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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1304-9362 | Registry Identifier | WHO ICTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIV3 Dose 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| PIV3 Dose 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| PIV3 Dose 3 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
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| PIV3 Dose 4 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| RSV/hMPV /PIV3 Formulation 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| RSV/hMPV Formulation 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parainfluenza virus type 3 vaccine (PIV3) | Biological | Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination | Number of participants experiencing immediate unsolicited systemic AEs | 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 | Within 7 days after vaccination |
| Presence of solicited systemic reactions within 7 days after vaccination | Number of participants reporting:
| Within 7 days after vaccination |
| Presence of unsolicited AEs within 28 days after vaccination | Number of participants experiencing unsolicited AEs | Within 28 days after vaccination |
| Presence of serious adverse events (SAEs) | Number of participants experiencing SAEs regardless of causality | Within 6 months after vaccination |
| Presence of adverse events of special interest (AESIs) | Number of participants experiencing AESIs regardless of causality | Within 6 months after vaccination |
| Presence of related SAEs throughout the study | Number of participants experiencing related SAEs regardless of causality |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 0360006 | Blacktown | New South Wales | 2148 | Australia | ||
| Investigational Site Number : 0360001 |
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| Label | URL |
|---|---|
| VBD00006 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Modified double-blind study
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-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
Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| RSV/hMPV Formulation 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
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| RSV vaccine 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| RSV vaccine 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 |
|
| RSV/hMPV/PIV3 vaccine | Biological | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
|
| RSV/hMPV vaccine | Biological | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
|
| RSV vaccine 1 | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
|
| RSV vaccine 2 | Biological | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
|
| Throughout the study, approximately 12 months |
| Presence of related AESIs throughout the study | Number of participants experiencing related AESIs regardless of causality | Throughout the study, approximately 12 months |
| Presence of related fatal SAEs throughout the study | Number of participants experiencing related fatal SAEs regardless of causality | 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) | Within 7 days after vaccination |
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination |
| 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 | 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 | At Day 01 and Day 29 |
| Botany |
| New South Wales |
| 2019 |
| Australia |
| Investigational Site Number : 0360009 | Brookvale | New South Wales | 2100 | Australia |
| Investigational Site Number : 0360005 | Kanwal | New South Wales | 2259 | Australia |
| Investigational Site Number : 0360004 | Miranda | New South Wales | 2228 | Australia |
| Investigational Site Number : 0360008 | Herston | Queensland | 4006 | Australia |
| Investigational Site Number : 0360003 | Bayswater | Victoria | 3153 | Australia |
| Investigational Site Number : 0360002 | Camberwell | Victoria | 3124 | Australia |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D018184 | Paramyxoviridae Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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