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A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.

NCT05354089 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-24

No results posted yet for this study

Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.

Conditions

Interventions

BIOLOGICAL

20 μg dose of SYS6006

20 μg dose of SYS6006 vaccine IM on day 0 and day 21.

BIOLOGICAL

30 μg dose of SYS6006

30 μg dose of SYS6006 vaccine IM on day 0 and day 21.

DRUG

Placebo

Placebo IM on day 0 and day 21.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lanjuan Li · Shulan (Hangzhou) Hospital

  • Guiling Chen · Shulan (Hangzhou) Hospital

  • Xiang Lu · Sir Run Run Hosipital Nanjing Medical University

  • Yuwen Su · Sir Run Run Hosipital Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-07-09
Completion
2023-10-01

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT05354089 on ClinicalTrials.gov