Healthy Volunteers, Respiratory Syncytial Virus Infection
Conditions
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.
Interventions
BIOLOGICALRSV vaccine candidate
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
BIOLOGICALPlacebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
* Investigators, laboratory personnel, sponsor and participants will be blinded * Study staff preparing/administering the study interventions will be unblinded
Intervention model description
Parallel, multi-center, case driven
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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) 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 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 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 |
| 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) |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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 chills |
| 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 |
| Presence of serious adverse events (SAEs) | Throughout study (approximately 6 months) | Number of participants experiencing SAEs |
| Presence of medically attended adverse events (MAAEs) | Throughout study (approximately 6 months) | Number of participants experiencing MAAEs |
| 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 |
| Presence of adverse events of special interest (AESIs) | Throughout study (approximately 6 months) | Number of participants experiencing AESIs |
Countries
Australia, Chile, Colombia, Dominican Republic, Honduras, Mexico
Outcome results
None listed