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Cancer Vaccine

mRNA-1083 Vaccine for Respiratory Infections

Phase 3
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 1 through day 181
Awards & highlights
Pivotal Trial

Study Summary

This trial studies the safety and effectiveness of two vaccines against influenza and SARS-CoV-2, in adults aged 50-65 and over 65.

Eligible Conditions
  • COVID-19
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 181
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay
+7 more
Secondary outcome measures
GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort B1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions
Participants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
Group II: Cohort A1: mRNA-1083 and PlaceboExperimental Treatment2 Interventions
Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
Group III: Cohort A2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions
Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
Group IV: Cohort B2: Influenza Vaccine and COVID-19 VaccineActive Control2 Interventions
Participants of age 50 to <65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
101 Previous Clinical Trials
61,360,121 Total Patients Enrolled
34 Trials studying COVID-19
61,242,570 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.

Are there any vacancies in this clinical trial for participants?

"Sadly, this medical trial is not currently enrolling patients. Although it was initially posted on October 19th 2023 and updated lastly on 18th of the same month, no new participants are being sought out at present. Nevertheless, 255 other studies have vacancies available for those interested in participating."

Answered by AI

How many healthcare facilities are currently undertaking this clinical trial?

"Over 170 facilities are participating in the trial, including Accel Research Site - Achieve - Birmingham from Birmingham and Cullman Clinical Trials from Cullman. Additionally, Lenzmeier Family Medicine - CCT - PPDS located in Glendale is also part of the study's current recruitment campaign."

Answered by AI

Is there a risk of adverse effects from the concurrent administration of an Influenza Vaccine and COVID-19 Vaccine in Cohort A2?

"Given the quantity of data supporting efficacy and multiple rounds of evidence affirming its safety, Cohort A2: Influenza Vaccine and COVID-19 Vaccine scored a 3 on our team's scale."

Answered by AI

Who else is applying?

What site did they apply to?
Suncoast Research Group LLC - Flourish - PPDS
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
Empire Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
2023. "A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097273.
All > Pflugerville Tx > Paid Studies Pasadena
~0 spots leftby Dec 2023
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