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

Phase 2

Completed

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

• Registration Number: NCT04865497
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-15
• Study Start: 2019-01-19
• Primary Completion: 2019-12-07
• Study Completion: 2020-12-31
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant-free Group	Haemophilus b Conjugate Vaccine	Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
High dose Group	Haemophilus b Conjugate Vaccine	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Low dose Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Low dose Group	Haemophilus b Conjugate Vaccine	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Control Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	Haemophilus b Conjugate Vaccine,10μg/dose
High dose Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Adjuvant-free Group	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine	Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose

Primary Outcome Measures

Name	Time	Method
incidence of adverse events during 30 days	30 day after each vaccination	Occurrence of adverse events during a 30 day follow-up period after each vaccination
Antibody positive rate	30 day after each vaccination	Percentage of participants with seroresponse to each vaccination

Trial Locations

Locations (1)

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