A Study of Modified mRNA Vaccines in Healthy Adults

Phase
Recruitment status
Participants
Lead sponsor
ModernaTX, Inc.
Start date
Number of sites

Summary
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Short title
A Study of Modified mRNA Vaccines in Healthy Adults
Official title
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
ModernaTX, Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design

  1. Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Timeframe: Up to Day 176 (7 days follow-up post-vaccination)

  2. Number of Participants With Unsolicited Adverse Events (AEs)

    Timeframe: Up to Day 197 (28 days follow-up post-vaccination)

  3. Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination

    Timeframe: Day 1 through end of study (EOS) (up to Day 1249)

  4. Number of Participants with Medically Attended Adverse Events (MAAEs)

    Timeframe: Day 1 through Day 361

  1. Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345

    Timeframe: Days 1 (Baseline), 29, 85, and 197

  2. Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345

    Timeframe: Days 1 (Baseline), 29, 85, and 197

  3. Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647

    Timeframe: Days 1 (Baseline), 29, 85, and 197

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
Yes

  • Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
  • Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit.

  • Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
  • Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
  • Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19.
  • Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19.
  • Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
  • Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination.

Other inclusion and exclusion criteria may apply.

Sources for eligibility

  • CenExelHollywood, United States
  • Meridian Clinical ResearchSavannah, United States
  • Meridian Clinical ResearchSioux City, United States
  • Johnson County Clinical TrialsLenexa, United States
  • Meridian Clinical ResearchLincoln, United States
  • Benchmark ResearchAustin, United States
  • Tekton Research, IncAustin, United States
  • DM Clinical Research- Texas Center for Drug DevelopmentHouston, United States
Sources for sites

Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)