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OpenTrials
Completed

NCT Number: NCT05397223

A Study of Modified mRNA Vaccines in Healthy Adults

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

mRNA-1273

Biological

Sterile liquid for injection

mRNA-1010

Biological

Sterile liquid for injection

mRNA-1345

Biological

Sterile liquid for injection

Fluad®

Biological

adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine

mRNA-1647

Biological

Sterile lyophilized product

Primary outcomes

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

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

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

    Time frame: 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

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

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

    Time frame: Day 1 through Day 361

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Days 1 (Baseline), 29, 85, and 197

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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