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Influenza, Human

Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying mRNA Influenza Vaccine in Healthy Adults
NCT06028347 | Phase 1 | Interventional

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of one or two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Approximately 128 evaluable subjects will be enrolled in this study; n=96 receiving investigational vaccine and n=32 receiving placebo. The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).

Trial Information
2 Sites
128 Participants
18 Years to 85 Years

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Nucleus Network Brisbane Clinic
Nucleus network Melbourne Clinic

Study Eligibility Criteria

  • Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
  • Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
  • Individuals who can comply with study procedures including follow-up .
  • Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
  • Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
  • Progressive, unstable, or uncontrolled clinical conditions
  • Known hypersensitivity or allergy to any study vaccine component
  • Known history of Guillain-Barré syndrome or other demyelinating disease
  • Condition representing a contraindication to vaccination or blood draw
  • Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
  • Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
  • Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
  • Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.

Additional Studies

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