A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
- Conditions
- Seasonal Influenza
- Interventions
- Biological: Fluarix Tetra
- Registration Number
- NCT05415462
- Lead Sponsor
- ModernaTX, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6102
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1010 mRNA-1010 Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Fluarix Tetra Fluarix Tetra Participants will receive a single dose of Fluarix Tetra by IM injection on Day 1.
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Day 29 Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Day 29 Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Seroconversion was defined as either a Baseline HAI titer \<1:10 and a post-Baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-Baseline HAI Ab titer.Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) 7 days post-vaccination Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Number of Participants With Unsolicited AEs Up to 28 days post-vaccination An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation Day 1 through Day 361 (Month 12) An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 \[COVID-19\] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.
- Secondary Outcome Measures
Name Time Method Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus 14 days post-vaccination through Day 181 (Month 6) A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2 degrees Celsius (°C) (\>99 degrees Fahrenheit \[°F\]), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.
Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Strain of Influenza Virus 14 days post-vaccination through Day 181 (Month 6) A CDC-defined ILI was defined as body temperature ≥37.8°C (100°F) accompanied by cough and/or sore throat.
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Any Strain of Influenza Virus in Participants Aged 50 Years and Older or 65 Years and Older 14 days post-vaccination through Day 181 (Month 6) A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2°C (\>99°F), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Day 29 Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Baseline, Day 29 The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Trial Locations
- Locations (53)
Expertia S.A- Mautalen Salud e Investigacion
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Argentina
Emeritus Research
🇦🇺Camberwell, Australia
Monash Health, Monash Medical Centre
🇦🇺Clayton, Australia
Griffith University
🇦🇺Southport, Australia
AusTrials (Wellers Hill)
🇦🇺Tarragindi, Australia
Consultorios Médicos Dr. Doreski
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Sanatorio Allende S.A.
🇦🇷Ciudad De Cordoba, Argentina
PARC Clinical Research
🇦🇺Adelaide, Australia
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Paratus Clinical Research - Western Sydney
🇦🇺Blacktown, Australia
Fundación Socolinsky Centro de Vacunación Proteger
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Argentina
Clínica Universitaria Bolivariana
🇨🇴Medellín, Colombia
Paratus Clinical Research - Brisbane Clinic
🇦🇺Albion, Australia
CMAX - Woodville
🇦🇺Woodville, Australia
CEI -Centro de Estudios Infectológicos
🇦🇷Buenos Aires, Argentina
AES - AS - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L. ("CLINICA MAYO") Tucumán
🇦🇷San Miguel de Tucumán, Argentina
Paratus Clinical Research - Central Coast
🇦🇺Kanwal, Australia
Caja de Compensacion Familiar CAFAM sede Centro de atención en salud CAFAM Floresta
🇨🇴Bogotá, Colombia
University of the Sunshine Coast
🇦🇺Sippy Downs, Australia
Paratus Clinical Research - Canberra
🇦🇺Bruce, Australia
University of Melbourne
🇦🇺Parkville, Australia
Australian Clinical Research Network
🇦🇺Maroubra, Australia
Clinica de la Costa Ltda - PPDS
🇨🇴Barranquilla, Colombia
Manila Doctors Hospital
🇵🇭Manila City, Philippines
Instituto Medico Platense
🇦🇷La Plata, Argentina
Swiss Medical Center Barrio Parque
🇦🇷Ciudad Autónoma Buenos Aires, Argentina
Northern Beaches Clinical Research
🇦🇺Brookvale, Australia
Fundacion Oftalmologica de Santander Foscal
🇨🇴Floridablanca, Colombia
CEVAXIN 24 de diciembre
🇵🇦Panamá, Panama
Lung Center of The Philippines
🇵🇭Quezon City, Philippines
Centro de Atención e Investigación Médica S.A. - CAIMED - Acacías
🇨🇴Acacías, Colombia
Unidad Integral de Endocrinologia
🇨🇴Bogotá, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Yopal
🇨🇴Yopal, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Armenia
🇨🇴Armenia, Colombia
CEVAXIN Avenida México
🇵🇦Panamá, Panama
West Visayas State University Medical Center
🇵🇭Iloilo City, Philippines
Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
🇨🇴Bogotá, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
🇨🇴Chía, Colombia
AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medelin
🇨🇴Medellín, Colombia
Centro de Estudios en Infectología Pediatrica S.A.S - PPDS
🇨🇴Santiago de Cali, Colombia
Fundación Hospital Universidad del Norte
🇨🇴Soledad, Colombia
Medical Center Manila
🇵🇭Manila City, Philippines
Asian Hospital and Medical Center
🇵🇭Muntinlupa, Philippines
San Juan de Dios Hospital
🇵🇭Pasay, Philippines
Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
🇨🇴Aguazul, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
🇨🇴Girardot, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
🇨🇴Ibague, Colombia
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
🇵🇦Ciudad De Panamá, Panama
Healthlink Iloil
🇵🇭Iloilo City, Philippines
St. Paul's Hospital
🇵🇭Iloilo City, Philippines
Health Cube Medical Clinics
🇵🇭Mandaluyong City, Philippines