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Virus Therapy
Recombinant Protein COVID-19 Vaccines for COVID-19 (VAT00008 Trial)
Phase 3
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older on the day of inclusion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 22, day 43, day 78, day 134, day 202, day 292, and day 387
Awards & highlights
VAT00008 Trial Summary
This trial is testing two types of vaccines to see if they are effective in adults, as well as if they are safe and have few side effects. The trial will last for 365 days after the last initial injection, and participants may be asked to continue for an additional 12 months if they received the vaccine.
Who is the study for?
Adults aged 18+ who can attend all study visits, are not planning to get an authorized COVID-19 vaccine, and have health insurance if required. They must test negative for SARS-CoV-2 antibodies at enrollment and agree to effective contraception or abstinence. Excludes those with prior coronavirus vaccinations, certain medical conditions, recent anticoagulant use, or severe allergies to vaccine components.Check my eligibility
What is being tested?
The trial is testing two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as primary series shots and booster doses against COVID-19 in adults. Participants will be randomly assigned to receive either the vaccines or a placebo initially, followed by a crossover/booster phase.See study design
What are the potential side effects?
Potential side effects may include typical reactions like soreness at the injection site, fatigue, headache, muscle pain, chills, feverish feelings; less common might be allergic reactions or more significant immune responses.
VAT00008 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
VAT00008 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 22, day 43, day 78, day 134, day 202, day 292, and day 387
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 22, day 43, day 78, day 134, day 202, day 292, and day 387
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrences of symptomatic COVID-19
Presence of adverse events of special interest
Presence of immediate adverse events
+5 moreSecondary outcome measures
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
Death associated with COVID-19
Neutralizing antibody titer
+13 moreVAT00008 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2: SARS-CoV-2 vaccineExperimental Treatment2 Interventions
2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22
Group II: Stage 1: SARS-CoV-2 vaccineExperimental Treatment2 Interventions
2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22
Group III: Stage 1: PlaceboPlacebo Group2 Interventions
2 injections of placebo at Day 1 and Day 22
Group IV: Stage 2: PlaceboPlacebo Group2 Interventions
2 injections of placebo at Day 1 and Day 22
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Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
408 Previous Clinical Trials
6,070,579 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
1,996,671 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called thrombocytopenia that makes it unsafe for you to receive a vaccine through a muscle injection, according to the doctor's decision.I have received a coronavirus vaccine.I am not pregnant or breastfeeding, and either cannot have children or will use birth control.You had a very serious reaction to a vaccine or are allergic to any of the ingredients in the vaccine.I do not plan to get a COVID-19 vaccine despite being advised to.I am 18 years old or older.I have HIV, am on antiretrovirals, and my CD4 count is over 200.I haven't received vaccines 30 days before or plan to within 30 days after the study vaccine, except for the flu shot.I can attend all required visits and follow the study's procedures.You will be tested to see if you have antibodies for the virus that causes COVID-19 when you join the study.I have a bleeding disorder or have taken blood thinners in the last 21 days.I do not plan to get a COVID-19 vaccine despite being encouraged to.I have not had an organ or bone marrow transplant in the last 6 months.I have not received chemotherapy in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1: SARS-CoV-2 vaccine
- Group 2: Stage 1: Placebo
- Group 3: Stage 2: SARS-CoV-2 vaccine
- Group 4: Stage 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Coronavirus Patient Testimony for trial: Trial Name: NCT04904549 — Phase 3
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