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Sequential Enhanced Safety Study of a Novel Coronavirus Messenger RNA (mRNA) Vaccine in Adults Aged 18 Years and Older.

NCT05568693 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2022-10-06

No results posted yet for this study

Summary

This trial is a clinical study to evaluate the safety of sequential boosters of novel coronavirus mRNA vaccine in adults aged 18 years and older who have completed three doses of novel inactivated coronavirus vaccination. According to the results of the previous phase I clinical trial, the incidence of adverse reactions in the 0.3 ml dose group was lower than that in the 0.5 ml dose group, and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study, and a 1-dose immunization program was completed for safety observation.

Conditions

  • Corona Virus Disease 2019(COVID-19)

Interventions

BIOLOGICAL

0.3ml of mRNA vaccine

Subjects received 0.3ml of mRNA vaccine intramuscularly

Sponsors & Collaborators

  • Yu Qin

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2022-10-15
Completion
2023-03-21

Countries

  • China

Study Locations

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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 NCT05568693 on ClinicalTrials.gov