Trials / Unknown
UnknownNCT06314659
Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months
A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 630 (actual)
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 3 Months – 5 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old.
Detailed description
This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. A total of 630 subjects were included and randomly assigned to the experimental group and control group in a 1:1 ratio.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu) | Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age. |
| BIOLOGICAL | Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) | Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months. |
| BIOLOGICAL | Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) | Performed booster immunization at 18 months of age. |
Timeline
- Start date
- 2021-09-17
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2024-03-18
- Last updated
- 2024-04-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06314659. Inclusion in this directory is not an endorsement.