μg haemagglutinin (HA) or a seasonal influenza vaccine. 2 doses of the H1N1 vaccines or the seasonal influenza vaccine were given 21 days apart in younger infants aged 6-23 months or older infants aged 24-35 months. Sample Serum samples were collected immediately before the first injection and before and 21 days after the second injection. Main outcome measures Primary outcomes were haemagglutinin inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitoring throughout the study. Results The first vaccination of 7.5 μg and 15 μg H1N1 vaccine induced seroprotective antibody titers (HI titers ≥ 1: 40) in 42.9-57.4% of younger infants and 49.1-61.0% older infants. Immune responses after completion of the two dose schedule were comparable in both age groups with seroprotective rates of 91-98% in each vaccine and age group and GMTs of 173-263. The H1N1 vaccine elicited similar rates of local and systemic adverse reactions as the seasonal influenza vaccine. Conclusions The 2009 pandemic influenza A /H1N1 vaccine were highly immunogenic in infants aged 6-35 months, and displayed a safety and reactogenicity profile similar to the seasonal influenza vaccine. Trial registration ClinicalTrial.gov identifier: NCT01047202. |
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Authors:
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Yan-Ping Li; Wei Li; Xiao-Feng Liang; Yan Liu; Xiao-Chun Huang; Chang-Gui Li; Rong-Cheng Li; Jun-Zhi Wang; Hua-Qing Wang; Wei-Dong Yin |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-11-8 |
Journal Detail:
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Title: Influenza and other respiratory viruses Volume: - ISSN: 1750-2659 ISO Abbreviation: Influenza Other Respi Viruses Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-11-8 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101304007 Medline TA: Influenza Other Respi Viruses Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 Blackwell Publishing Ltd. |
Affiliation:
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Guangxi Centers for Diseases Control and Prevention, Nanning. National Institutes for Food and Drug Control, Beijing. Chinese Center for Disease Control and Prevention, Beijing. Sinovac Biotech Co. Ltd, Beijing. Lingchuan Center for Disease Control and Prevention, Guilin, China. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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