COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
Product Code: 549
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not Applicable
Current Sponsor code: 549
Other descripti
Sponsors
Sanofi Pasteur Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Aged 18 years or older on the day of inclusion. -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 vaccination until at least 12 weeks after the second vaccination. A participant of childbearing potential must have a negative highlysensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. -Informed consent form has been signed and dated. -Able to attend all scheduled visits and to comply with all study procedures. -SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort). -For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3. -Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment. -Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2. -Supplemental cohorts, booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5084 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 328
Exclusion criteria
Exclusion criteria: -Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to a vaccine containing any of the same substances. -Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee’s judgment. -Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment. -Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’s judgment. -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. -Receipt of solid-organ or bone marrow transplants in the past 180 days. -Receipt of anti-cancer chemotherapy in the last 90 days. -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 trial until the condition has resolved or the febrile event has subsided. -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. -Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group, and Supplemental Variant Prime Cohort 3 Groups: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). -Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. -Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group and for the 3 Supplemental Variant Prime Cohort 3 groups: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment. -Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study): Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2Cohort. -Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV2 infection (by NAAT) after first dose of primary immunization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1-Presence of immediate adverse events : Immediate adverse events include unsolicited adverse events occurring within 30 minutes after injection 2-Presence of solicited injection site or systemic reactions : Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia. 3-Presence of unsolicited adverse events : Adverse events other than solicited reactions 4-Presence of serious adverse events : Serious adverse events are reported throughout the study 5-Presence of adverse events of special interest : Adverse events of special interest are reported throughout the study. 6-Presence of medically-attended adverse events : Medically-attended adverse events are new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department. 7-Neutralizing antibody titer at Day 1 : Neutralizing antibody titers are expressed as geometric mean titers 8-Neutralizing antibody titer at Day 36 : Neutralizing antibody titers are expressed as geometric mean titers. 9-Neutralizing antibody titer fold-rise post vaccination : Neutralizing antibody titer fold-rise post-vaccination. 10- 2-fold rise and 4-fold-rise in neutralization antibody titer : Fold-rise in antibody neutralization titer post-vaccination relative to Day 1. 11-Responders, as determined by neutralizing antibody titers at Day 36 : Responders, defined as participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at Day 36 12-Neutralizing antibody titer at Day 1 (pre-booster injection): Neutralizing antibody titers are expressed as geometric mean titers. 13-Neutralizing antibody titer at Day 15 (post booster injection) : Neu | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Neutralizing antibody titer at all pre-defined time points 2.Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points : Fold-rise in antibody neutralization titer post-vaccination relative to Day 1. 3. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points : Fold-rise in antibody neutralization titer post-vaccination relative to Day 1. 4.Responders, as determined by neutralizing antibody titers at each pre-defined time point : Responders, defined as participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at each pre-defined timepoint. 5.Binding antibody concentrations 6.Binding antibody fold-rise : Fold-rise in concentration relative to Day 1. 7.2-fold-rise and 4-fold rise in binding antibody concentration : Fold-rise in concentration relative to Day 1. 8.Responders, as determined by binding antibody concentrations : Responders are defined as participants who had baseline values below LLOQ with detectable anti concentration above assay LLOQ at each predefined time point and participants with baseline values above LLOQ with a 4-fold increase in anti-S antibody concentration at each pre-defined time point. 9.Occurrences of laboratory-confirmed symptomatic COVID-19 : Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Laboratory-confirmed SARS-CoV-2 infection is defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT), done by the central laboratory or locally, on at least one respiratory sample. 10.Occurrences of symptomatic COVID-19 episodes associated with hospitalization : Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19 | — |
Countries
Australia, Honduras, Spain, United Kingdom, United States
Contacts
Public ContactUnidad Estudios Clinicos
sanofi-aventis, s.a.
Outcome results
None listed