No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
660 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for older adults and younger individuals with health conditions that increase their risk of severe COVID-19. Participants will receive a single injection and have follow-up calls over three months.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 65 years old, or I am 12 to 64 years old with health conditions that increase my risk for severe COVID-19.
I have received a COVID-19 vaccine at least 90 days before this trial.
I am not pregnant or breastfeeding.
I have taken a pregnancy test that shows I am not pregnant and I will use birth control or stay abstinent as required.
You may not be able to join if
I have a known immune deficiency or have taken immunosuppressive therapy in the past 6 months.
I have had a confirmed COVID-19 infection in the last 90 days.
I have a serious allergy to any part of this vaccine or have had a life-threatening reaction to it.
I have had myocarditis, pericarditis, or myopericarditis before.
I have received any vaccine within the last 28 days, except for the flu vaccine which I can have 14 days before.
I have received a COVID-19 vaccine within the last 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ≥ 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 ≥ 90 days prior…
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 ≥ 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 ≥ 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).
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
To be included in this study, each individual must satisfy all the following criteria:
* Participants ≥ 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…
Inclusion Criteria:
To be included in this study, each individual must satisfy all the following criteria:
* Participants ≥ 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 ≥ 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 ≥ 4 weeks before study vaccination through ≥ 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.
Contacts
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