Influenza Clinical Trial
Official 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
Verified date | March 2024 |
Source | ModernaTX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 392 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | 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. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Paratus Clinical Research Brisbane | Albion | Queensland |
Australia | Paratus Clinical Research Western Sydney | Blacktown | New South Wales |
Australia | Emeritus Research | Camberwell | Victoria |
Australia | Nucleus Network Brisbane Clinic - Centre For Clinical Studies | Herston | Queensland |
Australia | Paratus Clinical Kanwal | Kanwal | New South Wales |
Australia | University of the Sunshine Coast | South Brisbane | Queensland |
Australia | AusTrials Taringa | Taringa | Queensland |
United Kingdom | Bristol Royal Hospital for Children | Bristol | |
United Kingdom | Royal Devon & Exeter Hospital | Exeter | |
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | National Hospital for Neurology and Neurosurgery | London | |
United Kingdom | St George's Healthcare NHS Trust - University of London - Th | London | |
United Kingdom | Newcastle University - Institute of Cellular Medicine (ICM) | Newcastle | England |
United Kingdom | Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus | Nottingham | Nottinghamshire |
United Kingdom | University of Oxford | Oxford | Oxfordshire |
United Kingdom | Southampton General Hospital | Southampton | |
United States | Velocity Clinical Research | Anderson | South Carolina |
United States | Atlanta Center for Medical Research - Family Medicine | Atlanta | Georgia |
United States | Centricity Research | Columbus | Georgia |
United States | Cenexel IRA (iResearch Atlanta) | Decatur | Georgia |
United States | Accel Research Sites | DeLand | Florida |
United States | Research Centers of America (cenexel) | Hollywood | Florida |
United States | DM Clinical Research | Houston | Texas |
United States | Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) | Morehead City | North Carolina |
United States | Trial Management Associates | Myrtle Beach | South Carolina |
United States | Optimal Research | Peoria | Illinois |
United States | Accel Research Sites | Saint Petersburg | Florida |
United States | DM Clinical Research | Southfield | Michigan |
United States | DM Clinical Research | Sugar Land | Texas |
United States | Trial Management Associates | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
ModernaTX, Inc. |
United States, Australia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 8 (7 days post vaccination) | ||
Primary | Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 29 (28 days post vaccination) | ||
Primary | Number of Participants with Medically-Attended AEs (MAAEs) | Day 1 through Day 361 | ||
Primary | Number of Participants with Adverse Events of Special Interest (AESIs) | Day 1 through Day 361 | ||
Primary | Number of Participants with Serious Adverse Events (SAEs) | Day 1 through Day 361 | ||
Primary | Number of Participants with AEs Leading to Discontinuation | Day 1 through Day 361 | ||
Secondary | Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29 | Baseline (Day 1), Day 29 | ||
Secondary | Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay | Seroconversion is defined as a Day 29 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. | Baseline (Day 1) to Day 29 | |
Secondary | SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay) | Seroresponse is defined as a Day 29 titer =4-fold if baseline is =lower limit of quantification (LLOQ) or =4*LLOQ if baseline titer is Baseline (Day 1) to Day 29 |
| |
Secondary | RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay | Seroresponse is defined as a Day 29 titer =4-fold if baseline is =LLOQ or =4*LLOQ if baseline titer is Baseline (Day 1) to Day 29 |
| |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |