Trials / Unknown
UnknownNCT04466085
Clinical Study of Recombinant Novel Coronavirus Vaccine
A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 900 (actual)
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
Summary
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Detailed description
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases. Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant new coronavirus vaccine (CHO cell) low-dose group | Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
| BIOLOGICAL | Recombinant new coronavirus vaccine (CHO cells) high-dose group | Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
| BIOLOGICAL | Recombinant new coronavirus vaccine (CHO cells) placebo group | Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
Timeline
- Start date
- 2020-07-12
- Primary completion
- 2020-10-22
- Completion
- 2021-12-15
- First posted
- 2020-07-10
- Last updated
- 2020-12-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04466085. Inclusion in this directory is not an endorsement.