covid 19 disease
Conditions
Interventions
PLACEBO
Vaccine
Sponsors
sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
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. OR • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention. Informed Consent I06: Informed consent form has been signed and dated Other Inclusions I07: Able to attend all visits and to comply with all study procedures I08: Covered by health insurance, only if required by local, regional or national regulations
Exclusion criteria
Exclusion criteria: E01: Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to a vaccine containing any of the same substancesa E02: Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator’s judgment E03: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment E04: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’s judgment E05: 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 study procedures E06: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C [= 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided E07: Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. E08: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERSCoV]) E09: Receipt of solid-organ or bone marrow transplants in the past 180 days E10: Receipt of anti-cancer chemotherapy in the last 90 days E11: Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure E12: Deprived of freedom by a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 dTM-AS03 vaccines for:• Prevention of symptomatic COVID-19 and • Prevention of severe COVID-19 /4) To assess, in participants who are SARS-CoV-2 nonnaïve, the clinical efficacy of the CoV2 preS dTMAS03 vaccines for: • Prevention of symptomatic COVID-19 and • Prevention of severe COVID-19//Endpoints for secondary efficacy objective #3 and 4 Occurrences of symptomatic COVID-19 and Occurrence of severe COVID-19/5) To assess, in participants who are SARS-CoV-2 naïve, the clinical efficacy of the CoV2 preS dTM-AS03 vaccines for the prevention of asymptomatic SARSCoV-2 infection./Endpoint for secondary efficacy objective #5:• Occurrences of asymptomatic SARS-CoV-2 infection/6) To assess the impact of the CoV2 preS dTM-AS03 vaccines in the reduction of viral burden and shedding among participants with symptomatic COVID-19 Endpoints for secondary efficacy objective #6:• Viral copies/mL in respiratory samples collected at each follow-up timepoint • Number of days with positive NAAT • Occurrences of positive NAAT in respiratory samples at each follow-up timepoint during symptomatic COVID-19 | — |
Countries
Ghana, Kenya, Nigeria, Uganda
Contacts
Public Contacthella ghrobel
regulatory officer
Outcome results
None listed