Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

NCT ID: NCT06251024

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2025-03-11

Brief Summary

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.

The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

Detailed Description

Study duration per participant:

6 months.

Treatment Duration:

1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

Conditions

Respiratory Syncytial Virus Infection; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: RSV vaccine candidate

Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.

Group Type: EXPERIMENTAL

RSV vaccine candidate

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Group 2: placebo

Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Interventions

RSV vaccine candidate

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Intervention Type: BIOLOGICAL

Placebo

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Aged 60 years or older on the day of inclusion
• A female participant is eligible to participate if she is not pregnant or breastfeeding and:

• 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.
• Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.

Exclusion Criteria

• 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)
• Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances ;any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
• History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
• Previous history of myocarditis, pericarditis, and/or myopericarditis
• Thrombocytopenia, contraindicating IM injection based on investigator's judgment
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
• Receipt of any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine in the 4 weeks following any study intervention administration
• Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
• Previous vaccination against RSV with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site Number : 0360003

Botany, New South Wales, Australia

Investigational Site Number : 0360004

Sippy Downs, Queensland, Australia

Investigational Site Number : 0360001

Southport, Queensland, Australia

Investigational Site Number : 0360002

Camberwell, Victoria, Australia

Investigational Site Number : 0360005

Norwood, , Australia

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520006

Concepción, Región del Biobío, Chile

Investigational Site Number : 1520002

Santiago, , Chile

Investigational Site Number : 1520008

Santiago, , Chile

Investigational Site Number : 1700004

Aguazul, , Colombia

Investigational Site Number : 1700002

Barranquilla, , Colombia

Investigational Site Number : 1700006

Bogotá, , Colombia

Investigational Site Number : 1700007

Cali, , Colombia

Investigational Site Number : 1700003

Girardot, , Colombia

Investigational Site Number : 1700005

Ibagué, , Colombia

Investigational Site Number : 1700001

Quindío, , Colombia

Investigational Site Number : 2140001

Santo Domingo, , Dominican Republic

Investigational Site Number : 2140002

Santo Domingo, , Dominican Republic

Investigational Site Number : 3400001

San Pedro Sula, , Honduras

Investigational Site Number : 3400003

Tegucigalpa, , Honduras

Investigational Site Number : 3400002

Tegucugalpa, , Honduras

Investigational Site Number : 4840002

León, Guanajuato, Mexico

Investigational Site Number : 4840003

Querétaro, , Mexico

Countries

Australia; Chile; Colombia; Dominican Republic; Honduras; Mexico

Other Identifiers

U1111-1271-1514

Identifier Type: OTHER

Identifier Source: secondary_id

VAE00017

Identifier Type: OTHER

Identifier Source: secondary_id

VAE00017

Identifier Type: -

Identifier Source: org_study_id