COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537208

Sanofi Pasteur

Contact-US@sanofi.com

2020-09-03

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: aged 18 years of age or older on the day of inclusion. informed consent form had been signed and dated. able to attend all scheduled visits and complied with all study procedures.

participant was pregnant, or lactating, or of childbearing potential and not used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. to be considered of non-childbearing potential, a female was post-menopausal for at least 1 year or surgically sterile. receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines. prior administration of a coronavirus vaccine sars-cov-2, sars-cov, middle east respiratory syndrome). known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). history of sars-cov-2 infection, confirmed either clinically, serologically, or microbiologically chronic illness or condition considered to potentially increase the risk for severe covid illness or that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion. receipt of any therapy known to had in-vitro antiviral activity against sars-cov-2 within 72 hours prior to the first blood drew. health care workers provided direct participant care for covid-19 participants. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

11

Sanofi Pasteur, a Sanofi Company

18

100

United States

Healthy volunteers

N/A

441

Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22;Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36;Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1;Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22;Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36;Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36;Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22;Number of Participants With Adverse Events of Special Interest (AESIs);Number of Participants With Immediate Unsolicited Adverse Events (AEs);Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance;Number of Participants With Medically Attended Adverse Events (MAAE);Number of Participants With Serious Adverse Events (SAE);Number of Participants With Solicited Injection Site Reactions;Number of Participants With Solicited Systemic Reactions;Number of Participants With Unsolicited Adverse Events;Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22;Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36

None

Phase 1/Phase 2

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