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

NCT03561181 | Completed Phase 1

• 1 other identifier: 201619306
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysentery; Dysentery, Bacillary

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events during a 30 day follow-up period after each vaccination

  30 day after each vaccination

Study Arms (2)

High dose Group

EXPERIMENTAL

Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose

Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine

low dose Group

EXPERIMENTAL

Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose

Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine

Interventions

S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine BIOLOGICAL

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.

High dose Group

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Yizhou Center for Disease Control and Prevention

Yizhou, Guangxi, 546300, China

Location

MeSH Terms

Conditions

Dysentery; Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Du lin, Master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: July 18, 2017
• Primary Completion: January 28, 2018
• Study Completion: February 8, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)