COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05710783

None

None

2023-02-02

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: people ≥18 years old. any genre. have received their informed consent. negative pcr test for sars-cov-2 during the screening visit. negative pregnancy test in women with child-bearing potential. commitment to maintain adequate prevention measures to avoid contagion by sars-cov-2 throughout their participation in the study considering their strict following for the first 14 days after the baseline visit (use of face masks in closed places, social distancing measures in open spaces and frequent handwashing). have been vaccinated with any of the approved vaccines against sars-cov-2 (at least once).

history of hypersensibility or allergy to any of the vaccine compounds. history of severe anaphylactic reactions of any cause. fever at the baseline visit. active participation in any other clinical trial or experimental intervention within last 3 months. have received any vaccine (experimental or approved) within 30 days before baseline visit, except for influenza vaccine. the last anti-covid vaccination was less than 4 months ago. sars-cov-2 infection occurred in less than 1 month ago. pregnant or nursing women. child-bearing potential and sexually active women who do not use highly effective birth control methods (oral contraceptives, intrauterine device, subcutaneous implant, transdermal patch used at least within 3 months) at the time of enrolment. fertile and sexually active men not willing to strictly use (in all relationships) barrier methods of birth control throughout study. those participants (both sexes) not sexually active can participate in the study if they are committed to avoid sexual intercourse throughout study (6 months). chronic diseases that require use of immunosuppressive agents or immune response modulators (for instance: systemic corticosteroids, cyclosporine, rituximab, among others). cancer under active chemotherapy treatment. subjects with hiv infection history. subjects with chronic renal or liver disease who have shown an infectious condition that required hospitalization or treatment with intravenous drugs within the last year prior baseline visit.

7

Laboratorio Avi-Mex, S.A. de C.V.

18

100

Mexico

Healthy volunteers

N/A

4065

Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum;Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum;Phase II - T-cell elicited responses

None

Phase 2/Phase 3

[{"arm_notes": "Phase II - Experimental", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase III - Experimental", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase III - Security", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase II- Experimental", "treatment_id": 1082, "treatment_name": "Recombinant ndv vectored vaccine for sars-cov-2", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase II - Active Control", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase III - Active Control", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Phase II- Active Control", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]