Status:
COMPLETED
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the ...
Eligibility Criteria
Inclusion
- 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 .
Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06028347
Start Date
October 5 2023
End Date
October 13 2024
Last Update
November 27 2024
Active Locations (2)
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1
Nucleus Network Brisbane Clinic
Brisbane, Queensland, Australia, 4006
2
Nucleus network Melbourne Clinic
Melbourne, Victoria, Australia, 3004