Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

Dysentery Clinical Trial

Official title:

A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial to Evaluate Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged From 3 Months to 5 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865497
• Other study ID #: 201820301
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• 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 immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: December 31, 2020
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:

• Health infants and children aged from 3 months to 5 years old.
• 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.
• Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
• Axillary temperature =37.0 ?.

Exclusion Criteria:

• Febrile illness (temperature = 38°C) in the 3 days or in the acute phase of the disease / active period.
• Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
• Subject who are allergic to tetanus toxoid.
• Allergic history after vaccination.
• Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (=14 days).
• Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.
• Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
• 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(Only applicable to 3-5 months old group).
• 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.
• 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 adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
• Haemophilus b Conjugate Vaccine
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (1)

Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines. 2022; 10(1):33.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events during 30 days	Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination
Primary	Antibody positive rate	Percentage of participants with seroresponse to each vaccination	30 day after each vaccination