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This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAL-339851 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAL-339851 | Biological | Escalating dose levels |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of solicited AEs (local and systemic reactogenicity events) | 7 days following each dose administration | |
| Frequency of unsolicited adverse events | 21 days following each dose administration | |
| Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness | One year after last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample | One year after last dose administration | |
| Seroconversion rates in comparison to baseline samples | One year after last dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31079849 | Derived | Feldman RA, Fuhr R, Smolenov I, Mick Ribeiro A, Panther L, Watson M, Senn JJ, Smith M, Almarsson Ó¦, Pujar HS, Laska ME, Thompson J, Zaks T, Ciaramella G. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine. 2019 May 31;37(25):3326-3334. doi: 10.1016/j.vaccine.2019.04.074. Epub 2019 May 10. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Double blind
| Other |
Saline |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |