Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06354998
Registration number
NCT06354998
Ethics application status
Date submitted
5/04/2024
Date registered
9/04/2024
Date last updated
25/05/2025
Titles & IDs
Public title
A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
mRNA-1273-P401
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Investigational mRNA-1273.815
Treatment: Other - Licensed Spikevax Vaccine
Experimental: Investigational mRNA-1273.815 - Participants will receive Investigational mRNA-1273.815 by intramuscular injection.
Active comparator: Licensed Spikevax Vaccine - Participants will receive a licensed Spikevax vaccine by intramuscular injection.
Treatment: Other: Investigational mRNA-1273.815
Sterile solution for injection
Treatment: Other: Licensed Spikevax Vaccine
Commercially available formulation
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Geometric Mean (GM) Value of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 15
Query!
Secondary outcome [1]
0
0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 1 through Day 15
Query!
Secondary outcome [2]
0
0
Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain: Percentage of Participants With Seroresponse
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Day 15
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key 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.
Note: Other inclusion and exclusion criteria may apply.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/04/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/05/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
217
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Paratus Canberra - Canberra
Query!
Recruitment hospital [2]
0
0
Holdsworth House - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Paratus Brisbane - Brisbane
Query!
Recruitment hospital [4]
0
0
USC Morayfield - Morayfield
Query!
Recruitment hospital [5]
0
0
University of the Sunshine Coast, South Bank - South Brisbane
Query!
Recruitment hospital [6]
0
0
Emeritus Melbourne - Camberwell
Query!
Recruitment hospital [7]
0
0
AusTrials Sunshine Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2617 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
2617 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
4506 - Morayfield
Query!
Recruitment postcode(s) [5]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [6]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [7]
0
0
3021 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
ModernaTX, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT06354998
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Moderna Clinical Trials Support Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-777-7187
Query!
Fax
0
0
Query!
Email
0
0
clinicaltrials@modernatx.com
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/98/NCT06354998/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/98/NCT06354998/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT06354998
Download to PDF