Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults \>=60 years of age
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20,419
One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.
One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms
RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms
RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of PCR Confirmed RSV-associated ARD
RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of Complications Related to PCR-confirmed RSV Disease
RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
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North Alabama Research Center, LLC
Athens, Alabama, United States
Central Alabama Research
Birmingham, Alabama, United States
Achieve Clinical Research, LLC d/b/a Accel Research Sites
Birmingham, Alabama, United States
Medical Affiliation Research Center
Huntsville, Alabama, United States
Lenzmeier Family Medicine / CCT Research
Glendale, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
Pain Center of Arizona
Phoenix, Arizona, United States
Cognitive Clinical Trials, LLC
Phoenix, Arizona, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States
...and 110 more locations
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease
Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of Severe PCR Confirmed RSV-associated LRTD
Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation \<92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate \>25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia
Time frame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Number of Participants With Serious Adverse Events
Number and percentage of study participants reporting any serious adverse events at any time during the trial period.
Time frame: From vaccination through study termination, up to 16 months
Number of Participants With Grade 3 or Higher Adverse Events
Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine
Time frame: Within 29 days after vaccination
Number of Participants With Solicited Local Adverse Events
Number and percentage of study participants reporting injection site reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Time frame: Within 8 days after vaccination
Number of Participants With Solicited Systemic Adverse Events
Number and percentage of study participants reporting systemic reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Time frame: Within 8 days after vaccination
Number of Participants With Unsolicited Adverse Events
Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.
Time frame: Within 29 days after vaccination
RSV-specific T-cell Responses
RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population
Time frame: 1 week after vaccination
RSV-specific Serum IgG Antibody Titers
Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: 2 weeks after vaccination
RSV-specific Serum Neutralizing Antibody Titers (Subtype A)
Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ
Time frame: 2 weeks after vaccination
RSV-specific Serum Neutralizing Antibody Titers (Subtype B)
Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ
Time frame: 2 weeks after vaccination