Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RSV, Vaccine
Brief summary
This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
Interventions
BIOLOGICALRESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE
Intramuscular injection
BIOLOGICALHZ/su VACCINE
intramuscular injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions
Exclusion criteria
* Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-confirmed HZ within the past 12 months. * Prior history of any subtype of Guillain Barré syndrome of any etiology. * Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list * Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt of a nonstudy RSV vaccine during study participation. * Previous vaccination with any licensed recombinant adjuvant zoster vaccine (Shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed VZV vaccine (Shingrix) during study participation. * History of previous vaccination with live HZ vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation. * Previous vaccination with any investigational VZV vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational VZV vaccine during study participation. * Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study | Within 4 Months after first study vaccination (Vaccination on Day 1) | Describe SAEs occurring through 4 months after the first study intervention administration. |
| Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone | 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group | — |
| Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone | 1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group | — |
| Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination | Within 7 Days after each vaccination (Vaccination on Day 1) | Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary). |
| Percentage of Participants with Systemic Events Within 7 Days after Vaccination | Within 7 Days after each vaccination (Vaccination on Day 1) | Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary). |
| Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination | Within 1 Month after last vaccination | Describe AEs occurring through 1 month after each study intervention administration |
Secondary
| Measure | Time frame |
|---|---|
| NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT) | Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF |
| NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) | Before vaccination and 1 month after vaccination with RSVpreF |
| NTs for RSV A and RSV B expressed as seroresponse rate | 1 month after vaccination with RSVpreF |
| Anti-gE antibody concentrations expressed as GMCs | Before vaccination and 1 month after the second dose of HZ/su |
| Anti-gE antibody concentrations expressed as GMFRs | Before vaccination and 1 month after the second dose of HZ/su |
| Anti-gE antibody concentrations expressed as seroresponse rate | 1 month after the second dose of HZ/su |
Countries
Puerto Rico, United States
Outcome results
None listed