Immunogenicity and Safety Study of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adultsin China

NCT04954131 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 766

Last updated 2022-03-10

No results posted yet for this study

Summary

The purpose of this clinical study, CLO-SCB-2019-010, is to assess the immunogenicity, reactogenicity and safety of the SCB-2019 vaccine in Chinese participants, and to show the comparability of the immune response versus randomly selected individuals who participated in the large-scale efficacy study with the SCB-2019 vaccine (Study CLO-SCB-2019-003).

Conditions

Interventions

BIOLOGICAL

Candidate Vaccine, SCB-2019

30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants

OTHER

Placebo

Saline solution (0.9%)

Sponsors & Collaborators

  • Zhejiang Clover Biopharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2021-11-15
Completion
2022-11-15

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954131 on ClinicalTrials.gov