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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/NCT05585632




Registration number
NCT05585632
Ethics application status
Date submitted
14/10/2022
Date registered
19/10/2022
Date last updated
8/03/2024

Titles & IDs
Public title
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old
Scientific title
Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age
Secondary ID [1] 0 0
2022-002138-15
Secondary ID [2] 0 0
mRNA-1230-P101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 0 0
Influenza 0 0
RSV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - mRNA-1010
Other interventions - mRNA-1345
Other interventions - mRNA-1273.214
Other interventions - mRNA-1045
Other interventions - mRNA-1230

Experimental: mRNA-1010 - Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Experimental: mRNA-1345 - Participants will receive a dose of mRNA-1345 by IM injection on Day 1.

Experimental: mRNA-1273.214 - Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.

Experimental: mRNA-1045 Dose Level A - Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.

Experimental: mRNA-1045 Dose Level B - Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.

Experimental: mRNA-1045 Dose Level C - Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.

Experimental: mRNA-1230 Dose Level A - Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.

Experimental: mRNA-1230 Dose Level B - Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.

Experimental: mRNA-1230 Dose Level C - Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.


Other interventions: mRNA-1010
Sterile liquid for injection

Other interventions: mRNA-1345
Sterile liquid for injection

Other interventions: mRNA-1273.214
Sterile liquid for injection

Other interventions: mRNA-1045
Formulation for injection

Other interventions: mRNA-1230
Formulation for injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timepoint [1] 0 0
Up to Day 8 (7 days post vaccination)
Primary outcome [2] 0 0
Number of Participants with Unsolicited Adverse Events (AEs)
Timepoint [2] 0 0
Up to Day 29 (28 days post vaccination)
Primary outcome [3] 0 0
Number of Participants with Medically-Attended AEs (MAAEs)
Timepoint [3] 0 0
Day 1 through Day 361
Primary outcome [4] 0 0
Number of Participants with Adverse Events of Special Interest (AESIs)
Timepoint [4] 0 0
Day 1 through Day 361
Primary outcome [5] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Day 1 through Day 361
Primary outcome [6] 0 0
Number of Participants with AEs Leading to Discontinuation
Timepoint [6] 0 0
Day 1 through Day 361
Secondary outcome [1] 0 0
Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Timepoint [1] 0 0
Baseline (Day 1), Day 29
Secondary outcome [2] 0 0
Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29
Timepoint [2] 0 0
Baseline (Day 1), Day 29
Secondary outcome [3] 0 0
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
Timepoint [3] 0 0
Baseline (Day 1), Day 29
Secondary outcome [4] 0 0
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Timepoint [4] 0 0
Baseline (Day 1), Day 29
Secondary outcome [5] 0 0
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Timepoint [5] 0 0
Baseline (Day 1), Day 29
Secondary outcome [6] 0 0
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
Timepoint [6] 0 0
Baseline (Day 1), Day 29
Secondary outcome [7] 0 0
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Timepoint [7] 0 0
Baseline (Day 1) to Day 29
Secondary outcome [8] 0 0
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
Timepoint [8] 0 0
Baseline (Day 1) to Day 29
Secondary outcome [9] 0 0
RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay
Timepoint [9] 0 0
Baseline (Day 1) to Day 29

Eligibility
Key inclusion criteria
- Investigator assessment that participant understands and is willing and physically
able to comply with protocol-mandated follow-up, including all procedures.

- Body mass index of 18 to 35 kilograms/square meter (kg/m^2) (inclusive) at the
Screening Visit(s).

- For female participants of childbearing potential: negative pregnancy test, adequate
contraception or has abstained from all activities that could result in pregnancy for
at least 28 days prior to Day 1, agreement to continue adequate contraception or
abstinence through 3 months following the vaccination, and not currently
breastfeeding.

- Fully vaccinated for COVID-19 with an approved primary series according to the locally
authorized or approved regimen. The most recent COVID-19 vaccine (primary series or
booster) must be =120 days before (or less per local guidance) Day 1.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Acutely ill or febrile (temperature =38.0°Celsius/[100.4°Fahrenheit]) 72 hours before
or at the Screening Visit or Day 1. Participants meeting this criterion may be
rescheduled within the 28-day screening window for re-evaluation and will retain their
initially assigned participant number.

- Any medical, psychiatric, or occupational condition, including reported history of
drug or alcohol abuse, that, in the opinion of the investigator, might pose additional
risk due to participation in the study or could interfere with the interpretation of
study results.

- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
total within 6 months before screening (for corticosteroids =10 milligrams (mg)/day of
prednisone or equivalent) or is anticipating the need for immunosuppressive treatment
at any time during participation in the study.

- Received or plans to receive any vaccine authorized or approved by a local health
agency =28 days before study injections (Day 1) or within 28 days after the study
injection.

- Received a licensed seasonal influenza vaccine or any other investigational influenza
or RSV vaccine within =180 days before Day 1.

- Tested positive for influenza or RSV by local health authority-approved testing
methods within =180 days before Day 1.

- Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14
days, as defined by the United States Center for Disease Control (CDC) or the European
Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19
case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.

- Donated =450 mL of blood products within 28 days before the Screening Visit or plans
to donate blood products during the 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2024
Sample size
Target
Accrual to date
Final
392
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Kanwal - Kanwal
Recruitment hospital [3] 0 0
Paratus Clinical Research Brisbane - Albion
Recruitment hospital [4] 0 0
Nucleus Network Brisbane Clinic - Centre For Clinical Studies - Herston
Recruitment hospital [5] 0 0
University of the Sunshine Coast - South Brisbane
Recruitment hospital [6] 0 0
AusTrials Taringa - Taringa
Recruitment hospital [7] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
4010 - Albion
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
QLD 4068 - Taringa
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United Kingdom
State/province [8] 0 0
England
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Nottinghamshire
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Oxfordshire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bristol
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Exeter
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary goal of this study is to evaluate the safety and reactogenicity of
multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and
SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214
(SARS-CoV-2) vaccines in healthy older participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05585632
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries