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| ID | Type | Description | Link |
|---|---|---|---|
| VAV00027 | Other Identifier | Sanofi Identifier | |
| U1111-1295-2931 | Registry Identifier | ICTRP |
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The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.
Treatment:
Study duration per participant is approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV/hMPV mRNA / LNP 1 Group 1 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1. |
|
| RSV/hMPV mRNA / LNP 1 Group 2 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2. |
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| RSV/hMPV mRNA / LNP 1 Group 3 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3. |
|
| RSV/hMPV mRNA / LNP 2 Group 4 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1. |
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| RSV mRNA / LNP 1 Group 5 | Experimental | Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV/hMPV mRNA LNP 1 | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of unsolicited systemic immediate adverse events (AEs) | Number of participants experiencing immediate an immediate unsolicited systemic adverse event | Within 30 minutes after vaccination |
| Presence of solicited injection site or systemic reactions | Number of participants reporting:
| Within 7 days after vaccination |
| Presence of unsolicited AEs | Number of participants experiencing unsolicited AEs | Within 28 days after vaccination |
| Presence of medically attended adverse events (MAAEs) | Number of participants experiencing MAAEs | Throughout study (up to approximately 6 months) |
| Presence of serious adverse events (SAEs) | Throughout study (up to approximately 6 months) | Throughout study (up to approximately 6 months) |
| Presence of adverse events of special interest (AESIs) | Number of participants experiencing AESIs | Throughout study (up to approximately 6 months) |
| Presence of out-of-range biological test results | Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values) |
| Measure | Description | Time Frame |
|---|---|---|
| RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation | RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 |
| RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation |
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Inclusion Criteria:
-Informed consent form (ICF) has been signed and dated
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.
--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 |
|---|---|---|---|---|---|---|
| Velocity Gardena Site Number : 8400011 | Gardena | California | 90247 | United States | ||
| Velocity Clinical Research-Hallandale Beach- Site Number : 8400013 |
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| Label | URL |
|---|---|
| VAV00027 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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| hMPV mRNA / LNP 1 Group 6 |
| Experimental |
Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1. |
|
| RSV/hMPV mRNA / LNP 1 Group 7 | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4. |
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| RSV/hMPV mRNA LNP 2 | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
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| RSV mRNA LNP 1 | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
|
| hMPV mRNA LNP 1 | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
|
| Within 7 days after vaccination |
| RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations | RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 |
| RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations | RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 |
| hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations | hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination | Day 1 and Day 29 |
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination |
| Day 1, Day 29, Day 91 and Day 181 |
| RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation | RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 |
| hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations | hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 |
| hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations | hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination | Day 1, Day 29, Day 91 and Day 181 |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Advanced Clinical Research- Site Number : 8400005 | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research, Sioux City Site Number : 8400017 | Sioux City | Iowa | 51106 | United States |
| Velocity Clinical Research- New Orleans Site Number : 8400016 | New Orleans | Louisiana | 70119 | United States |
| Meridian Clinical Research- Site Number : 8400007 | Binghamton | New York | 13905 | United States |
| Velocity Clinical Research- Site Number : 8400012 | Cleveland | Ohio | 44122 | United States |
| Coastal Carolina Research Center- Site Number : 8400001 | North Charleston | South Carolina | 29405 | United States |
| Charlottesville Medical Research Center Winding River - Site Number : 8400002 | Charlottesville | Virginia | 22911 | United States |
| Investigational Site Number : 0360006 | Blacktown | New South Wales | 2148 | Australia |
| Investigational Site Number : 0360002 | Botany | New South Wales | 2019 | Australia |
| Investigational Site Number : 0360003 | Kanwal | New South Wales | 2259 | Australia |
| Investigational Site Number : 0360004 | Sydney | New South Wales | 2035 | Australia |
| Investigational Site Number : 0360008 | Herston | Queensland | 4006 | Australia |
| Investigational Site Number : 0360005 | Morayfield | Queensland | 4506 | Australia |
| Investigational Site Number : 0360001 | Camberwell | Victoria | 3124 | Australia |
| Investigational Site Number : 0360007 | Canberra | 2617 | Australia |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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