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The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1189 Dose Level 1 (ID) | Experimental | Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
|
| mRNA-1189 Dose Level 2 (ID) | Experimental | Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
|
| mRNA-1189 Dose Level 1 (IM) | Experimental | Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
|
| mRNA-1189 Dose Level 2 (IM) | Experimental | Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1189 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 64 (7-day follow-up after vaccination) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 85 (28-day follow-up after vaccination) | |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | Day 1 up to Day 225 | |
| Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs) | Day 1 to end of study (EOS) (Day 225) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb) | Days 1 and 85 | |
| Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb | Day 85 | |
| Number of Participants With Seroconversion of Antigen-Specific bAbs |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | Contact | 1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Melbourne | Victoria | VIC 3004 | Australia | |
| Doherty Clinical Trials |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Day 85 |
| Not yet recruiting |
| Melbourne |
| Victoria |
| VIC 3149 |
| Australia |
| D014412 |
| Tumor Virus Infections |