534 for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)\n- Participants who are healthy as determined by medical evaluation including medical history\n- Born at full term of pregnancy (≥ 37 weeks)"}

Exclusion criteria

• {"criterion_text":"- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n- Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: •\tAny other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration •\tUnless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.\n- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.\n- Receipt of immune globulins, blood or blood-derived products in the past 3 months\n- Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment\n- Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances\n- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n- History of medically diagnosed wheezing\n- Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n- Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.\n- Member of a household that contains an immunocompromised individual, including, but not limited to: •\ta person who is HIV infected •\ta person who has received chemotherapy within the 12 months prior to study enrollment •\ta person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents •\ta person living with a solid organ or bone marrow transplant\n- Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion\n- Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2","definition_or_measurement_approach":"RT-PCR confirmation of RSV associated lower respiratory tract disease (LRTD) assessed during RSV Season 1; event counted if occurring >21 days after dose 2."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2\n- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2\n- Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2\n- Occurrence of urgent care visits, associated with an episode of LRTD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2\n- Occurrence of ARD (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2\n- Occurrence of hospitalizations, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post dose 2\n- Occurrence of urgent care visits, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2\n- Occurrence of LRTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2\n- Occurrence of URTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2\n- Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2\n- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1\n- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1\n- Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1\n- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants\n- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus\n- Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus\n- Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain\n- Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain\n- Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain\n- Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus\n- Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus\n- Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus\n- Presence of solicited administration site reactions within 21 days after each vaccination\n- Presence of solicited systemic reactions within 21 days after each vaccination\n- Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination\n- Presence of unsolicited AEs within 28 days after each vaccination\n- Presence of medically attended adverse events MAAEs throughout the study\n- Presence of serious adverse events (SAEs) throughout the study\n- Presence of adverse events of special interest (AESIs) throughout the study\n- RSV A serum neutralizing antibody titers at D01\n- RSV B serum neutralizing antibody titers at D01\n- RSV A serum neutralizing antibody titers at 28 days post-dose 2\n- RSV B serum neutralizing antibody titers at 28 days post-dose 2\n- RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01\n- RSV serum anti-F IgG ECL antibody titers at D01\n- RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2\n- RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2","definition_or_measurement_approach":"Most efficacy endpoints are RT-PCR confirmed RSV disease events (LRTD/URTD/ARD) assessed during specified RSV seasons; timing reference is >21 days post-dose 1 or post-dose 2 where specified. Safety endpoints include solicited local/systemic reactions (within 21 days), unsolicited AEs (30 minutes and 28 days windows), MAAEs, SAEs and AESIs captured throughout the study. Immunogenicity endpoints are serum neutralizing antibody titers and anti‑F IgA/IgG measured at baseline (D01) and 28 days post-dose 2 using specified assays (e.g., neutralization, ECL) as listed."}

Germany

Earliest CTIS Part Ii Submission Date

08-04-2024

Latest Decision Or Authorization Date

13-05-2024

Processing Time Days

35

Number Of Sites

6

Number Of Participants

90

Spain

Earliest CTIS Part Ii Submission Date

05-04-2024

Latest Decision Or Authorization Date

07-05-2024

Processing Time Days

32

Number Of Sites

5

Number Of Participants

100

Finland

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

30-05-2025

Processing Time Days

413

Number Of Sites

8

Number Of Participants

150

Primary sponsor

Full Name

Sanofi Pasteur Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Limited

Responsibilities

codes:1|13|14|15|2|3|5|6|7|9; includes safety reporting and other sponsor duties (see record)

Name

Azenta US Inc.

Responsibilities

code:4

Third parties

• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"codes:1|13|14|15|2|3|5|6|7|9; note for code 15: Safety Reporting to Ethical Committees, Subject expense reimbursement (Spain only)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}