title: A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people.
abstract: To evaluate the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine, 3308 healthy Chinese people more than 3 years old were enrolled in a randomized, controlled, blinded study and divided into four age groups: 3-10 years, 11-17 years, 18-54 years, and more than 55 years. Each age group was then randomized (2:1) to receive either influenza vaccine or control vaccine (recombinant hepatitis B) for one dose. Also each influenza vaccine group was randomized (1:1:1) to receive three different batches of influenza vaccine. Systematic and local adverse reactions for 28 days after vaccination were recorded, and influenza antibody titer was determined by hemagglutination inhibition (HI) assay at 28 days after vaccination. There were significant differences in seroconversion and seroprotection rates achieved post-immunization of three strains of influenza antibody (H1N1, H3N2, B) between experimental group and control group in all age groups (P<0.05). In addition, there were no statistically significant differences in local and systematic reaction rates after vaccination between the experimental and control group in all age groups (P>0.05), except for the systematic reaction rates in the 18-54 years and ≥ 55 years age groups (P<0.05). Thus, Aleph inactivated split influenza vaccine has good safety and immunogenicity.
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Shuming
authors.initials: S
authors.lastname: Li
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Xing
authors.initials: X
authors.lastname: Ai
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Liqing
authors.initials: L
authors.lastname: Yang
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Yunhua
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Zhaoyun
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Xiaohongmen Hospital; Beijing, PR China.
authors.forename: Huixia
authors.initials: H
authors.lastname: Han
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Lu
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Fengji
authors.initials: F
authors.lastname: Luo
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Dongba Hospital; Beijing, PR China.
authors.forename: Chunyu
authors.initials: C
authors.lastname: Liu
authors.affiliation: Zuojiazhuang Hospital; Beijing, PR China.
authors.forename: Jun
authors.initials: J
authors.lastname: Xiao
authors.affiliation: Chaoyang Diseases Control and Prevention Center; Beijing, PR China.
authors.forename: Nianmin
authors.initials: N
authors.lastname: Shi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: batch consistency; immunogenicity; inactivated split influenza vaccine; safety