Clinical trial NCT05156528: Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dysentery
Shigellosis
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 21000
Sex: ALL
Minimum age (years): 6
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 the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.


Eligibility criteria: Inclusion Criteria:

* Infants and children aged from 3 months to 5 years old;
* The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
* The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
* Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
* Axillary temperature ≤37.0℃;
* According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition.

Exclusion Criteria:

* Previous proven history of bacillary dysentery;
* Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
* Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
* Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
* With pathological jaundice confirmed by existing diagnosis;
* History of thrombocytopenia or other coagulation disorders with definite diagnosis;
* Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
* Received immunoglobulin / blood products treatment within 3 months before vaccination;
* Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
* Subjects with the following diseases:

  1. Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
  2. Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
  3. Severe asthma;
  4. Systemic rash, dermatophyte, skin suppuration or blister;
  5. History or family history of convulsion, epilepsy, encephalopathy, mental illness;
* Planning to participate or currently participating in clinical trials of other vaccines or drugs;
* Any situation that the investigator believed may affect the study evaluation.

Primary outcomes:
measure: Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Hezhou
country: China
facility: Hezhou Center for Disease Control and Prevention
state: Guangxi
city: Luzhai
country: China
facility: Luzhai Center for Disease Control and Prevention
state: Guangxi
city: Sanjiang
country: China
facility: Sanjiang Center for Disease Control and Prevention
state: Guangxi
city: Zhongshan
country: China
facility: Zhongshan Center for Disease Control and Prevention
state: Guangxi
city: Handan
country: China
facility: Yongnian Center for Disease Control and Prevention
state: Hebei
city: Yuanshi
country: China
facility: Yuanshi Center for Disease Control and Prevention
state: Hebei
city: Panzhihua
country: China
facility: Panzhihua Center for Disease Control and Prevention
state: Sichuan
city: Zigong
country: China
facility: Zigong Center for Disease Control and Prevention
state: Sichuan
city: Zigong
country: China
facility: Fushun Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Lin Du
role: STUDY_CHAIR
References: