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SARS-CoV-2 mRNA vaccine formulation 2 for COVID-19 (VAW00001 Trial)

Phase 1 & 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-vaccination); day 22 (post-vaccination), day 36 (post-vaccination), day 91 (only for cohort 1), day 112 (only for cohort 2), day 181 (only for cohort 1), and day 202 (only for cohort 2)
Awards & highlights

VAW00001 Trial Summary

Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older

Eligible Conditions
  • COVID-19
  • Coronavirus

VAW00001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-vaccination); day 22 (post-vaccination), day 36 (post-vaccination), day 91 (only for cohort 1), day 112 (only for cohort 2), day 181 (only for cohort 1), and day 202 (only for cohort 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-vaccination); day 22 (post-vaccination), day 36 (post-vaccination), day 91 (only for cohort 1), day 112 (only for cohort 2), day 181 (only for cohort 1), and day 202 (only for cohort 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1
+12 more
Secondary outcome measures
Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
+7 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

VAW00001 Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low doseExperimental Treatment1 Intervention
Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.
Group II: Sentinel Cohort: SARS-CoV-2 Vaccine Medium doseExperimental Treatment1 Intervention
Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.
Group III: Sentinel Cohort: SARS-CoV-2 Vaccine Low doseExperimental Treatment1 Intervention
Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Group IV: FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low doseExperimental Treatment1 Intervention
Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.
Group V: FEC Cohort 2: SARS-CoV-2 Vaccine Low doseExperimental Treatment1 Intervention
Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Group VI: FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low doseExperimental Treatment1 Intervention
Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.
Group VII: FEC Cohort 1: SARS-CoV-2 Vaccine Low doseExperimental Treatment1 Intervention
Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.
Group VIII: FEC Cohort 2: PlaceboPlacebo Group1 Intervention
Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Group IX: FEC Cohort 1: PlaceboPlacebo Group1 Intervention
Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,799 Total Patients Enrolled
5 Trials studying COVID-19
27,686 Patients Enrolled for COVID-19
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,656 Total Patients Enrolled
3 Trials studying COVID-19
27,552 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
2021. "Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04798027.
~45 spots leftby Apr 2025
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