SARS-CoV-2Phase 3NCT06354998
A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
A Phase 3 study testing Investigational mRNA-1273.815 and Licensed Spikevax Vaccine in people with SARS-CoV-2, run by ModernaTX, Inc. at 7 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Investigational mRNA-1273.815 and Licensed Spikevax Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 7 sitesAustralia
- Study dates
- 8 Apr 2024to 10 May 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Paratus Brisbane
Brisbane, Queensland, 2617
Emeritus Melbourne
Camberwell, Victoria, 3124
Paratus Canberra
Canberra, Australian Capital Territory, 2617
Holdsworth House
Darlinghurst, New South Wales, 2010
AusTrials Sunshine Hospital
Melbourne, Victoria, 3021
USC Morayfield
Morayfield, Queensland, 4506
University of the Sunshine Coast, South Bank
South Brisbane, Queensland, 4101
About this study
Official title: Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
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
- Being tested
- Investigational mRNA-1273.815, Licensed Spikevax Vaccine
- Keywords
- mRNA-1273.815, mRNA-1273.815 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational mRNA-1273.815Biological
Sterile solution for injection
Licensed Spikevax VaccineBiological
Commercially available formulation
| Study group | Role | What they receive |
|---|---|---|
| Investigational mRNA-1273.815 | Experimental | Participants will receive Investigational mRNA-1273.815 by intramuscular injection. Receives: Biological: Investigational mRNA-1273.815 |
| Licensed Spikevax Vaccine | Active comparator | Participants will receive a licensed Spikevax vaccine by intramuscular injection. Receives: Biological: Licensed Spikevax Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. Number of participants with SAEs, AESIs, and AEs leading to discontinuation up to Day 15 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Measured: Day 1 through Day 15
Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse
Seroresponse at a participant level was defined as a change from baseline below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if baseline was equal to or above the LLOQ. LLOQ was 38 AU/mL.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start8 Apr 2024
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354998
- Sponsor's protocol ID
- mRNA-1273-P401
- Status last verified
- May 2025
- First submitted
- 5 Apr 2024
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
- ClinicalTrials.gov ID
- NCT06354998
- Acronym / sponsor ID
- mRNA-1273-P401
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational mRNA-1273.815 | Experimental | Biological: Investigational mRNA-1273.815Participants will receive Investigational mRNA-1273.815 by intramuscular injection. |
| Licensed Spikevax Vaccine | Active comparator | Biological: Licensed Spikevax VaccineParticipants will receive a licensed Spikevax vaccine by intramuscular injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational mRNA-1273.815Sterile solution for injection | Biological | Investigational mRNA-1273.815 |
| Licensed Spikevax VaccineCommercially available formulation | Biological | Licensed Spikevax Vaccine |
Primary outcome
Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
Time frame: 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.
2 secondary outcomes
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study
Time frame: Day 1 through Day 15
Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational mRNA-1273.815 and Licensed Spikevax Vaccine in people with SARS-CoV-2, run by ModernaTX, Inc. at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.