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

Dysentery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561181
• Other study ID #: 201619306
• Status: Completed
• Phase: Phase 1
• Start date: July 18, 2017
• Est. completion date: February 8, 2018

Study information

• Verified date: October 2018
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 8, 2018
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysentery
• Dysentery, Bacillary

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Yizhou Center for Disease Control and Prevention	Yizhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events during a 30 day follow-up period after each vaccination		30 day after each vaccination