To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against theOmicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).
Not Provided
Biological: Investigational mRNA-1273.815
Sterile solution for injection
Biological: Licensed Spikevax Vaccine
Commercially available formulation
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.
Note: Other inclusion and exclusion criteria may apply.
Paratus Canberra
Canberra 2172517, Australian Capital Territory 2177478, Australia
Holdsworth House
Darlinghurst 2169378, New South Wales 2155400, Australia
Paratus Brisbane
Brisbane 2174003, Queensland 2152274, Australia
USC Morayfield
Morayfield 2156934, Queensland 2152274, Australia
University of the Sunshine Coast, South Bank
South Brisbane 2207259, Queensland 2152274, Australia
Emeritus Melbourne
Camberwell 2172686, Victoria 2145234, Australia
AusTrials Sunshine Hospital
Melbourne 2158177, Victoria 2145234, Australia
Not Provided