Clinical trial NCT04865497: Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
Official title: A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysentery
Dysentery, Bacillary
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 1050
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: incidence of adverse events during 30 days
timeFrame: 30 day after each vaccination
measure: Antibody positive rate
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: Quanzhou Center for Disease Control and Prevention
state: Guangxi
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Du lin, Master
role: STUDY_CHAIR
References:
citation: Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines (Basel). 2021 Dec 28;10(1):33. doi: 10.3390/vaccines10010033.