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A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

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ClinicalTrials.gov Identifier: NCT05827926
Recruitment Status : Active, not recruiting
First Posted : April 25, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
The purpose of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Influenza Biological: Fluarix Biological: mRNA-1083.1 Biological: mRNA-1083.2 Biological: mRNA-1083.3 Biological: mRNA-1010.4 Biological: mRNA-1283.222 Biological: mRNA-1273.222 Biological: mRNA-1010 Biological: Fluzone HD Phase 1 Phase 2

Detailed Description:
Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to <80 years of age or Cohort B for adults ≥18 to <65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to <50 years and ≥50 to <65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults
Actual Study Start Date : April 14, 2023
Estimated Primary Completion Date : December 20, 2023
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A2: mRNA-1083.1 Dose B
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
 Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Cohort A3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
 Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Cohort A4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort A5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort A6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort A7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
 Biological: mRNA-1083.3
Sterile liquid for injection
Active Comparator: Cohort A8: mRNA-1010.4
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
 Biological: mRNA-1010.4
Sterile liquid for injection
Active Comparator: Cohort A9: mRNA-1283.222
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
 Biological: mRNA-1283.222
Sterile liquid for injection
Active Comparator: Cohort A10: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
 Biological: mRNA-1273.222
Sterile liquid for injection
Active Comparator: Cohort A11: mRNA-1010
Participants will receive single IM injection of mRNA-1010 on Day 1.
 Biological: mRNA-1010
Sterile liquid for injection
Active Comparator: Cohort A12: Fluarix
Participants will receive single IM injection of Fluarix on Day 1.
 Biological: Fluarix
quadrivalent seasonal influenza vaccine
Active Comparator: Cohort A13: Fluzone HD
Participants will receive single IM injection of Fluzone HD on Day 1.
 Biological: Fluzone HD
quadrivalent seasonal influenza vaccine
Experimental: Cohort B1: mRNA-1083.1 Dose A
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
 Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Cohort B2: mRNA-1083.1 Dose B
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
 Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Cohort B3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
 Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Cohort B4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort B5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort B6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
 Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Cohort B7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
 Biological: mRNA-1083.3
Sterile liquid for injection
Active Comparator: Cohort B8: mRNA-1010.4
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
 Biological: mRNA-1010.4
Sterile liquid for injection
Active Comparator: Cohort B9: mRNA-1283.222
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
 Biological: mRNA-1283.222
Sterile liquid for injection
Active Comparator: Cohort B10: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
 Biological: mRNA-1273.222
Sterile liquid for injection
Active Comparator: Cohort B11: mRNA-1010
Participants will receive single IM injection of mRNA-1010 on Day 1.
 Biological: mRNA-1010
Sterile liquid for injection
Active Comparator: Cohort B12: Fluarix
Participants will receive single IM injection of Fluarix on Day 1.
 Biological: Fluarix
quadrivalent seasonal influenza vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days after vaccination) ]
  2. Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs [ Time Frame: Up to Day 28 (28 days after vaccination) ]
  3. Number of Participants With Unsocilited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study [ Time Frame: Day 1 through Day 181 ]

Secondary Outcome Measures :
  1. Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Baseline (Day 1), Day 29, and Day 181 ]
  2. Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [ Time Frame: Baseline (Day 1), Day 29, and Day 181 ]
  3. Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [ Time Frame: Baseline (Day 1), Day 29, and Day 181 ]
  4. Change From Baseline in GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [ Time Frame: Baseline (Day 1), Day 29, and Day 181 ]
  5. Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay [ Time Frame: Baseline (Day 1) to Day 29, and Day 181 ]
    Seroconversion is defined as a Day 29 and Day 181 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.

  6. SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA [ Time Frame: Baseline (Day 1) to Day 29, and Day 181 ]
    Seroresponse is defined as a Day 29 and Day 181 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) titers measured by PsVNA.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Body mass index (BMI) of 18 kilograms (kg)/m2 to 35 kg/square meter (m^2) (inclusive) at the Screening Visit.
  • Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
  • 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 through 90 days following vaccine administration, and not currently breastfeeding.
  • Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1.

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • 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 clinical trial or could interfere with the interpretation of study results.
  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
  • Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
  • Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
  • 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 clinical trial.

Note: Other inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05827926


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05827926    
Other Study ID Numbers: mRNA-1083-P101
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1083
mRNA-1083 Vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
 Virus Diseases
Messenger RNA
Influenza Vaccine
Moderna
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases