A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults

NCT ID: NCT06354998

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2024-05-10

Brief Summary

To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational mRNA-1273.815

Participants will receive Investigational mRNA-1273.815 by intramuscular injection.

Group Type: EXPERIMENTAL

Investigational mRNA-1273.815

Intervention Type: BIOLOGICAL

Sterile solution for injection

Licensed Spikevax Vaccine

Participants will receive a licensed Spikevax vaccine by intramuscular injection.

Group Type: ACTIVE_COMPARATOR

Licensed Spikevax Vaccine

Intervention Type: BIOLOGICAL

Commercially available formulation

Interventions

Investigational mRNA-1273.815

Sterile solution for injection

Intervention Type: BIOLOGICAL

Licensed Spikevax Vaccine

Commercially available formulation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria:

1. Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1).

2. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1.

3. Has agreed to continue using an effective contraception through 2 weeks following injection.

4. Is not currently breastfeeding.

Exclusion Criteria

• Has known history of SARS-CoV-2 infection within 3 months prior to enrollment.
• Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator.
• Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
• Reported history of congenital or acquired immunodeficiency (for example, human immunodeficiency virus), immunosuppressive condition, asplenia, or recurrent severe infections disease.
• Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
• Receipt of the following:

1. COVID-19 vaccine within 3 months prior to enrollment

2. Any other licensed vaccine within 28 days before or 2 weeks after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.

3. Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Note: Inhaled, nasal, and topical steroids are allowed.

4. Systemic immunoglobulins or blood products within 3 months prior to Screening or plans for receipt during the study.

• Has donated ≥450 milliliters of blood products within 28 days prior to Screening or plans to donate blood products during the study.
• Has participated in an interventional clinical study within 28 days prior to Screening or plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Paratus Canberra

Canberra, Australian Capital Territory, Australia

Holdsworth House

Darlinghurst, New South Wales, Australia

Paratus Brisbane

Brisbane, Queensland, Australia

USC Morayfield

Morayfield, Queensland, Australia

University of the Sunshine Coast, South Bank

South Brisbane, Queensland, Australia

Emeritus Melbourne

Camberwell, Victoria, Australia

AusTrials Sunshine Hospital

Melbourne, Victoria, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mRNA-1273-P401

Identifier Type: -

Identifier Source: org_study_id