The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
The study duration will be up to approximately 12 months minus the screening period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
390
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Investigational Site Number : 0360006
Blacktown, New South Wales, Australia
Investigational Site Number : 0360001
Botany, New South Wales, Australia
Investigational Site Number : 0360009
Brookvale, New South Wales, Australia
Investigational Site Number : 0360005
Kanwal, New South Wales, Australia
Investigational Site Number : 0360004
Miranda, New South Wales, Australia
Investigational Site Number : 0360008
Herston, Queensland, Australia
Investigational Site Number : 0360003
Bayswater, Victoria, Australia
Investigational Site Number : 0360002
Camberwell, Victoria, Australia
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Time frame: Within 30 minutes after each vaccination
Presence of solicited administration site reactions within 7 days after vaccination
Number of participants reporting: \- injection site reactions: pain, erythema and swelling
Time frame: Within 7 days after vaccination
Presence of solicited systemic reactions within 7 days after vaccination
Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Time frame: Within 7 days after vaccination
Presence of unsolicited AEs within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Time frame: Within 28 days after vaccination
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs regardless of causality
Time frame: Within 6 months after vaccination
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs regardless of causality
Time frame: Within 6 months after vaccination
Presence of related SAEs throughout the study
Number of participants experiencing related SAEs regardless of causality
Time frame: Throughout the study, approximately 12 months
Presence of related AESIs throughout the study
Number of participants experiencing related AESIs regardless of causality
Time frame: Throughout the study, approximately 12 months
Presence of related fatal SAEs throughout the study
Number of participants experiencing related fatal SAEs regardless of causality
Time frame: Throughout the study, approximately 12 months
Presence of out-of-range biological test results (including shift from baseline values)
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Time frame: Within 7 days after vaccination
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Time frame: At Day 01 and Day 29
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Time frame: At Day 01 and Day 29
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Time frame: At Day 01 and Day 29
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Time frame: At Day 01 and Day 29
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