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The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1018-H5 Vaccine | Experimental | Participants will receive mRNA-1018-H5 vaccine by intramuscular (IM) injection on Day 1 and Day 22. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to mRNA-1018-H5 vaccine by IM injection on Day 1 and Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1018-H5 | Biological | Sterile liquid for injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 | HAI Titer >=1:40. | Day 43 |
| Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay | Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay. | Day 43 |
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 29 (7 days after each injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 50 (28 days after each injection) | |
| Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) | Day 1 to Day 205 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay | Day 43 | |
| GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay | Days 22 and 205 |
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Key Inclusion Criteria:
Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:
Key Exclusion Criteria:
Note: Other inclusion/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 |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, San Bernardino | Not yet recruiting | San Bernardino | California | 92408 | United States | |
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| Placebo |
| Biological |
Sterile liquid for injection. |
|
| GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay | Days 22 and 205 |
| Percentage of Participants with HAI Titers at Different Cut-Offs | Cutoff included >= 1:80. | Up to Day 205 |
| Velocity Clinical Research, Savannah |
| Not yet recruiting |
| Savannah |
| Georgia |
| 31406 |
| United States |
| Velocity Clinical Research, Boise | Not yet recruiting | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research, Rockville | Not yet recruiting | Rockville | Maryland | 20854 | United States |
| Velocity Clinical Research, Omaha | Not yet recruiting | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research, Cleveland | Recruiting | Beachwood | Ohio | 44122 | United States |
| Velocity Clinical Research, Providence | Recruiting | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research, Anderson | Not yet recruiting | Anderson | South Carolina | 29621 | United States |
| Velocity Clinical Research, Dallas | Recruiting | Dallas | Texas | 75230 | United States |
| Velocity Clinical Research, Suffolk | Not yet recruiting | Suffolk | Virginia | 23435 | United States |
| Velocity Clinical Research-Bristol | Not yet recruiting | Bristol | Bristol (Unitary Authority) | BS8 2RA | United Kingdom |
| Velocity Clinical Research - High Wycombe | Not yet recruiting | High Wycombe | Buckinghamshire | HP11 2QW | United Kingdom |
| Wansford Research Ltd | Not yet recruiting | Peterborough | Cambridgeshire | PE8 6PL | United Kingdom |
| Futuremeds Teesside Middlefield Centre University Hospital of North Tees | Not yet recruiting | Stockton-on-Tees | County Durham | TS19 8PE | United Kingdom |
| NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) | Not yet recruiting | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust) | Not yet recruiting | Weymouth | Dorset | DT4 0QE | United Kingdom |
| Panthera Glasgow | Not yet recruiting | Glasgow | Glasgow City (Scotland) | G51 4TF | United Kingdom |
| Panthera Enfield | Not yet recruiting | Enfield | Greater London | EN3 4GS | United Kingdom |
| Hounslow Medical Centre | Not yet recruiting | Hounslow | Greater London | TW3 3ET | United Kingdom |
| hVIVO Services Limited | Not yet recruiting | London | Greater London | E1 1EQ | United Kingdom |
| Velocity Clinical Research-North London | Not yet recruiting | London | Greater London | N12 8BU | United Kingdom |
| Accellacare North London | Not yet recruiting | Northwood | Greater London | HA6 2RN | United Kingdom |
| Accellacare South London | Not yet recruiting | Orpington | Greater London | BR5 3QG | United Kingdom |
| Velocity Clinical Research-Romford | Not yet recruiting | Romford | Greater London | RM1 3PJ | United Kingdom |
| Panthera Rochdale | Not yet recruiting | Rochdale | Greater Manchester | OL11 4AU | United Kingdom |
| NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT) | Not yet recruiting | Southampton | Hampshire | SO15 3UA | United Kingdom |
| Fylde Coast Clinical Research at Layton Medical Centre | Not yet recruiting | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| FutureMeds Liverpool | Not yet recruiting | Metropolitan Borough of Wirral | Merseyside | CH62 6EE | United Kingdom |
| Lakeside Healthcare | Not yet recruiting | Corby | North Northamptonshire | NN17 2UR | United Kingdom |
| Panthera York | Not yet recruiting | York | North Yorkshire | YO24 4LJ | United Kingdom |
| The University of Nottingham Health Service | Not yet recruiting | Nottingham | Nottinghamshire | NG7 2QW | United Kingdom |
| Panthera Sheffield | Not yet recruiting | Sheffield | South Yorkshire | S2 5FX | United Kingdom |
| FutureMeds Newcastle | Not yet recruiting | Newcastle upon Tyne | Tyne and Wear | NE61SG | United Kingdom |
| Accellacare Warwickshire | Not yet recruiting | Coventry | West Midlands (Coventry) | CV3 4FJ | United Kingdom |
| FutureMeds Birmingham Soho Road Health Centre | Not yet recruiting | Birmingham | West Midlands | B21 9RY | United Kingdom |
| Accellacare Yorkshire | Not yet recruiting | Shipley | West Yorkshire | BD18 3SA | United Kingdom |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
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