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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04958954

Enrollment

50000000

Registered

2021-07-12

Start date

2021-07-07

Completion date

2023-06-30

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2

Keywords

mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Outcome results