Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
With
GlaxoSmithKline
The duration of each participant's participation in the study was approximately 365 days (Cohort 1) and 386 days (Cohort 2) post last injection.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.