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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06354998




Registration number
NCT06354998
Ethics application status
Date submitted
5/04/2024
Date registered
9/04/2024
Date last updated
22/04/2024

Titles & IDs
Public title
A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
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
Secondary ID [1] 0 0
mRNA-1273-P401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Investigational mRNA-1273.815
Other interventions - 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.


Other interventions: Investigational mRNA-1273.815
Sterile solution for injection

Other interventions: Licensed Spikevax Vaccine
Commercially available formulation
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15
Timepoint [1] 0 0
Day 15
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
Timepoint [1] 0 0
Day 1 through Day 15
Secondary outcome [2] 0 0
Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15
Timepoint [2] 0 0
Day 15
Secondary outcome [3] 0 0
Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15
Timepoint [3] 0 0
Day 15

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Canberra - Canberra
Recruitment hospital [2] 0 0
Holdsworth House - Darlinghurst
Recruitment hospital [3] 0 0
Paratus Brisbane - Brisbane
Recruitment hospital [4] 0 0
USC Morayfield - Morayfield
Recruitment hospital [5] 0 0
University of the Sunshine Coast, South Bank - South Brisbane
Recruitment hospital [6] 0 0
Emeritus Melbourne - Camberwell
Recruitment hospital [7] 0 0
AusTrials Sunshine Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2617 - Canberra
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2617 - Brisbane
Recruitment postcode(s) [4] 0 0
4506 - Morayfield
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment postcode(s) [7] 0 0
3021 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ModernaTX, Inc.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06354998
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Moderna Clinical Trials Support Center
Address 0 0
Country 0 0
Phone 0 0
1-877-777-7187
Fax 0 0
Email 0 0
clinicaltrials@modernatx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06354998