Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

Exclusion Criteria

• •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• •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.
• •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.
• •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.
• •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 6 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 - 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.
• •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
• •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.
• •Substudy A
• •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• •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.
• •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.
• •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.
• •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 103).
• •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 6 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
• •\- 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.
• •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
• •Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy A.
• •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.
• •Participant was confirmed by the sponsor to have previously received the study intervention more than once.
• •Substudy B
• •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• •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.
• •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.
• •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.
• •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 203).
• •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 6 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 - 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.
• •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
• •Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy B.
• •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.
• •Participant was confirmed by the sponsor to have previously received the study intervention more than once.
• •Participants who completed Vaccination 1 from the efficacy study less than 9 months or greater than 15 months prior to revaccination.
• •Substudy C
• •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• •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.
• •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.
• •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.
• •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 303 or Visit 306).
• •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 6 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
• •\- 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.
• •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
• •Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy C.
• •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.
• •Participant was confirmed by the sponsor to have previously received the study intervention more than once.
• •Prior history of any subtype of Guillain-Barré syndrome of any etiology.
• •Current or prior participation in Substudy A or Substudy B.
• •Participants who completed Vaccination 1 from the efficacy study less than 32 months or greater than 40 months prior to revaccination.