NCT04865497

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysentery
• Dysentery, Bacillary

Interventions

Type	Name	Description
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.
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 adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
BIOLOGICAL	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.

Timeline

• Start date: 2019-01-19
• Primary completion: 2019-12-07
• Completion: 2020-12-31
• First posted: 2021-04-29
• Last updated: 2022-01-13

Locations

1 site across 1 country: China