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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1308-3615 | Other Identifier | WHO UTN |
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VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
The duration of participation will be approximately 6 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 RSV/hMPV dose A1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 2 RSV/hMPV dose A2 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 3 RSV/hMPV dose A3 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 4 RSV/hMPV dose B1 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 5 RSV/hMPV dose B2 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV/hMPV vaccine dose A1 | 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) reported within 30 minutes after vaccination | On Day 1 | |
| Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination | Day 1 through day 8 | |
| Presence of unsolicited AEs reported through 28 days after vaccination | Day 1 through day 29 | |
| Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination | SAE: Screening through day 181; AESI: Day 1 through day 181 | |
| Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination | Screening through day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants | At day 1 and day 29 | |
| hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site # 0361004 | Botany | New South Wales | 2019 | Australia | ||
| Site # 031001 |
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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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Modified double-blinded for the sentinel and main cohorts.
| Group 6 RSV/hMPV dose B3 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 7 RSV/hMPV dose C1 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 8 RSV/hMPV dose C2 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 9 RSV/hMPV dose C3 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 10 RSV/hMPV dose 1 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 11 RSV/hMPV dose 2 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 12 RSV/hMPV dose 3 | Experimental | Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. |
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| Group 13 Monovalent RSV Vaccine | Experimental | Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule. |
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| RSV/hMPV vaccine dose A2 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose A3 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose B1 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose B2 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose B3 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose C1 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose C2 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose C3 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose 1 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose 2 | Biological | Suspension for injection. Route of administration: IM injection |
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| RSV/hMPV vaccine dose 3 | Biological | Suspension for injection. Route of administration: IM injection |
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| Monovalent RSV Vaccine | Biological | Suspension for injection. Route of administration: IM injection |
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| At day 1 and day 28 |
| RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants | At day 1, day 29, day 91, and day 181 |
| RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants | At day 1, day 29, day 91, and day 181 |
| hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine | At day 1, day 29, day 91, and day 181 |
| hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine | At day 1, day 29, day 91, and day 181 |
| Brookvale |
| New South Wales |
| 2100 |
| Australia |
| Site # 0361006 | Miranda | New South Wales | 2228 | Australia |
| Site # 0361002 | Wollongong | New South Wales | 2500 | Australia |
| Site # 0361003 | Herston | Queensland | 4006 | Australia |
| Site # 0361005 | South Brisbane | Queensland | 4101 | 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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