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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/NCT05415462




Registration number
NCT05415462
Ethics application status
Date submitted
8/06/2022
Date registered
13/06/2022
Date last updated
13/09/2023

Titles & IDs
Public title
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Scientific title
A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
Secondary ID [1] 0 0
mRNA-1010-P301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - mRNA-1010
Other interventions - Licensed quadrivalent inactivated seasonal influenza vaccine

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

Active Comparator: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine - Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.


Other interventions: mRNA-1010
Sterile liquid for injection

Other interventions: Licensed quadrivalent inactivated seasonal influenza vaccine
Sterile suspension for injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Timepoint [1] 0 0
Day 29
Primary outcome [2] 0 0
Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay
Timepoint [2] 0 0
Day 29
Primary outcome [3] 0 0
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Timepoint [3] 0 0
Up to Day 7 (7 days after vaccination)
Primary outcome [4] 0 0
Number of Unsolicited Adverse Events (AEs)
Timepoint [4] 0 0
Up to Day 28 (28 days after vaccination)
Primary outcome [5] 0 0
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Timepoint [5] 0 0
Day 1 through Day 361
Secondary outcome [1] 0 0
Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI)
Timepoint [1] 0 0
14 days post-vaccination through Day 181
Secondary outcome [2] 0 0
Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI
Timepoint [2] 0 0
14 days post-vaccination through Day 181
Secondary outcome [3] 0 0
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI in Participants Aged 50 Years and Older or 65 Years and Older
Timepoint [3] 0 0
14 days post-vaccination through Day 181
Secondary outcome [4] 0 0
Percentage of Participants With HAI Titer = 1:40 at Day 29
Timepoint [4] 0 0
Day 29
Secondary outcome [5] 0 0
Change From Baseline in Geometric Mean Fold Rise (GMFR) as Measured by HAI Assays
Timepoint [5] 0 0
Baseline, Up to Day 29

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

- 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, and agreement to continue adequate contraception
through 90 days following vaccine administration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as
defined by the United States (US) CDC or has had a positive SARS-CoV-2 test in the
past 10 days prior to the Screening Visit.

- Participant is acutely ill or febrile (temperature =38.0? [100.4°F]) 72 hours prior to
or at the Screening Visit or Day 1. Participants meeting this criterion may be
rescheduled within the 28-day screening window and will retain their initially
assigned participant number.

- Participant has a history of a diagnosis or condition that, in the judgment of the
investigator, is clinically unstable or may affect participant safety, assessment of
safety endpoints, assessment of immune response, or adherence to study procedures.

- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of
any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines,
including egg protein.

- Participant has received systemic immunosuppressants or immune-modifying drugs for >14
days in total within 180 days prior to the Screening Visit (for corticosteroids, =10
mg/day of prednisone or equivalent) or is anticipating the need for systemic
immunosuppressive treatment at any time during participation in the study. Inhaled,
nasal, and topical steroids are allowed.

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

- Participant is not aware whether they have received an influenza vaccine in the past
12 months or has received a seasonal influenza vaccine or any other investigational
influenza vaccine within 180 days prior to Day 1.

- Participant has tested positive for influenza by local health authority-approved
testing methods within 180 days prior to the Screening Visit.

- Participant has donated =450 milliliters (mL) of blood products within 28 days prior
to 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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/09/2023
Sample size
Target
Accrual to date
Final
6102
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
PARC Clinical Research - Adelaide
Recruitment hospital [2] 0 0
Paratus Clinical Research - Brisbane Clinic - Albion
Recruitment hospital [3] 0 0
Paratus Clinical Research - Western Sydney - Blacktown
Recruitment hospital [4] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [5] 0 0
Paratus Clinical Research - Canberra - Bruce
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment hospital [7] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Paratus Clinical Research - Central Coast - Kanwal
Recruitment hospital [9] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [10] 0 0
University of Melbourne - Parkville
Recruitment hospital [11] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [12] 0 0
Griffith University - Southport
Recruitment hospital [13] 0 0
AusTrials (Wellers Hill) - Tarragindi
Recruitment hospital [14] 0 0
CMAX - Woodville - Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Albion
Recruitment postcode(s) [3] 0 0
- Blacktown
Recruitment postcode(s) [4] 0 0
- Brookvale
Recruitment postcode(s) [5] 0 0
- Bruce
Recruitment postcode(s) [6] 0 0
- Camberwell
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Kanwal
Recruitment postcode(s) [9] 0 0
- Maroubra
Recruitment postcode(s) [10] 0 0
- Parkville
Recruitment postcode(s) [11] 0 0
- Sippy Downs
Recruitment postcode(s) [12] 0 0
- Southport
Recruitment postcode(s) [13] 0 0
- Tarragindi
Recruitment postcode(s) [14] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autónoma Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autónoma de Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad De Cordoba
Country [6] 0 0
Argentina
State/province [6] 0 0
La Plata
Country [7] 0 0
Argentina
State/province [7] 0 0
Rosario
Country [8] 0 0
Argentina
State/province [8] 0 0
Río Cuarto
Country [9] 0 0
Argentina
State/province [9] 0 0
San Miguel de Tucumán
Country [10] 0 0
Colombia
State/province [10] 0 0
Acacías
Country [11] 0 0
Colombia
State/province [11] 0 0
Aguazul
Country [12] 0 0
Colombia
State/province [12] 0 0
Armenia
Country [13] 0 0
Colombia
State/province [13] 0 0
Barranquilla
Country [14] 0 0
Colombia
State/province [14] 0 0
Bogotá
Country [15] 0 0
Colombia
State/province [15] 0 0
Chía
Country [16] 0 0
Colombia
State/province [16] 0 0
Floridablanca
Country [17] 0 0
Colombia
State/province [17] 0 0
Girardot
Country [18] 0 0
Colombia
State/province [18] 0 0
Ibague
Country [19] 0 0
Colombia
State/province [19] 0 0
Medellín
Country [20] 0 0
Colombia
State/province [20] 0 0
Santiago de Cali
Country [21] 0 0
Colombia
State/province [21] 0 0
Soledad
Country [22] 0 0
Colombia
State/province [22] 0 0
Yopal
Country [23] 0 0
Panama
State/province [23] 0 0
Ciudad De Panamá
Country [24] 0 0
Panama
State/province [24] 0 0
Panamá
Country [25] 0 0
Philippines
State/province [25] 0 0
Iloilo City
Country [26] 0 0
Philippines
State/province [26] 0 0
Mandaluyong City
Country [27] 0 0
Philippines
State/province [27] 0 0
Manila City
Country [28] 0 0
Philippines
State/province [28] 0 0
Muntinlupa
Country [29] 0 0
Philippines
State/province [29] 0 0
Pasay
Country [30] 0 0
Philippines
State/province [30] 0 0
Quezon City

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010
relative to that of an active comparator against vaccine-matched influenza A and B strains at
Day 29, and to evaluate the safety and reactogenicity of mRNA-1010.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05415462
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