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.

Trial registration: ClinicalTrials.gov NCT01758185.

Keywords: batch consistency; immunogenicity; inactivated split influenza vaccine; safety.

Figures

Figure 1. Study outline. Number in bracket is the number of drop-outs.