COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=13475

Tirhani Maluleke

Tirhani.Maluleke@sanofi.com

2020-11-02

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Participants are eligible for the study only if all of the following criteria are met: I01: Aged 18 years or older on the day of inclusion I02: A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. OR • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the second vaccination. A subject of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. I03: Informed consent form has been signed and dated I04: Able to attend all scheduled visits and to comply with all trial procedures I05: Covered by health insurance, only if required by local, regional or national regulations I06: SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies I07: For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on ARVs with CD4 count > 200/mm3

Participants are not eligible for the trial if any of the following criteria are met: E01: Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure E02: Receipt of any vaccine in the 30 days preceding or on the day of the first trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention a. E03: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]) E04: Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances b. E05: Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee’s judgment E06: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator or designee’s judgment E07: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator or designee’s judgment E08: Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily E09: Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the trial procedures E10: Receipt of solid-organ or bone marrow transplants in the past 180 days E11: Receipt of anti-cancer chemotherapy in the last 90 days

2

N/A

18

99

Kenya

Healthy volunteers

N/A

34520

To assess the clinical efficacy of the investigational SARS-CoV-2 Recombinant Protein vaccine (with adjuvant) in SARS-CoV-2 naïve adults for the prevention of symptomatic COVID-19 occurring = 14 days after the second injection.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "2", "treatment_id": 1701, "treatment_name": "As03 adjuvant+sars-cov-2 recombinant protein vaccine", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}]