Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

Sanofi

Status and phase: Enrolling; Phase 1

Conditions: Metapneumovirus Infection; Respiratory Syncytial Virus Infection; Parainfluenzae Virus Infection

Treatments: Biological: RSV/hMPV vaccine; Biological: RSV/hMPV/PIV3 vaccine; Biological: RSV vaccine 2; Biological: RSV vaccine 1; Biological: parainfluenza virus type 3 vaccine (PIV3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06604767

VBD00006

U1111-1304-9362 (Registry Identifier)

Details and patient eligibility

About

The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.

Full description

The study duration will be up to approximately 12 months minus the screening period.

Enrollment: 390 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
• Informed consent form (ICF) has been signed and dated
• A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Note: 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

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390 participants in 9 patient groups

PIV3 Dose 1

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 2

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 3

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 4

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: parainfluenza virus type 3 vaccine (PIV3)

RSV/hMPV /PIV3 Formulation 1

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: RSV/hMPV/PIV3 vaccine

RSV/hMPV Formulation 1

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: RSV/hMPV vaccine

RSV/hMPV Formulation 2

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: RSV/hMPV vaccine

RSV vaccine 1

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: RSV vaccine 1

RSV vaccine 2

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection at Day 1

Treatment:

Biological: RSV vaccine 2