The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study. Overall, the study is designed to: * Assess the safety profile of the candidate formulations * Describe the immunogenicity profile of the candidate formulations * Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations. Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs). Participants will also be required to record their daily temperature on the diary.
The duration of study participation will be approximately 6 months for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
270
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Suspension for injection in a vial. Route of administration: IM injection
Solution for injection in a prefilled syringe. Route of administration: IM injection
Paratus Clinical
Blacktown, New South Wales, Australia
Paratus Clinical
Herston, Queensland, Australia
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, Australia
Griffith University
Southport, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Number of participants with unsolicited systemic AEs
Time frame: Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Number of participants with solicited injection site and systemic reactions
Time frame: Through 7 days after each vaccination
Presence of unsolicited AEs reported through 28 days after vaccination
Number of participants with unsolicited AEs
Time frame: Through 28 days after each vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
: Number of participants with SAEs and AESIs
Time frame: Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
: Number of participants with out-of-range biological tests
Time frame: Through 7 days after vaccination
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Time frame: Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Time frame: Day 1 and Day 29
RSV B and hMPV A nAb titers at Day 1 and Day 29
Time frame: Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Time frame: Day 29
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