Influenza Clinical Trial
Official title:
A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
Verified date | December 2023 |
Source | ModernaTX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
Status | Completed |
Enrollment | 270 |
Est. completion date | December 19, 2023 |
Est. primary completion date | December 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | 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 assigned females at birth and 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. Exclusion Criteria: - Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1. - Participant is acutely ill or febrile (temperature =38.0?elcius [100.4°Fahrenheit]) 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. - 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 congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections. - Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. - Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein. - Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing. - Participant has received any vaccine authorized or approved by local health agency =28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing. - Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1. - Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1. - Participant is not aware whether they have received an influenza vaccine in the prior 12 months. - Participant has donated =450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study. |
Country | Name | City | State |
---|---|---|---|
United States | United Medical Associates | Binghamton | New York |
United States | Meridian Clinical Research | Hastings | Nebraska |
United States | CenExel RCA | Hollywood | Florida |
United States | Johnson County Clin-Trials | Lenexa | Kansas |
United States | Meridian Clinical Research | Lincoln | Nebraska |
United States | Suncoast Research Group | Miami | Florida |
United States | Rockville Internal Medicine | Rockville | Maryland |
United States | DM Clinical Research | Southfield | Michigan |
United States | DM Clinical Research | Sugar Land | Texas |
United States | Texas Center for Drug Development | Tomball | Texas |
Lead Sponsor | Collaborator |
---|---|
ModernaTX, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 7 (7 days after vaccination) | ||
Primary | Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 29 (28 days after vaccination) | ||
Primary | Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation | Day 1 through Day 181 | ||
Secondary | Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay | Baseline, Day 181 | ||
Secondary | Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay | Baseline, Day 181 | ||
Secondary | Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay | Seroresponse is defined as an increase of antibody titers and concentrations from predose below the prespecified lower limit of quantification. | Day 181 |
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 |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and 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 |