Metapneumovirus Infection, Parainfluenzae Virus Infection, Respiratory Syncytial Virus Infection
Conditions
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.
Interventions
BIOLOGICALparainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
BIOLOGICALRSV/hMPV/PIV3 vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
BIOLOGICALRSV/hMPV vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
BIOLOGICALRSV vaccine 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICALRSV vaccine 2
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
-Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts
Intervention model description
Modified double-blind study
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination | Within 30 minutes after each vaccination | Number of participants experiencing immediate unsolicited systemic AEs |
| Presence of solicited administration site reactions within 7 days after vaccination | Within 7 days after vaccination | Number of participants reporting: \- injection site reactions: pain, erythema and swelling |
| Presence of solicited systemic reactions within 7 days after vaccination | Within 7 days after vaccination | Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills |
| Presence of unsolicited AEs within 28 days after vaccination | Within 28 days after vaccination | Number of participants experiencing unsolicited AEs |
| Presence of serious adverse events (SAEs) | Within 6 months after vaccination | Number of participants experiencing SAEs regardless of causality |
| Presence of adverse events of special interest (AESIs) | Within 6 months after vaccination | Number of participants experiencing AESIs regardless of causality |
| Presence of related SAEs throughout the study | Throughout the study, approximately 12 months | Number of participants experiencing related SAEs regardless of causality |
| Presence of related AESIs throughout the study | Throughout the study, approximately 12 months | Number of participants experiencing related AESIs regardless of causality |
| Presence of related fatal SAEs throughout the study | Throughout the study, approximately 12 months | Number of participants experiencing related fatal SAEs regardless of causality |
| Presence of out-of-range biological test results (including shift from baseline values) | Within 7 days after vaccination | Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At Day 01 and Day 29 | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination |
| RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines | At Day 01 and Day 29 | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination |
| hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines | At Day 01 and Day 29 | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination |
| PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines | At Day 01 and Day 29 | Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination |
Countries
Australia
Outcome results
None listed