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| ID | Type | Description | Link |
|---|---|---|---|
| WHO UTN | Other Identifier | U1111-1321-1812 |
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The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age.
-Each participant will remain in the study for approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV Formulation 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| RSV Formulation 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| RSV Formulation 3 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| RSV Formulation 4 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| RSV Formulation 5 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV vaccine formulation 1 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of any unsolicited systemic adverse events (aes) | Number of participants experiencing immediate AEs | Within 30 minutes after each vaccine injection |
| Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) | Number of participants experiencing solicited injection site reactions | Through 7 days after each vaccine injection |
| Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF) | Number of participants experiencing solicited systemic reactions | Through 7 days after each vaccine injection |
| Presence of unsolicited AEs | Number of participants experiencing unsolicited AEs | Day 1 through day 29 |
| Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) | Number of participants experiencing SAEs and AESIs | Throughout study, approximately 6 months |
| Presence of out-of-range biological test results (including shift from baseline values) | number of participants with out-of-range biological tests | Through 7 days after each vaccine injection |
| RSV A nAb (Neutralizing Antibodies) titers | At day 1 and day 29 |
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Inclusion Criteria:
Aged 18 to 49 years on the day of inclusion
A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site # 0361003 | Wollongong | New South Wales | 2500 | Australia | ||
| Site # 0361006 |
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| Label | URL |
|---|---|
| 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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Investigators, study site staff, laboratory personnel, outcome assessors, and participants will be blinded throughout the study. Study staff preparing and administering the study interventions will be unblinded throughout the study.
| RSV Formulation 6 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| Control group 1 dose 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| Control group 2 dose 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
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| RSV vaccine formulation 2 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 3 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 4 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 5 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 6 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 7 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV vaccine formulation 8 dose | Biological | Suspension for injection. Route of administration: IM injection |
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| Brisbane |
| Queensland |
| 4006 |
| Australia |
| Site # 0361005 | Morayfield | Queensland | 4506 | Australia |
| Site # 0361004 | Southport | Queensland | 4215 | Australia |
| Site # 0361002 | Bayswater | Victoria | 3153 | Australia |
| Site # 0361001 | Camberwell | Victoria | 3124 | 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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