Clinical trial NCT06604767: Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
Official title: A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infection
Metapneumovirus Infection
Parainfluenzae Virus Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Modified double-blind study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The study duration will be up to approximately 12 months minus the screening period.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
* Informed consent form (ICF) has been signed and dated
* A female participant is eligible to participate if she 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.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
timeFrame: Within 30 minutes after each vaccination
measure: Presence of solicited administration site reactions within 7 days after vaccination
timeFrame: Within 7 days after vaccination
measure: Presence of solicited systemic reactions within 7 days after vaccination
timeFrame: Within 7 days after vaccination
measure: Presence of unsolicited AEs within 28 days after vaccination
timeFrame: Within 28 days after vaccination
measure: Presence of serious adverse events (SAEs)
timeFrame: Within 6 months after vaccination
measure: Presence of adverse events of special interest (AESIs)
timeFrame: Within 6 months after vaccination
measure: Presence of related SAEs throughout the study
timeFrame: Throughout the study, approximately 12 months
measure: Presence of related AESIs throughout the study
timeFrame: Throughout the study, approximately 12 months
measure: Presence of related fatal SAEs throughout the study
timeFrame: Throughout the study, approximately 12 months
measure: Presence of out-of-range biological test results (including shift from baseline values)
timeFrame: Within 7 days after vaccination
Secondary outcomes:
measure: 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
timeFrame: At Day 01 and Day 29
measure: RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
timeFrame: At Day 01 and Day 29
measure: hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
timeFrame: At Day 01 and Day 29
measure: PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
timeFrame: At Day 01 and Day 29
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Investigational Site Number : 0360006
state: New South Wales
city: Botany
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Brookvale
country: Australia
facility: Investigational Site Number : 0360009
state: New South Wales
city: Kanwal
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: Miranda
country: Australia
facility: Investigational Site Number : 0360004
state: New South Wales
city: Herston
country: Australia
facility: Investigational Site Number : 0360008
state: Queensland
city: Bayswater
country: Australia
facility: Investigational Site Number : 0360003
state: Victoria
city: Camberwell
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
Study officials:
References: