Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
Pizhou City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40%
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time frame: day 28 after dose 2
Number of participants with Adverse Reactions (ARs)
Frequency and severity of ARs for 28 days after each vaccination
Time frame: 28 days after each vaccination
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Time frame: day 28 after dose 2
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain
Time frame: day 28 after dose 2
Number of participants with Adverse Events (AEs)
Frequency and severity of AEs for 28 days after each vaccination
Time frame: 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Frequency of SAEs for 6 months after the last vaccination
Time frame: 6 months after the last vaccination
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