Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

Phase 1

Completed

• Conditions: Dysentery; Dysentery, Bacillary
• Interventions: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine

• Registration Number: NCT03561181
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-18
• Primary Completion: 2018-01-28
• Study Completion: 2018-02-08
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
High dose Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination

Trial Locations

Locations (1)

Yizhou Center for Disease Control and Prevention; 🇨🇳 Yizhou, Guangxi, China