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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
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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
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Secondary ID [1]
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mRNA-1010-P301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Seasonal Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
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Assessment method [1]
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Timepoint [1]
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Day 29
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Primary outcome [2]
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Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay
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Assessment method [2]
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Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer =1:40 or a pre-vaccination HAI titer =1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer.
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Timepoint [2]
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Day 29
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Primary outcome [3]
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Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
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Assessment method [3]
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Timepoint [3]
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Up to Day 7 (7 days after vaccination)
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Primary outcome [4]
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Number of Unsolicited Adverse Events (AEs)
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Assessment method [4]
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Timepoint [4]
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Up to Day 28 (28 days after vaccination)
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Primary outcome [5]
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Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
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Assessment method [5]
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Timepoint [5]
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Day 1 through Day 361
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Secondary outcome [1]
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Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI)
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Assessment method [1]
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A protocol-defined ILI is determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom (Body temperature >37.2 degrees celsius (°C) [> 99 degrees fahrenheit {°F}]; Chills; Tiredness; Headache; Myalgia; Nausea/vomiting; Diarrhea), or the occurrence of any 2 or more respiratory symptoms (Sore throat; Cough/rhinorrhea/nasal congestion [= 1 of the 3 symptoms count as 1 respiratory symptom]; Sputum production; Wheezing; Difficulty breathing). Protocol-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported.
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Timepoint [1]
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14 days post-vaccination through Day 181
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Secondary outcome [2]
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Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI
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Assessment method [2]
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A CDC-defined ILI is defined as body =37.8°C (100°F) accompanied by cough and/or sore throat. CDC-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported.
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Timepoint [2]
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14 days post-vaccination through Day 181
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Secondary outcome [3]
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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
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Assessment method [3]
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A protocol-defined ILI is determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom (Body temperature >37.2°C [> 99°F]; Chills; Tiredness; Headache; Myalgia; Nausea/vomiting; Diarrhea), or the occurrence of any 2 or more respiratory symptoms (Sore throat; Cough/rhinorrhea/nasal congestion [= 1 of the 3 symptoms count as 1 respiratory symptom]; Sputum production; Wheezing; Difficulty breathing). Protocol-defined ILI caused by any strain of influenza virus regardless of antigenic match to the strains selected for seasonal vaccine will be reported.
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Timepoint [3]
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14 days post-vaccination through Day 181
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Secondary outcome [4]
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Percentage of Participants With HAI Titer = 1:40 at Day 29
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Assessment method [4]
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Timepoint [4]
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Day 29
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Secondary outcome [5]
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Change From Baseline in Geometric Mean Fold Rise (GMFR) as Measured by HAI Assays
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Assessment method [5]
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Timepoint [5]
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Baseline, Up to Day 29
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/09/2023
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Sample size
Target
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Accrual to date
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Final
6102
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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PARC Clinical Research - Adelaide
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Recruitment hospital [2]
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Paratus Clinical Research - Brisbane Clinic - Albion
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Recruitment hospital [3]
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Paratus Clinical Research - Western Sydney - Blacktown
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Recruitment hospital [4]
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [5]
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Paratus Clinical Research - Canberra - Bruce
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Recruitment hospital [6]
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Emeritus Research - Camberwell
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Recruitment hospital [7]
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Monash Health, Monash Medical Centre - Clayton
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Recruitment hospital [8]
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Paratus Clinical Research - Central Coast - Kanwal
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Recruitment hospital [9]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [10]
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University of Melbourne - Parkville
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Recruitment hospital [11]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [12]
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Griffith University - Southport
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Recruitment hospital [13]
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AusTrials (Wellers Hill) - Tarragindi
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Recruitment hospital [14]
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CMAX - Woodville - Woodville
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Albion
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Recruitment postcode(s) [3]
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- Blacktown
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Recruitment postcode(s) [4]
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- Brookvale
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Recruitment postcode(s) [5]
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- Bruce
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Recruitment postcode(s) [6]
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- Camberwell
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Recruitment postcode(s) [7]
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- Clayton
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Recruitment postcode(s) [8]
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- Kanwal
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Recruitment postcode(s) [9]
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- Maroubra
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Recruitment postcode(s) [10]
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- Parkville
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Recruitment postcode(s) [11]
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- Sippy Downs
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Recruitment postcode(s) [12]
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- Southport
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Recruitment postcode(s) [13]
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- Tarragindi
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Recruitment postcode(s) [14]
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- Woodville
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Ciudad Autonoma Buenos Aires
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Country [3]
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Argentina
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State/province [3]
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Ciudad Autónoma Buenos Aires
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Country [4]
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Argentina
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State/province [4]
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Ciudad Autónoma de Buenos Aires
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Country [5]
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Argentina
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State/province [5]
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Ciudad De Cordoba
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Country [6]
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Argentina
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State/province [6]
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La Plata
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Country [7]
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Argentina
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State/province [7]
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Rosario
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Country [8]
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Argentina
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State/province [8]
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Río Cuarto
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Country [9]
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Argentina
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State/province [9]
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San Miguel de Tucumán
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Country [10]
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Colombia
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State/province [10]
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Acacías
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Country [11]
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Colombia
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State/province [11]
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Aguazul
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Country [12]
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Colombia
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State/province [12]
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Armenia
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Country [13]
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Colombia
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State/province [13]
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Barranquilla
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Country [14]
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Colombia
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State/province [14]
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Bogotá
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Colombia
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State/province [15]
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Chía
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Country [16]
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Colombia
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State/province [16]
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Floridablanca
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Colombia
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State/province [17]
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Girardot
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Colombia
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State/province [18]
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Ibague
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Colombia
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State/province [19]
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Medellín
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Colombia
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State/province [20]
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Santiago de Cali
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Country [21]
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Colombia
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State/province [21]
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Soledad
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Colombia
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State/province [22]
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Yopal
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Country [23]
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Panama
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State/province [23]
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Ciudad De Panamá
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Country [24]
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Panama
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State/province [24]
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Panamá
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Country [25]
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Philippines
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State/province [25]
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Iloilo City
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Country [26]
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Philippines
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State/province [26]
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Mandaluyong City
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Country [27]
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Philippines
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State/province [27]
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Manila City
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Country [28]
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Philippines
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State/province [28]
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Muntinlupa
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Country [29]
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Philippines
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State/province [29]
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Pasay
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Country [30]
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Philippines
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State/province [30]
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Quezon City
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ModernaTX, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05415462
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05415462
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