Lower Respiratory Tract Illness
Conditions
Interventions
Biological: RSVpreF
RSV vaccine (RSVpreF)
Biological: Placebo
Placebo
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated. 2.Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol. 3.Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. 4.Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. 5.Male or female participants >=60 years of age. *Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration. *Female participants must not be of childbearing potential.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1.Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 2.History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine. 3.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. 4.Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 5.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 6. Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3). Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 12 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study 7.Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone. 8.Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration. 9.Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. 10.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : 1.Number of first episode of RSV-associated moderate to severe lower respiratory tract illness (msLRTI-RSV) in the first RSV season [ Time Frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months) ] Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. 2.Proportion of participants reporting prompted local reactions within 7-days after vaccination [ Time Frame: Within 7 days after vaccination ] Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity 3.Proportion of participants reporting prompted systemic events within 7-days after vaccination [ Time Frame: Within 7 days after vaccination ] Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of first episode of msLRTI-RSV in the second RSV season [ Time Frame: During the second RSV season (an average of 6 months) ] 2.Number of first episode of msLRTI-RSV in the third RSV season [ Time Frame: During the third RSV season (an average of 6 months) ] 3.Number of first episode of msLRTI-RSV through first 2 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance) ] 4.Number of first episode of msLRTI-RSV across 3 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 3 visit (an average of 18 months of surveillance) ] 1 to 4: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. msLRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. 5.Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season [ Time Frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months) ] 6.Number of first episode of ARI-RSV in the second RSV season [ Time Frame: During the second RSV season (an average of 6 months) ] 7.Number of first episode of ARI-RSV in the third RSV season [ Time Frame: During the third RSV season (an average of 6 months) ] 8.Number of first episode of ARI-RSV through first 2 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance) ] 9.Number of first episode of ARI-RSV across 3 RSV seasons [ Time Frame: From Day 15 after vaccination until the end of season 3 visit (an average of 18 months of surveillance) ] 5 to 9: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least | — |
Countries
Japan, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed