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Completed

NCT Number: NCT05972174

A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Victoria Infirmary, Newcastle upon Tyne, England, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
  • Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
  • 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.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Participant has received any vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
  • Participant has 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.

Other inclusion/exclusion criteria may apply.

Treatment and study plan

mRNA-1018 for H5N8

Biological

Sterile liquid for injection

mRNA-1018 for H7N9

Biological

Sterile liquid for injection

mRNA-1018 for H5 Only

Biological

Sterile liquid for injection

mRNA-1018 for H7 Only

Biological

Sterile liquid for injection

mRNA-1018 for H5 Only-CG

Biological

Sterile liquid for injection

Primary outcomes

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

    Time frame: Up to Day 29 (7 days after each injection)

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

    Time frame: Up to Day 43 (21 days after each injection)

  3. Number of Participants with AEs Leading to Discontinuation From Study

    Time frame: Day 1 to Day 205 (end of study [EoS])

  4. Number of Participants with Medically-Attended AEs (MAAEs)

    Time frame: Day 1 to Day 205 (EoS)

  5. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Day 1 to Day 205 (EoS)

  6. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Day 1 to Day 205 (EoS)

Secondary outcomes

  1. Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay

    Time frame: Days 22, 29, and 43

  2. Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay

    Time frame: Baseline (Day 1), Days 22, 29, and 43

  3. Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay

    Time frame: Baseline (Day 1) to Days 22, 29, and 43

    Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.

  4. Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43

    Time frame: Days 22, 29, and 43

  5. GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay

    Time frame: Days 22, 29, and 43

  6. GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay

    Time frame: Baseline (Day 1), Days 22, 29, and 43

  7. Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise

    Time frame: Baseline (Day 1) to Days 22, 29, and 43

    Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is <LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Jul 16, 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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