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NCT05894499
Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19
trial in SARS-CoV-2 in 13,309 participants. Completed in 26 May 2023.
26 May 2023
Quick facts
| Lead sponsor | ModernaTX, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 13,309 |
| Start date | 15 November 2022 |
| Primary completion | 26 May 2023 |
| Estimated completion | 26 May 2023 |
| Sites | 1 location across Japan |
Conditions studied
- SARS-CoV-2 — all drugs for SARS-CoV-2 →
Sponsor
ModernaTX, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05894499
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other ModernaTX, Inc. trials
Trials by the same sponsor.
- NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
- NCT07478952 — A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age · Phase 1 · recruiting
- NCT07266558 — A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without Hig · Phase 4 · recruiting
- NCT07116616 — A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 1, PHASE2 · recruiting
- NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05894499 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ModernaTX, Inc.
- Last refreshed: 15 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05894499.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing