Study of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older

INTERVENTION: PLACEBO vaccine injection CONDITION: ; covid 19 disease covid 19 disease PRIMARY OUTCOME: Efficacy To assess, in participants who are SARS‐CoV‐2 naïve, the clinical efficacy of the CoV2 preS dTM‐AS03 vaccines for the prevention of symptomatic COVID‐19 occurring = 14 days after the second injection Occurrences of symptomatic COVID‐19 . safety To assess the safety of the CoV2 preS dTM‐AS03 vaccines compared to placebo throughout the study.For participants in the Reactogenicity Subset: • Presence of solicited (pre‐listed in the participant’s diary card / electronic diary card [DC/eDC] and [electronic] Case Report Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days after each; vaccination • Presence of non‐serious unsolicited adverse events (AEs) reported up to 21 days after the last vaccination For all participants in the study:; • Presence of unsolicited injection site and systemic AEs reported in the 30 minutes after each vaccination; • Presence of medically‐attended adverse events (MAAEs) throughout the study; • Presence of serious adverse events (SAEs) throughout the study; • Presence of adverse events of special interest (AESIs) throughout the study; • Presence of virologically‐confirmed SARSCoV‐2 infections and/or symptomatic COVID‐ 19 SECONDARY OUTCOME: 1) To assess, in participants who are SARS‐CoV‐2 naïve, the clinical efficacy of the CoV2 preS dTM‐AS03 vaccines for prevention of the following occurring = 14 ; days after the second injection: • Prevention of SARS‐CoV‐2 infection and • Prevention of severe COVID‐19 /Endpoints for secondary efficacy objective #1: ; • Occurrences of SARS‐CoV‐2 infection and • Occurrence of severe COVID‐19 2) To assess, in participants who are SARS‐CoV‐2 naïve,the clinical efficacy of the CoV2 preS dTM‐AS03 vaccines for the prevention of symptomatic COVID‐19 occurring = 14 days after the first injection /Endpoint for secondary efficacy objective #2: • Occurrences of symptomatic COVID‐19/3) To assess, in all participants regardless of prior SARSCoV‐ 2 infection, the clinical efficacy of the CoV2 preS INCLUSION CRITERIA: Age I01: Aged 18 years or older on the day of inclusion Type of participant and disease characteristics I02: For persons living with HIV, stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3 I03: SARS‐CoV‐2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS‐CoV‐2 antibodies I04: Does not intend to receive an authorized/approved COVID‐19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollmenta Sex, contraceptive/barrier method and pregnancy testing requirements I05: 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.