A Study of the Effectiveness of Moderna COVID-19 Vaccine

NCT05933304 | Completed

• 1 other identifier: mRNA-1273-P901
• Study Type: observational
• Target: 927,004
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of Participants With SARS-CoV-2 Infection

  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.

  Up to 3 years

• Number of Participants With Severe COVID-19 Disease

  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).

  Up to 3 years

Study Arms (2)

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).

Unexposed Cohort

Participants in this cohort include: * Participants who had not received any bivalent dose but had received at least 2 doses of monovalent mRNA COVID-19 vaccine by the index date * Participants who never received any COVID-19 vaccine dose by the index date 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).

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants vaccinated with Moderna COVID-19 vaccine and unvaccinated participants are included in this study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 6, 2023
• Study Start: December 18, 2020
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

US (1)