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

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.

Study Overview

• Status: Completed
• Conditions: Dysentery, Bacillary; Dysentery
• Intervention / Treatment: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Yizhou, Guangxi, China, 546300
      • Yizhou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose Group; Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; 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.; Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Experimental: low dose Group; Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; 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.; Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Investigators: Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): January 28, 2018
• Study Completion (Actual): February 8, 2018

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Dysentery, Bacillary; Dysentery; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 201619306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No