Trials / Unknown
UnknownNCT05156528
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21,000 (estimated)
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine | Single intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively. |
| BIOLOGICAL | Placebo | Single intramuscular dose contains 0.15\~0.25 mg of aluminum ion |
Timeline
- Start date
- 2021-12-11
- Primary completion
- 2024-01-11
- Completion
- 2024-01-11
- First posted
- 2021-12-14
- Last updated
- 2022-01-11
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05156528. Inclusion in this directory is not an endorsement.