Clinical Trials Logo
  1. Home
  2. SARS-CoV-2
  3. NCT04958954
  4. Details
NCT04958954 Clinical Trial

Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States

SARS-CoV-2 Clinical Trial

Official title:
Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04958954
Other study ID # mRNA-1273-P903
Secondary ID EUPAS41392
Status Completed
Phase
First received
Last updated
Start date July 7, 2021
Est. completion date June 30, 2023

Study information
Verified date July 2023
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.

Description:

This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.

Recruitment information / eligibility
Status Completed
Enrollment 50000000
Est. completion date June 30, 2023
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Included in a health plan covered by HealthVerity database - Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period. - Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered. Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Aetion Inc. New York New York

Sponsors (1)
Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events of Special Interests (AESIs) Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05584202 - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants Phase 2
Completed NCT04579549 - Repeat Testing for SARS-CoV-2 N/A
Active, not recruiting NCT05547243 - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China N/A
Recruiting NCT04747574 - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection Phase 1
Recruiting NCT04613310 - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) N/A
Terminated NCT04447404 - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury Phase 2
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Withdrawn NCT04388709 - Interferon Lambda Therapy for COVID-19 Phase 2
Active, not recruiting NCT05550142 - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China N/A
Completed NCT04620798 - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students N/A
Active, not recruiting NCT05547256 - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China N/A
Completed NCT04452604 - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed NCT04561102 - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed NCT05366322 - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated NCT04958304 - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A