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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1322-6386 | Other Identifier | WHO UTN |
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The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years.
The total duration of study participation for each participant varies by stage and treatment arm.
Stage 1:
Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1, Arm 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 1, Arm 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 1, Arm 3 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 1, Arm 4 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
|
| Stage 1, Arm 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 |
|---|---|---|---|---|
| H5 Flu Investigational Medical Product (IMP) 1 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
|
| 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 reactions (ie, injection site pain, injection site erythema, injection site swelling, pre-listed in participant's diary and in the eCRF (electronic case report form)) occurring through 7 days after each vaccination | Day 1 through day 8 | |
| Presence of solicited systemic reactions (ie, fever, headache, and only new or worsened fatigue, myalgia, arthralgia, and chills pre-listed in the participant's diary and in the eCRF) occurring through 7 days after each vaccination | Day 1 through day 8 | |
| Presence of unsolicited AEs reported through 20 days after the first vaccination and after the second vaccination for IMPs with the Flu H5 antigen | Day 1 through day 21 | |
| Presence of unsolicited AEs reported through 28 days after vaccination for IMPs with the RSV antigen | 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 day through day 202 (IMPs containing Flu H5 antigen), Screening day through day 181 (IMPs containing RSV antigen); AESI: Day 1 through day 202 (IMPs containing Flu H5 antigen), Day 1 through day 181 (IMPs containing RSV antigen) | |
| Presence of out-of-range biological test results (including shift from baseline values) through 7 days after each vaccination | Screening through day 8 | |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean neutralizing antibody titers measured by Neutralization Assay (NT) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 | |
| Neutralizing antibody titer ratio at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen |
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Inclusion Criteria:
Exclusion Criteria:
• 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanofi Trial Transparency Email Recommended (Toll free for US and Canada) | Contact | 800-633-1610 | Opt. 6 | contact-us@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site # 0361002 | Recruiting | Griffith | Queensland | 4222 | Australia | |
| Site # 0361001 |
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 design for Sentinel and Main Cohorts.
| Stage 1, Arm 6 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
|
| Stage 2, Arm 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 2, Arm 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
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| Stage 2, Arm 3 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
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| Stage 2, Arm 4 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 2, Arm 5 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| Stage 2, Arm 6 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
|
| H5 Flu IMP 2 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 3 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| RSV IMP 4 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| RSV IMP 5 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| RSV IMP 6 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 7 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 8 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 9 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 10 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
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| H5 Flu IMP 11 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
|
| H5 Flu IMP 12 | Biological | Suspension for injection. Route of administration: Intramuscular (IM) injection |
|
| Presence of AEs leading to study discontinuation throughout the study (ie, through 6 months after vaccination) |
| Screening through day 202 (IMPs containing Flu H5 antigen), Screening through day 181 (IMPs containing RSV antigen) |
| RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants receiving IMPs with the RSV antigen | Day 1 and day 29 |
| Flu H5 antibody (Ab) titer measured by hemagglutination inhibition (HAI) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22 and day 43 |
| Hemagglutination Inhibition (HAI) geometric mean titer ratio at 21 and 42 days post-vaccination relative to pre-vaccination for all participants receiving IMPs with the Flu H5 antigen | Ratio of post-vaccination to pre-vaccination hemagglutination inhibition (HAI) antibody titers, calculated as Day 22/Day 1 and Day 43/Day 1. | Day 1, day 22 and day 43 |
| Seroconversion rate based on Hemagglutination inhibition (HAI) antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22 and day 43 |
| Proportion of participants with Hemagglutination Inhibition (HAI) antibody titer ≥40 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 |
| Proportion of participants with detectable HAI antibody titer ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 |
Ratio of post-vaccination to pre-vaccination neutralizing antibody titers, calculated as Day 22/Day 1 and Day 43/Day 1 using a validated neutralization (NT) assay. |
| Day 1, day 22, and day 43 |
| Proportion of participants with neutralizing antibody titers ≥20, ≥40, and ≥80 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 |
| Proportion of participants with detectable neutralizing antibody titers ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 |
| Proportion of participants with ≥2-fold and ≥4-fold increase in neutralizing antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 |
| Recruiting |
| Herston |
| Queensland |
| 4006 |
| Australia |
| Site # 0361003 | Recruiting | Morayfield | Queensland | 4506 | Australia |
| Site # 0361005 | Recruiting | Sippy Downs | Queensland | 4556 | Australia |
| Site # 03610004 | Recruiting | South Brisbane | Queensland | 4104 | Australia |
| Site # 036006 | Recruiting | Taringa | Queensland | 4068 | Australia |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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