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
- Conditions
- COVID-19Influenza
- Interventions
- Biological: Licensed Influenza VaccineOther: Placebo
- Registration Number
- NCT06694389
- Lead Sponsor
- ModernaTX, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2450
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Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1 Visit).
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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.
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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.
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Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
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Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior to Day 1
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1083 and Placebo mRNA-1083 Participants 50 years of age and older will receive mRNA-1083 by intramuscular (IM) injection and placebo by subcutaneous (SC) or IM injection administered on Day 1. mRNA-1083 and Placebo Placebo Participants 50 years of age and older will receive mRNA-1083 by intramuscular (IM) injection and placebo by subcutaneous (SC) or IM injection administered on Day 1. Licensed influenza vaccine + SARS-CoV-2 vaccine Licensed Influenza Vaccine Participants of age 50 years and older will receive licensed influenza vaccine by SC or IM injection and SARS-CoV-2 vaccine by IM injection administered on Day 1. Licensed influenza vaccine + SARS-CoV-2 vaccine SARS-CoV-2 Vaccine Participants of age 50 years and older will receive licensed influenza vaccine by SC or IM injection and SARS-CoV-2 vaccine by IM injection administered on Day 1.
- Primary Outcome Measures
Name Time Method Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay Day 29 GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) Day 29 Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Day 1 through 7 days after study injection Number of Participants With Unsolicited Adverse Events (AEs) Day 1 through 28 days after study injection Number of Participants With Medically Attended Adverse Events (MAAEs) Day 1 though Day 181 Number of Participants With Adverse Events of Special Interest (AESIs) Day 1 though Day 181 Number of Participants With Serious Adverse Events (SAEs) Day 1 through Day 181 Number of Participants With AEs Leading to Discontinuation Day 1 through Day 181
- Secondary Outcome Measures
Name Time Method Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay Day 29 Seroconversion is defined as a Day 29 post-injection level ≥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.
SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA Day 29 Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay Day 1, Day 29 GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA Day 1, Day 29
Trial Locations
- Locations (45)
Fukuoka Heartnet Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical
🇯🇵Sapporo-shi, Hokkaido, Japan
Motomachi Takatsuka Naika Clinic - Internal Medicine
🇯🇵Yokohama-shi, Kanagawa, Japan
Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Nishi-Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Sato Hospital
🇯🇵Osaki-shi, Miyagi, Japan
Yokoi Medicine Clinic
🇯🇵Mino, Osaka, Japan
Shinwakai Adachi Kyosai Hospital - Internal Medicine
🇯🇵Adachi-ku, Tokyo, Japan
Dojinkinenkai Meiwa Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Nihonbashi Sakura Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo center clinic - Internal medicine
🇯🇵Chuo-ku, Tokyo, Japan
Medical Corporation Asbo Tokyo Asbo Clinic
🇯🇵Chuo-ku, Tokyo, Japan
New Medical Research System Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
Shimamura Memorial Hospital
🇯🇵Nerima, Tokyo, Japan
Denenchofu Family Clinic
🇯🇵Ota-ku, Tokyo, Japan
Shinei Medical Healthcare Clinic
🇯🇵Suginami, Tokyo, Japan
Hillside Clinic Jingumae
🇯🇵Shibuya-ku, Tokyo, Japan
Clinical Research Tokyo Hospital - Clinical Research Center
🇯🇵Shinjuku, Tokyo, Japan
Higashi-Shinjuku Clinic - Internal Medicine
🇯🇵Shinjuku, Tokyo, Japan
Souseikai Sumida Hospital
🇯🇵Sumida-Ku, Tokyo, Japan
Seishukai Clinic
🇯🇵Taito-ku, Tokyo, Japan
Metropolitan Clinic - Internal Medicine
🇯🇵Toshima-ku, Tokyo, Japan
Korea University Ansan Hospital
🇰🇷Ansan-si, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Kaohsiung Medical University - Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Kuang Tien General Hospital - Dajia
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Medical University - Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital - Neihu Branch - Infectious Diseases
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Kyungpook National University Hospital - Infectious Diseases
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital - Allergology
🇰🇷Gwangju, Korea, Republic of
Public Health Association.Inc.
🇯🇵Nagoya-shi, Aichi, Japan
Daido Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Tenjin Sogo Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
PS Clinic - Internal medicine
🇯🇵Fukuoka-shi, Fukuoka, Japan