Dysentery, Dysentery, Bacillary
Conditions
Brief summary
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
Interventions
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.
Sponsors
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 3 months old and above healthy people. * Subject or legal representative who consent and has signed written informed consent. * Subject and parent/guardian who is able to comply with all study procedures. * Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. * Axillary temperature ≤37.0 ℃.
Exclusion criteria
* Febrile illness (temperature ≥ 38°C) in the 3 days. * Subject who are allergic to tetanus toxoid. * Allergic history after vaccination. * Immunodeficiency diseases patients who administered with immunosuppressive agents. * In pregnancy or lactation or pregnant women. * Subject who are suffering from serious chronic diseases, infectious diseases, active infection, cardiovascular disease,liver or kidney disease. * Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days. * History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease. * Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication. * Children with abnormal labor（pregnancy week\<37w,\>42w）,birth weight (\<2500g,\>4000g), asphyxia rescue history,congenital malformations or developmental disorders(Only applicable to 3-5 months old group) * Blood routine, blood chemistry and urinalysis laboratory collection abnormalities and the severity of grade 2 and above before immunization. * Subject who plan to participate in or is in any other drug clinical trial. * Any condition that, in the judgment of investigator, may affect trial assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |
Countries
China
Outcome results
None listed