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OpenTrials
Completed

NCT Number: NCT05426174

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AES - DRS - Optimal Research_Site 8400007, Huntsville, Alabama, United States

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About this study

This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years or older on the day of inclusion.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
  • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration
  • A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention.
  • Informed consent form has been signed and dated.

Exclusion criteria

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
  • Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
  • Have any diagnosis, current or past, of autoimmune disease.
  • Body mass index of 40 kg/m2 or higher.
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
  • Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
  • Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

Treatment and study plan

mRNA NA vaccine

Biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

High Dose Quadrivalent Influenza Vaccine

Biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Other names: Fluzone HD

Primary outcomes

  1. Number of participants with immediate adverse events

    Time frame: Within 30 minutes after vaccination

    Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

  2. Number of participants with solicited injection site or systemic reaction

    Time frame: From Day 1 to Day 8

  3. Number of participants with unsolicited adverse events

    Time frame: From Day 1 to Day 29

    Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions

  4. Number of participants with serious adverse events

    Time frame: From Day 1 to Day 366

    Serious adverse events are collected throughout the study

  5. Number of participants with adverse events of special interest

    Time frame: From Day 1 to Day 366

    Adverse events of special interest are collected throughout the study

  6. Number of patients with clinically significant changes in clinical laboratory tests

    Time frame: From Day 1 to Day 8

    Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen

Secondary outcomes

  1. Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29

    Time frame: Day 1 and 29

    Antibody are expressed as GMTs at baseline and post-baseline

  2. Individual Neuraminidase inhibition (NAI) titer

    Time frame: Day 1 and Day 29

    Antibody titers are expressed as GMTs at baseline and post-baseline

  3. 2-fold and 4-fold rise in NAI antibody titers

    Time frame: From Day 1 to Day 29

    Expressed as percentage post-baseline

  4. Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]

    Time frame: Day 1 and Day 29

    Expressed as percentage at baseline and post-baseline

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Sep 15, 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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