The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,050
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Quanzhou Center for Disease Control and Prevention
Quanzhou, Guangxi, China
incidence of adverse events during 30 days
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time frame: 30 day after each vaccination
Antibody positive rate
Percentage of participants with seroresponse to each vaccination
Time frame: 30 day after each vaccination
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Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.