Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older
- Conditions
- Respiratory Syncytial Virus InfectionHealthy Volunteers
- Interventions
- Biological: PlaceboBiological: RSV vaccine candidate
- Registration Number
- NCT06251024
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4541
-
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.
Participants are excluded from the study if any of the following criteria apply:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: placebo Placebo Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo. Group 1: RSV vaccine candidate RSV vaccine candidate Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.
- Primary Outcome Measures
Name Time Method Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
- Secondary Outcome Measures
Name Time Method Presence of hospitalization due to RSV-ARD and/or RSV-LRTD ≥ 14 days after vaccination Number of participants hospitalized due to RSV-ARD and/or RSV-LRTD
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination ≥ 14 days after vaccination Number of participants experiencing RSV-MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination ≥ 14 days after vaccination Number of participants experiencing RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV B) ≥ 14 days after vaccination
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset Day 1 and Day 29 RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination ≥ 14 days after vaccination Number of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one)
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset Month 6 RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Presence of solicited injection site or systemic reactions Within 7 days after primary vaccination Number of participants reporting:
* injection site reactions: pain, erythema and swelling
* systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chillsPresence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination) ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV A) ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities ≥ 14 days after vaccination Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset Month 6 Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
Presence of unsolicited immediate systemic adverse events (AEs) Within 30 minutes after primary vaccination Number of participants experiencing an unsolicited immediate systemic adverse event
Presence of unsolicited AEs Within 28 days after primary vaccination Number of participants experiencing unsolicited AEs
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B) ≥ 14 days after vaccination Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B) ≥ 14 days after vaccination Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset Day 1 and Day 29 RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset Day 1 and Day 29 Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Presence of serious adverse events (SAEs) Throughout study (approximately 6 months) Number of participants experiencing SAEs
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset Month 6 RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Presence of medically attended adverse events (MAAEs) Throughout study (approximately 6 months) Number of participants experiencing MAAEs
Presence of adverse events of special interest (AESIs) Throughout study (approximately 6 months) Number of participants experiencing AESIs
Trial Locations
- Locations (25)
Investigational Site Number : 4840002
🇲🇽Leon, Guanajuato, Mexico
Investigational Site Number : 1700001
🇨🇴Quindio, 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 : 0360003
🇦🇺Botany, New South Wales, Australia
Investigational Site Number : 0360004
🇦🇺Sippy Downs, Queensland, Australia
Investigational Site Number : 3400002
🇭🇳Tegucugalpa, Honduras
Investigational Site Number : 4840003
🇲🇽Queretaro, Mexico
Investigational Site Number : 0360001
🇦🇺Southport, Queensland, Australia
Investigational Site Number : 0360002
🇦🇺Camberwell, Victoria, Australia
Investigational Site Number : 0360005
🇦🇺Norwood, Australia
Investigational Site Number : 1520006
🇨🇱Concepcion, Biobío, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520004
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002
🇨🇱Santiago, Chile
Investigational Site Number : 1520008
🇨🇱Santiago, Chile
Investigational Site Number : 1520005
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1700004
🇨🇴Aguazul, Colombia
Investigational Site Number : 1700002
🇨🇴Barranquilla, Colombia
Investigational Site Number : 1700006
🇨🇴Bogota, Colombia
Investigational Site Number : 1700007
🇨🇴Cali, Colombia
Investigational Site Number : 1700003
🇨🇴Girardot, Colombia
Investigational Site Number : 1700005
🇨🇴Ibague, Colombia