Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Sanofi

Status and phase: Active, not recruiting; Phase 1

Conditions: RSV Infection; hMPV

Treatments: Biological: RSV/hMPV vaccine dose 2; Biological: RSV/hMPV vaccine dose B2; Biological: RSV/hMPV vaccine dose B1; Biological: RSV/hMPV vaccine dose A3; Biological: Monovalent RSV Vaccine; Biological: RSV/hMPV vaccine dose A1; Biological: RSV/hMPV vaccine dose B3; Biological: RSV/hMPV vaccine dose C3; Biological: RSV/hMPV vaccine dose A2; Biological: RSV/hMPV vaccine dose C1; Biological: RSV/hMPV vaccine dose 1; Biological: RSV/hMPV vaccine dose C2; Biological: RSV/hMPV vaccine dose 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06583031

U1111-1308-3615 (Other Identifier)

VAV00039

Details and patient eligibility

About

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.

Full description

The duration of participation will be approximately 6 months for each participant.

Enrollment: 385 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 60 to 75 years on the day of inclusion
• A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

385 participants in 13 patient groups

Group 1 RSV/hMPV dose A1

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose A1

Group 2 RSV/hMPV dose A2

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose A2

Group 3 RSV/hMPV dose A3

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose A3

Group 4 RSV/hMPV dose B1

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose B1

Group 5 RSV/hMPV dose B2

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose B2

Group 6 RSV/hMPV dose B3

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose B3

Group 7 RSV/hMPV dose C1

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose C1

Group 8 RSV/hMPV dose C2

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose C2

Group 9 RSV/hMPV dose C3

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose C3

Group 10 RSV/hMPV dose 1

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose 1

Group 11 RSV/hMPV dose 2

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose 2

Group 12 RSV/hMPV dose 3

Experimental group

Description:

Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV vaccine dose 3

Group 13 Monovalent RSV Vaccine

Experimental group

Description:

Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.

Treatment:

Biological: Monovalent RSV Vaccine