Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi Pasteur Inc.

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

9 Aug 2024 → 15 May 2026

Decision date (initial)

2024-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi Pasteur Inc

External identifiers

EU CT number

2023-505762-29-00

WHO UTN

U1111-1280-7192

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Prophylaxis, Efficacy, Others

To demonstrate the clinical efficacy of RSVt vaccine for the prevention of reverse transcription polymerase chain reaction (RT PCR) confirmed RSV lower respiratory tract disease (LRTD) after 2 doses, over RSV Season 1

Secondary objectives 24

1. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV upper respiratory tract disease (URTD) after 2 doses over RSV Season 1
2. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV associated with the occurrence of LRTD, leading to hospitalization after 2 doses over RSV Season 1
3. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV severe LRTD after 2 doses over RSV Season 1
4. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 1, necessitating urgent care
5. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV ARD after 2 doses over RSV Season 1
6. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 1, leading to hospitalization
7. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 1, necessitating urgent care
8. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD, by RSV strain after 2 doses over RSV Season 1
9. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD, by RSV strain after 2 doses over RSV Season 1
10. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD, by RSV strain after 2 doses over RSV Season 1
11. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV LRTD after at least one dose, over RSV Season 1
12. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV URTD after at least one dose, over RSV Season 1
13. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV ARD after at least one dose, over RSV Season 1
14. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV LRTD after 2 doses over RSV Season 1, in RSV-exposed participants
15. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV URTD after 2 doses over RSV Season 1, by baseline serostatus
16. To describe the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV ARD after 2 doses over RSV Season 1, by baseline serostatus
17. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 2
18. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after 2 doses over RSV Season 2
19. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 2
20. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses over RSV Season 2, by baseline serostatus
21. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV URTD after 2 doses over RSV Season 2, by baseline serostatus
22. To describe the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV ARD after 2 doses over RSV Season 2, by baseline serostatus
23. To describe the safety profile of the RSVt vaccine
24. To describe the RSV A and B serum neutralizing and RSV serum anti-F IgA and IgG antibody responses to the study intervention

Conditions and MedDRA coding

Virus diseases

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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)
2. Participants who are healthy as determined by medical evaluation including medical history
3. Born at full term of pregnancy (≥ 37 weeks)

Exclusion criteria 14

1. 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)
2. 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
3. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
4. History of medically diagnosed wheezing
5. 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.
6. 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.
7. Member of a household that contains an immunocompromised individual, including, but not limited to: • a person who is HIV infected • a person who has received chemotherapy within the 12 months prior to study enrollment • a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents • a person living with a solid organ or bone marrow transplant
8. Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion
9. Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
10. Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration • Unless 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.
11. 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.
12. Receipt of immune globulins, blood or blood-derived products in the past 3 months
13. Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
14. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2

Secondary endpoints 37

1. Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
2. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2
3. Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
4. 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
5. Occurrence of ARD (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
6. 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
7. 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
8. Occurrence of LRTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
9. Occurrence of URTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
10. Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2
11. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
12. Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
13. Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
14. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants
15. Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
16. Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
17. Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
18. Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
19. Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain
20. Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
21. Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
22. Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
23. Presence of solicited administration site reactions within 21 days after each vaccination
24. Presence of solicited systemic reactions within 21 days after each vaccination
25. Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
26. Presence of unsolicited AEs within 28 days after each vaccination
27. Presence of medically attended adverse events MAAEs throughout the study
28. Presence of serious adverse events (SAEs) throughout the study
29. Presence of adverse events of special interest (AESIs) throughout the study
30. RSV A serum neutralizing antibody titers at D01
31. RSV B serum neutralizing antibody titers at D01
32. RSV A serum neutralizing antibody titers at 28 days post-dose 2
33. RSV B serum neutralizing antibody titers at 28 days post-dose 2
34. RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01
35. RSV serum anti-F IgG ECL antibody titers at D01
36. RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2
37. RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi Pasteur Inc.

Sponsor organisation

Sanofi Pasteur Inc.

Address

1 Discovery Drive

City

Swiftwater

Postcode

18370-9100

Country

United States

Scientific contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Third parties 3

Locations

3 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications