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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.
According to the results of the preliminary phase I clinical trial, the incidence of adverse reactions in subjects in the 0.3 ml dose group was lower than 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.
The trial was designed to enroll 800 adult subjects aged 18 years and older who had completed three doses of inactivated New Coronavirus vaccine with an interval of more than 6 months between doses, and the proportion of elderly people aged 60 years and older was approximately 20%. Subjects will receive 0.3 ml of mRNA vaccine, complete a 1-dose immunization program, and undergo safety observations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-enhanced immunoem | Experimental | 1 dose of 0.3 ml of mRNA vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3ml of mRNA vaccine | Biological | Subjects received 0.3ml of mRNA vaccine intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days of exemption | Incidence of adverse reaction (AR) | 28 days post vaccination |
| Evaluation of the incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) in all subjects at 6 months after exemption | Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) | 6 months post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the incidence of adverse reactions in all subjects at 30 minutes post-dispensing | Incidence of adverse reaction (AR) | 30 minutes post vaccination |
| Evaluation of the incidence of adverse events in all subjects within 28 days of exemption |
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Inclusion Criteria:
Subjects have completed 3 doses of inactivated vaccine with at least 6 months between the last dose.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Chengdu | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| ID | Term |
|---|---|
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
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Incidence of adverse events (AE)
| 28 days post vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |