AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19

RecruitingPhase 4Ages 12 Years - anyAllSanofi
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants โ‰ฅ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine โ‰ฅ 90 days prior to study vaccination. Study details include: * The study duration will be approximately 3 months per participant. * Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1. * The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: * Participants โ‰ฅ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination. * Previously vaccinated with a COVID-19 vaccine, with the last dose administered โ‰ฅ 90 days prior to study vaccination. * Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from โ‰ฅ 4 weeks before study vaccination through โ‰ฅ 4 weeks after vaccination. Exclusion Criteria: Participants are not eligible if any of the following criteria are met: * Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids. * History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination. * Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances. * Prior history of myocarditis, pericarditis, or myopericarditis. * Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination. * Receipt of an investigational or marketed COVID-19 vaccine within 90 days before study vaccination. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
๐Ÿ’Š

What it tests

  • Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
๐Ÿ“

Where

20 sites
Site #: 8400005
Fair Oaks, United States
Site #: 8400002
Doral, United States
Site #: 8400008
Atlanta, United States
Site #: 8400015
Decatur, United States
Site #: 8400011
Melrose Park, United States
Site #: 8400019
Sioux City, United States
Site #: 8400009
Lenexa, United States
Site #: 8400001
Lafayette, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy