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A Study of the Effectiveness of Moderna COVID-19 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05933304
Recruitment Status : Active, not recruiting
First Posted : July 6, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:

This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC).

The primary objective of this study is to evaluate the vaccine effectiveness (VE) of receipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severe COVID-19 disease.

SARS-CoV-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a COVID-19 diagnosis code. Severe COVID-19 disease will be defined as COVID-19 hospitalization or mortality.


Condition or disease
SARS-CoV-2 COVID-19

Detailed Description:

This study utilized electronic healthcare data collected within the Kaiser Permanente Southern California (KPSC) integrated healthcare system which provides care to over 4.6 million individuals. Participants in this study received vaccination and were assessed for study outcomes as part of routine care. Vaccination information and study outcome status was assessed using procedure, diagnostic, and laboratory code information. Medical chart review was conducted to assess the association of severe outcomes (hospitalization and death) with COVID-19 illness.

Analyses assessing absolute vaccine effectiveness will identify participants who receive Moderna COVID vaccine from the KPSC electronic healthcare database and match them to unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination (index date). Vaccinated and unvaccinated participants will then be followed-up in the database for the occurrence of study outcomes. Cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.

Analyses of relative vaccine effectiveness will identify participants who receive specific dose number and formulation of Moderna COVID vaccine (Group N) from the KPSC electronic healthcare database and match them to a group of vaccinated participants with a different dose/formulation type (i.e. Group n-1). Similar matching criteria will be applied. Both groups will be followed for study outcomes and cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : April 14, 2025
Estimated Study Completion Date : April 14, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Vaccinated Cohort
Participants who receive Moderna COVID-19 vaccine during a pre-specified time frame and meet eligibility criteria will be included in this cohort. Participants will be followed up through Electronic Health Record (EHR) for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine).
Unvaccinated Cohort
Participants who have not received Moderna COVID-19 vaccine or any other COVID-19 vaccine as of the index date of their matched vaccinated participant and who meet eligibility criteria will be included in this cohort. Participants will be followed up through EHR for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine).


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With SARS-CoV-2 Infection [ Time Frame: Up to 3 years ]
    SARS-CoV-2 infection is defined as a positive antigen test result as well as a positive molecular test or a COVID-19 diagnosis code.

  2. Number of Participants With Severe COVID-19 Disease [ Time Frame: Up to 3 years ]
    Severe COVID-19 disease includes COVID-19 hospitalization (hospitalization with a SARS-CoV-2 positive test or a COVID-19 diagnosis, or a hospitalization occurring ≤7 days after a SARS-CoV-2 positive test, with chart review to confirm severe COVID-19 symptoms) and COVID-19 mortality (death during COVID-19 hospitalization).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants vaccinated with Moderna COVID-19 vaccine and unvaccinated participants are included in this study.
Criteria

Inclusion Criteria:

  • Aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after Food and Drug Administration [FDA] authorization to vaccinate younger age groups)
  • KPSC member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap)

Exclusion Criteria:

  • Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the index date
  • Receipt of 2 doses of Moderna COVID-19 vaccine <24 days apart for 2-dose exposed cohort
  • Receipt of any COVID-19 vaccine <14 days after the index date
  • No health care utilization and no vaccination from the 2 years prior to the index date through the index date
  • Occurrence of a COVID-19 outcome <14 days after the index date
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933304


Locations
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United States, California
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05933304    
Other Study ID Numbers: mRNA-1273-P901
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases