Clinical trial NCT06694389: Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age
Official title: A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Influenza
Keywords: Influenza
COVID-19
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 2457
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).


Eligibility criteria: Key Inclusion Criteria:

* Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1 Visit).
* A participant who could become pregnant is eligible to participate if the following is met:

  * Not pregnant or breast/chestfeeding, and is using a contraceptive method that is highly effective for at least 90 days after the study intervention administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
  * Have a negative highly sensitive pregnancy test (urine) as required by local regulations at Screening/Day 1 Visit, before the study intervention.
* Participants who can produce sperm are eligible to participate if they agree to the following for at least 90 days after the study intervention administration:

  * Refrain from donating sperm.
  * Either be abstinent from reproductive sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use an external condom with a person who could become pregnant partner use of an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse.
* Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
* Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior to Day 1

Key Exclusion Criteria:

* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* 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.
* Known history of SARS-CoV-2 infection within 150 days prior to Day 1.
* Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. Inhaled nasal and topical steroids are allowed.
* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
* Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
* Received a seasonal influenza vaccine ≤150 days prior to Day 1.
* Treated with antiviral therapies for influenza (for example, Tamiflu®) ≤150 days prior to Day 1.
* 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 5 days prior to Day 1
* 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.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit/Day 1 or plans to donate blood products during the study.
* 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.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
timeFrame: Day 29
measure: GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
timeFrame: Day 29
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Day 1 through 7 days after study injection
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Day 1 through 28 days after study injection
measure: Number of Participants With Medically Attended Adverse Events (MAAEs)
timeFrame: Day 1 though Day 181
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 though Day 181
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 181
measure: Number of Participants With AEs Leading to Discontinuation
timeFrame: Day 1 through Day 181
Secondary outcomes:
measure: Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay
timeFrame: Day 29
measure: SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA
timeFrame: Day 29
measure: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
timeFrame: Day 1, Day 29
measure: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
timeFrame: Day 1, Day 29
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Public Health Association.Inc.
state: Aichi
city: Nagoya-shi
country: Japan
facility: Daido Clinic
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Tenjin Sogo Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: PS Clinic - Internal medicine
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka Heartnet Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Motomachi Takatsuka Naika Clinic - Internal Medicine
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Nishi-Kumamoto Hospital
state: Kumamoto
city: Osaki-shi
country: Japan
facility: Sato Hospital
state: Miyagi
city: Mino
country: Japan
facility: Yokoi Medicine Clinic
state: Osaka
city: Adachi-ku
country: Japan
facility: Shinwakai Adachi Kyosai Hospital - Internal Medicine
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Dojinkinenkai Meiwa Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo center clinic - Internal medicine
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Asbo Tokyo Asbo Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: New Medical Research System Clinic
state: Tokyo
city: Nerima
country: Japan
facility: Shimamura Memorial Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Denenchofu Family Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Hillside Clinic Jingumae
state: Tokyo
city: Shinjuku
country: Japan
facility: Clinical Research Tokyo Hospital - Clinical Research Center
state: Tokyo
city: Shinjuku
country: Japan
facility: Higashi-Shinjuku Clinic - Internal Medicine
state: Tokyo
city: Suginami
country: Japan
facility: Shinei Medical Healthcare Clinic
state: Tokyo
city: Sumida-Ku
country: Japan
facility: Souseikai Sumida Hospital
state: Tokyo
city: Taito-ku
country: Japan
facility: Seishukai Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Metropolitan Clinic - Internal Medicine
state: Tokyo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital - Infectious Diseases
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital - Allergology
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital - Dajia
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University - Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital - Neihu Branch - Infectious Diseases
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Study officials:
References: