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Completed

NCT Number: NCT05606965

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

About this study

The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
  • Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the Screening Visit. There will be no BMI requirement for inclusion in Part B and Part C.
  • A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or breastfeeding.

Exclusion criteria

  • Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
  • Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
  • Reported history of congenital or acquired immunodeficiency, immunocompromizing or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
  • Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
  • Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
  • Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
  • Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

mRNA-1010

Biological

Sterile liquid for injection

Egg-based Quadrivalent Influenza Vaccine

Biological

Sterile suspension for injection

Other names: Fluarix®

Adjuvanted Quadrivalent Influenza Vaccine

Biological

Sterile injectable emulsion

Other names: Fluad®

Inactivated Influenza Vaccine

Biological

Sterile suspension for injection

Other names: Fluzone®

mRNA-1345

Biological

Sterile liquid for injection

mRNA-1045

Biological

Sterile liquid for injection

Primary outcomes

  1. Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Time frame: Up to Day 7 (7 days after vaccination)

  2. Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)

    Time frame: Up to Day 28 (28 days after vaccination)

  3. Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation

    Time frame: Day 1 through Day 181

  4. Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay

    Time frame: Day 29

  5. Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B

    Time frame: Day 29

  6. Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay

    Time frame: Baseline, Day 29

  7. Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay

    Time frame: Baseline, Day 29

  8. Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay

    Time frame: Day 29

    Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.

  9. Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay

    Time frame: Day 29

    Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.

Secondary outcomes

  1. Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay

    Time frame: Days 121 and 181

  2. Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay

    Time frame: Days 57, 121, and 181

  3. Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay

    Time frame: Baseline, Days 121 and 181

  4. Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay

    Time frame: Baseline, Days 57, 121, and 181

  5. Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay

    Time frame: Days 57, 121, and 181

    Seroresponse is defined as a Day 57, 121, or 181 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.

  6. Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay

    Time frame: Days 57, 121, and 181

    Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is <LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Days 57, 121, or 181.

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2022
Registry last updated
Nov 24, 2025

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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