Document Detail


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.
MedLine Citation:
PMID:  23134570     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  JOURNAL ARTICLE     Date:  2012-11-8
Journal Detail:
Title:  Influenza and other respiratory viruses     Volume:  -     ISSN:  1750-2659     ISO Abbreviation:  Influenza Other Respi Viruses     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101304007     Medline TA:  Influenza Other Respi Viruses     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Affiliation:
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.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  The Tomato cis-Prenyltransferase Gene Family.
Next Document:  Searching joint association signals in CATIE schizophrenia genome-wide association studies through a...