Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (18-64): 15 μg | Experimental |
| |
| Group 2 (18-64): 30 μg | Experimental |
| |
| Group 3 (18-64): 60 μg | Experimental |
| |
| Group 4 (18-64): STD TIV | Active Comparator |
| |
| Group 5 (65+): 30 μg | Experimental |
| |
| Group 6 (65+): 60 μg | Experimental |
| |
| Group 7 (65+): HD TIV | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Influenza vaccine candidate | Biological | Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate AEs | Percentage, intensity, and relationship to vaccination of immediate AEs (30 minutes post-vaccination) | 30 minutes |
| Solicited local and systemic AEs | Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs (for seven days following study vaccine administration) | 7 days |
| Unsolicited AEs | Percentage, intensity, and relationship of unsolicited AEs, including TEAEs, for 28 days following study vaccine administration | 28 days |
| Urine, haematological and blood biochemistry values | Number and percentage of participants with normal and abnormal, clinically significant urine, haematological and blood biochemistry values, and urinalysis at Screening visit and D3 (Phase 1 participants only) | Screening and Day 3 |
| Deaths, SAEs, AEs leading to withdrawal, TEAEs | Occurrences of deaths, SAEs, AEs leading to withdrawal, TEAEs, AESIs, NOCDs, and SUSARs up to the end of the study (D182) | 182 days |
| HI antibody response (GMT) | HI antibody response (GMT) induced in TVLP Groups versus commercial comparator Groups against the homologous influenza strains on D0 and D28 | Day 0 and Day 28 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Trepanier, Ph.D. | Contact | Canada: 1-418-655-7158 | Strepanier@aramisbiotechnologies.com | |
| Sebastien Soucy | Contact | Canada: 1-418-446-2032 | ssoucy@aramisbiotechnologies.com |
| Name | Affiliation | Role |
|---|---|---|
| Brian Ward, MD | McGill University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Center for Vaccinology (CCfV) - IWK Health | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Commercial Influenza vaccine | Biological | Influenza vaccine commercially available on the Canadian market |
|
| Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T 1C8 | Canada |
|
| Vaccine Study Centre of McGill University Health Centre | Recruiting | Pierrefonds | Quebec | H9H 4Y6 | Canada |
|
| CHU de Québec - Université Laval | Recruiting | Québec | Quebec | G1E 7G9 | Canada |
|
| Diex Recherche - Sherbrooke | Recruiting | Sherbrooke | Quebec | J1L 0H8 | Canada |
|
| Diex Recherche - Trois-Rivières | Recruiting | Trois-Rivières | Quebec | G9A 4P3 | Canada |
|
| Diex Recherche - Victoriaville | Recruiting | Victoriaville | Quebec | G6P 3Z8 | Canada |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |