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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04958954
Collaborator
(none)
50,000,000
1
23.8
2104944.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50000000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jul 7, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1: Pre-COVID

    All participants meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019

    Cohort 2: Active-COVID

    All participants meeting eligibility criteria in the Active-COVID-19 period, Pre-Emergency Use Authorization (EUA) period (following the emergence of COVID-19 but before the first COVID-19 vaccine EUA) (Time Period 2) from 01 December 2019 to 10 December 2020 (1 day prior to first United States SARS-CoV-2 vaccine EUA)

    Cohort 3: Post-EUA

    All mRNA-1273 vaccinated participants meeting eligibility criteria in the Post-EUA period (Time Period 3) from date of first United States SARS-CoV-2 vaccine EUA to 31 December 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aetion Inc. New York New York United States 10001

    Sponsors and Collaborators

    • ModernaTX, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ModernaTX, Inc.
    ClinicalTrials.gov Identifier:
    NCT04958954
    Other Study ID Numbers:
    • mRNA-1273-P903
    First Posted:
    Jul 12, 2021
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by ModernaTX, Inc.

    Study Results

    No Results Posted as of Dec 20, 2021