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

NCT06354998 | Completed Phase 3 Results FDA Drug

• 1 other identifier: mRNA-1273-P401
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 7

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

Keywords

mRNA-1273.815; mRNA-1273.815 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (1)

• Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15

  Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values reported greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 38 arbitrary unit (AU)/milliliter (mL) and ULOQ was 6960 AU/mL. 95% confidence interval (CI) of GM value was calculated based on the t-distribution of the log-transformed values for antibodies, then back transformed to the original scale for presentation.

  Day 15

Secondary Outcomes (2)

• Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study

  Day 1 through Day 15

• Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse

  Day 15

Study Arms (2)

Investigational mRNA-1273.815

EXPERIMENTAL

Participants will receive Investigational mRNA-1273.815 by intramuscular injection.

Biological: Investigational mRNA-1273.815

Licensed Spikevax Vaccine

ACTIVE COMPARATOR

Participants will receive a licensed Spikevax vaccine by intramuscular injection.

Biological: Licensed Spikevax Vaccine

Interventions

Investigational mRNA-1273.815 BIOLOGICAL

Sterile solution for injection

Investigational mRNA-1273.815

Licensed Spikevax Vaccine BIOLOGICAL

Commercially available formulation

Licensed Spikevax Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria:
• Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1).
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1.
• Has agreed to continue using an effective contraception through 2 weeks following injection.
• Is not currently breastfeeding.

You may not qualify if:

• 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:
• COVID-19 vaccine within 3 months prior to enrollment
• 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.
• 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.
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (7)

Paratus Canberra

Canberra, Australian Capital Territory, 2617, Australia

Location

Holdsworth House

Darlinghurst, New South Wales, 2010, Australia

Location

Paratus Brisbane

Brisbane, Queensland, 2617, Australia

Location

USC Morayfield

Morayfield, Queensland, 4506, Australia

Location

University of the Sunshine Coast, South Bank

South Brisbane, Queensland, 4101, Australia

Location

Emeritus Melbourne

Camberwell, Victoria, 3124, Australia

Location

AusTrials Sunshine Hospital

Melbourne, Victoria, 3021, Australia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 9, 2024
• Study Start: April 8, 2024
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)