Clinical Trials List
Protocol NumbermRNA-1083-P302
Completed
2024-12-01 - 2025-11-30
Phase III
Recruiting8
ICD-10J17
Pneumonia in diseases classified elsewhere
ICD-9484.8
Pneumonia in other infectious diseases classified elsewhere
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
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
ModernaTX, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ting-Shu Wu Division of Pediatrics
- 張冠民 Division of Pediatrics
- 謝顯森 Division of Pediatrics
- 吳秉宸 Division of Pediatrics
- 鄭鈞文 Division of Pediatrics
- 蔡依紋 Division of Pediatrics
- 方薇青 Division of Pediatrics
- WenJeng Lee Division of Pediatrics
- Horng-Chyuan Lin Division of Pediatrics
- Po-Yan Huang Division of Pediatrics
- Jau-Yuan Chen Division of Pediatrics
- 陳藝瑄 Division of Pediatrics
- 謝孟亨 Division of Pediatrics
- 盧美君 Division of Pediatrics
- YI-JU CHEN Division of Pediatrics
- 楊庭安 Division of Pediatrics
- 蘇弘濟 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂其融 Division of Infectious Disease
- 張雅婷 Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Tun-Chieh Chen Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
MING-CHE LIU
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
SARS‑CoV‑2 and Influenza
Objectives
To evaluate the humoral immune
responses of mRNA-1083 for
noninferiority relative to active
comparators for influenza and
SARS-CoV-2 at Day 29.
Test Drug
injection
Active Ingredient
mRNA-1083
Dosage Form
275
Dosage
NA
Endpoints
GM level at Day 29 by HAI assay for influenza virus
strains contained in mRNA-1083.
• GM level at Day 29 by PsVNA for SARS‑CoV‑2.
strains contained in mRNA-1083.
• GM level at Day 29 by PsVNA for SARS‑CoV‑2.
Inclution Criteria
Participants are eligible to be included in Part 1 of the study only if all of the following criteria
apply:
1. Medically stable adults ≥50 YOA, at the time of signing the informed consent
(Screening/Day 1 Visit).
Participants with chronic stable medical conditions with or without specific treatment,
such as diabetes mellitus, hypertension, cardiac disease, chronic lung disease, or
chronic renal disease are allowed to participate in this study if considered by the
Investigator as medically stable.
2. Investigator assessment that the participant understands and is willing and physically
able to comply with protocol-mandated follow-up, including all procedures.
3. Participants of nonchildbearing potential may be enrolled in the study.
Nonchildbearing potential is defined as postmenopausal or permanently sterilized as
described in Section 5.3 (Appendix 3). An FSH level may be measured at the
discretion of the Investigator to confirm postmenopausal status.
4. Participants who could become pregnant:
a. A participant who could become pregnant is eligible to participate if not pregnant or
breast/chestfeeding, and is using a contraceptive method that is highly effective (with
a failure rate of <1% per year), preferably with low user dependency, as described in
Section 5.3 (Appendix 3), 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. The Investigator should evaluate the potential for
contraceptive method failure (eg, noncompliance, recently initiated) in relationship to
the study intervention.
b. A POCBP must have a negative highly sensitive pregnancy test (urine) as required by
local regulations at Screening/Day 1 Visit, before the study intervention, see
Section 2.7.1.5.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
study participation if the serum pregnancy result is positive.
c. Additional requirements for pregnancy testing during and after study intervention are
located in Section 2.7.1.5.
d. The Investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a participant with an early
undetected pregnancy.
5. Male participants who have undergone a sterilization procedure are eligible to
participate in the study. 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.
PLUS, 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 POCBP partner use of an additional
highly effective contraceptive method with a failure rate of <1% per year, as
described in Section 5.3 (Appendix 3) when having sexual intercourse with a
POCBP who is not currently pregnant.
− Agree to use an external condom when engaging in any activity that allows for
passage of ejaculate to another person.
6. Capable of giving signed informed consent as described in Section 5.1.3, which
includes compliance with the requirements and restrictions listed in the ICF and in the
protocol.
7. Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days
prior to Day 1.
apply:
1. Medically stable adults ≥50 YOA, at the time of signing the informed consent
(Screening/Day 1 Visit).
Participants with chronic stable medical conditions with or without specific treatment,
such as diabetes mellitus, hypertension, cardiac disease, chronic lung disease, or
chronic renal disease are allowed to participate in this study if considered by the
Investigator as medically stable.
2. Investigator assessment that the participant understands and is willing and physically
able to comply with protocol-mandated follow-up, including all procedures.
3. Participants of nonchildbearing potential may be enrolled in the study.
Nonchildbearing potential is defined as postmenopausal or permanently sterilized as
described in Section 5.3 (Appendix 3). An FSH level may be measured at the
discretion of the Investigator to confirm postmenopausal status.
4. Participants who could become pregnant:
a. A participant who could become pregnant is eligible to participate if not pregnant or
breast/chestfeeding, and is using a contraceptive method that is highly effective (with
a failure rate of <1% per year), preferably with low user dependency, as described in
Section 5.3 (Appendix 3), 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. The Investigator should evaluate the potential for
contraceptive method failure (eg, noncompliance, recently initiated) in relationship to
the study intervention.
b. A POCBP must have a negative highly sensitive pregnancy test (urine) as required by
local regulations at Screening/Day 1 Visit, before the study intervention, see
Section 2.7.1.5.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
study participation if the serum pregnancy result is positive.
c. Additional requirements for pregnancy testing during and after study intervention are
located in Section 2.7.1.5.
d. The Investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a participant with an early
undetected pregnancy.
5. Male participants who have undergone a sterilization procedure are eligible to
participate in the study. 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.
PLUS, 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 POCBP partner use of an additional
highly effective contraceptive method with a failure rate of <1% per year, as
described in Section 5.3 (Appendix 3) when having sexual intercourse with a
POCBP who is not currently pregnant.
− Agree to use an external condom when engaging in any activity that allows for
passage of ejaculate to another person.
6. Capable of giving signed informed consent as described in Section 5.1.3, which
includes compliance with the requirements and restrictions listed in the ICF and in the
protocol.
7. Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days
prior to Day 1.
Exclusion Criteria
Participants are excluded from Part 1 of the study if any of the following criteria apply:
1. 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.
Clinically unstable is defined as a diagnosis or condition requiring changes in
management or medication ≤60 days prior to Screening and includes ongoing workup
of an undiagnosed illness that could lead to a new diagnosis or condition.
Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies
used to treat them (eg, immunosuppressive treatments), at the discretion of the
Investigator.
2. Undergone surgical procedures within 14 days prior to Day 1 or are scheduled to
undergo a surgical procedure within 28 days after study injection are also excluded.
However, minor surgical procedures under local anesthesia (eg, excision of skin
lesion) or diagnostic procedures (eg, colonoscopy) are allowed.
3. Reported history of congenital or acquired immunodeficiency (eg, HIV),
immunosuppressive condition, asplenia, or recurrent severe infections.
Certain immune‑mediated conditions that are stable and well‑controlled (eg,
Hashimoto thyroiditis) as well as those that do not require systemic
immunosuppressants per Exclusion Criterion 14 (eg, psoriasis or vitiligo), may be
permitted at the discretion of the Investigator.
4. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos,
psoriasis patches affecting skin over the deltoid injection site areas).
5. 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.
6. History of coagulopathy, bleeding disorder, or other condition that is considered a
contraindication to IM injection, subcutaneous injection, or phlebotomy.
7. History of malignancy within the previous 2 years (excluding nonmelanoma skin
cancer).
8. Any medical, psychiatric, or occupational condition, including a 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.
9. History of myocarditis or pericarditis within 90 days prior to the Screening
Visit/Day 1. Participants who have not returned to the Day 1 (Baseline) clinical status
after their convalescent period will also be excluded.
10. History of Guillain-Barré syndrome.
11. Known history of SARS‑CoV‑2 infection within 150 days prior to Day 1.
1. 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.
Clinically unstable is defined as a diagnosis or condition requiring changes in
management or medication ≤60 days prior to Screening and includes ongoing workup
of an undiagnosed illness that could lead to a new diagnosis or condition.
Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies
used to treat them (eg, immunosuppressive treatments), at the discretion of the
Investigator.
2. Undergone surgical procedures within 14 days prior to Day 1 or are scheduled to
undergo a surgical procedure within 28 days after study injection are also excluded.
However, minor surgical procedures under local anesthesia (eg, excision of skin
lesion) or diagnostic procedures (eg, colonoscopy) are allowed.
3. Reported history of congenital or acquired immunodeficiency (eg, HIV),
immunosuppressive condition, asplenia, or recurrent severe infections.
Certain immune‑mediated conditions that are stable and well‑controlled (eg,
Hashimoto thyroiditis) as well as those that do not require systemic
immunosuppressants per Exclusion Criterion 14 (eg, psoriasis or vitiligo), may be
permitted at the discretion of the Investigator.
4. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos,
psoriasis patches affecting skin over the deltoid injection site areas).
5. 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.
6. History of coagulopathy, bleeding disorder, or other condition that is considered a
contraindication to IM injection, subcutaneous injection, or phlebotomy.
7. History of malignancy within the previous 2 years (excluding nonmelanoma skin
cancer).
8. Any medical, psychiatric, or occupational condition, including a 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.
9. History of myocarditis or pericarditis within 90 days prior to the Screening
Visit/Day 1. Participants who have not returned to the Day 1 (Baseline) clinical status
after their convalescent period will also be excluded.
10. History of Guillain-Barré syndrome.
11. Known history of SARS‑CoV‑2 infection within 150 days prior to Day 1.
The Estimated Number of Participants
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Taiwan
150 participants
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Global
2450 participants
