Status:
COMPLETED
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
Lead Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions:
Dysentery
Dysentery, Bacillary
Eligibility:
All Genders
3-5 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Health infants and children aged from 3 months to 5 years old.
- 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.
- Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
- Axillary temperature ≤37.0 ℃.
Exclusion
- Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
- Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
- Subject who are allergic to tetanus toxoid.
- Allergic history after vaccination.
- Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).
- Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.
- Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
- 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(Only applicable to 3-5 months old group).
- 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.
Key Trial Info
Start Date :
January 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT04865497
Start Date
January 19 2019
End Date
December 31 2020
Last Update
January 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quanzhou Center for Disease Control and Prevention
Quanzhou, Guangxi, China, 530000