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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05606965




Registration number
NCT05606965
Ethics application status
Date submitted
31/10/2022
Date registered
7/11/2022
Date last updated
1/10/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults
Scientific title
Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults
Secondary ID [1] 0 0
mRNA-CRID-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - mRNA-1010
Treatment: Other - Egg-based Quadrivalent Influenza Vaccine
Treatment: Other - Adjuvanted Quadrivalent Influenza Vaccine
Treatment: Other - Inactivated Influenza Vaccine

Experimental: mRNA-1010 (Age Group 18-50 years) - Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Active comparator: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years) - Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Active comparator: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years) - Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Active comparator: Inactivated Influenza Vaccine (Age Group 65-80 years) - Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.

Experimental: mRNA-1010 (Age Group 65-80 years) - Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.


Treatment: Other: mRNA-1010
Sterile liquid for injection

Treatment: Other: Egg-based Quadrivalent Influenza Vaccine
Sterile suspension for injection

Treatment: Other: Adjuvanted Quadrivalent Influenza Vaccine
Sterile injectable emulsion

Treatment: Other: Inactivated Influenza Vaccine
Sterile suspension for injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Timepoint [1] 0 0
Up to Day 7 (7 days after vaccination)
Primary outcome [2] 0 0
Number of Unsolicited Adverse Events (AEs)
Timepoint [2] 0 0
Up to Day 28 (28 days after vaccination)
Primary outcome [3] 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 [3] 0 0
Day 1 through Day 181
Primary outcome [4] 0 0
Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
Timepoint [4] 0 0
Baseline, Day 29
Primary outcome [5] 0 0
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Timepoint [5] 0 0
Baseline, Day 29
Primary outcome [6] 0 0
Percentage of Participants with Seroresponse, as Measured by HAI Assay
Timepoint [6] 0 0
Day 29
Secondary outcome [1] 0 0
Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay
Timepoint [1] 0 0
Baseline, Days 121 and 181
Secondary outcome [2] 0 0
Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay
Timepoint [2] 0 0
Baseline, Days 121 and 181

Eligibility
Key inclusion criteria
* Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the screening visit. There will be no BMI requirement for inclusion in Part B.
* Female participants of childbearing potential: has a negative pregnancy test on the day of vaccination (D1); practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days before D1; has agreed to continue adequate contraception through 3 months after vaccine administration; and is not currently breastfeeding.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Acutely ill or febrile (temperature = 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
* Any medical, psychiatric, or occupational condition, including reported history of substance 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.
* Reported history of congenital or acquired immunodeficiency, immunocompromising or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
* Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
* Has received systemic immunosuppressants (for glucocorticoids = 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
* Has a 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.

Other protocol-defined inclusion/exclusion criteria 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
Trial website
https://clinicaltrials.gov/study/NCT05606965
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05606965