The primary objectives of the study were: - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: - To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. - To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. - To describe the occurrence of virologically-confirmed coronavirus disease (COVID-19)-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
The duration of each participant's participation in the study was approximately 365 days
(Cohort 1) and 386 days (Cohort 2) post last injection.
Biological: CoV2 preS dTM-AF03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Biological: CoV2 preS dTM-AF03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Biological: CoV2 preS dTM-AS03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Biological: CoV2 preS dTM-AS03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Biological: CoV2 preS dTM (high-dose) without adjuvant
Pharmaceutical form: liquid; route of administration: intramuscular injection
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
Exclusion Criteria:
- 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.
Investigational Site Number 8400004
Birmingham, Alabama, United States
Investigational Site Number 8400012
Rolling Hills Estates, California, United States
Investigational Site Number 8400011
Hollywood, Florida, United States
Investigational Site Number 8400019
Melbourne, Florida, United States
Investigational Site Number 8400016
Boston, Massachusetts, United States
Investigational Site Number 8400002
Omaha, Nebraska, United States
Investigational Site Number 8400001
Rochester, New York, United States
Investigational Site Number 8400007
Rochester, New York, United States
Investigational Site Number 8400008
Cleveland, Ohio, United States
Investigational Site Number 8400003
Philadelphia, Pennsylvania, United States
Investigational Site Number 8400014
Mount Pleasant, South Carolina, United States
Clinical Sciences & Operations, Study Director
Sanofi Pasteur, a Sanofi Company