A Phase 3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults

INTERVENTION: Product Name: PF‐06928316 (RSV vaccine, 120µg/dose) Product Code: PF‐06928316 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: PF‐06928316 (847B) Current Sponsor code: 847B DS Other descriptive name: PF‐06928316 (847B) Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ INN or Proposed INN: PF‐06928316 (847A) Current Sponsor code: 847A DS Other descriptive name: PF‐06928316 (847A) Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Prevention of RSV‐associated moderate to severe lower respiratory tract illness in adults 60 years of age and older by active immunization ; MedDRA version: 21.1 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 100000004865 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] SECONDARY OUTCOME: Secondary end point(s): Secondary Efficacy; a,b) msLRTI‐RSV cases; c) ARI‐RSV cases; d) sLRTI‐RSV cases; Secondary Immunogenicity; ‐RSV NT; ‐RSVpreF‐binding IgG; Timepoint(s) of evaluation of this end point: Secondary Efficacy ‐ Timepoints described in detail in the Protocol; Secondary Immunogenicity ‐ Timepoints described in detail in the Protocol; 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 Section 10.8. 3.Adults who are ambulatory and live in the community, or in assisted living or long‐term care residential facilities that provide minimal PRIMARY OUTCOME: Main Objective: Primary Efficacy: To demonstrate the efficacy of RSVpreF in preventing RSV‐associated moderate to severe lower respiratory tract illness (msLRTI‐RSV) RSV in the first RSV season following vaccination.; Primary Safety: To describe the safety profile of RSVpreF as measured by the percentage of participants reporting local reactions, systemic events, AEs, and SAEs. Primary end point(s): Primary Efficacy: msLRTI‐RSV cases.; Primary Safety:; •Prompted local reactions (pain at the injection site, redness, and swelling).; •Prompted systemic events (fever, nausea, diarrhea, vomiting, headache, fatigue, muscle pain, and joint pain).; •AEs.; •Newly diagnosed chronic medical conditions (NDCMCs); •SAEs.; Secondary Objective: Secondary Efficacy: ; a) To describe the efficacy of RSVpreF in preventing msLRTI‐RSV across multiple RSV seasons following vaccination.; b) To describe the efficacy of RSVpreF in preventing msLRTI‐RSV in the second and third RSV seasons.; c) To describe the efficacy of RSVpreF in preventing RSV‐associated acute respiratory illness (ARI‐RSV) at each RSV season and across multiple RSV seasons following vaccination.; d) To describe the efficacy of RSVpreF in preventing RSV‐associated severe lower respiratory tract illness (sLRTI‐RSV) at each RSV season and across multiple RSV seasons following vaccination; Secondary Immunogenicity: To describe the immune responses induced by RSVpreF following vaccination. Timepoint(s) of evaluation of this end point: Efficacy: vaccine efficacy (VE), defined as the relative risk reduction of 1st episode msLRTI‐RSV cases in the RSVpreF group compared to the placebo group in the 1st RSV season (from D15) and in compliance with the key protocol criteria ; Safety:in participants receiving at least 1 dose of intervention; ‐The % of participants reporting prompted local reactions within 7 days following study intervention administration in a subset of participants; ‐The % of participants r‐ing prompted systemic events within 7 days following study intervention administration in a subset of participants; ‐The % of participants r‐ing AEs through 1 month following study intervention administration; ‐The % of participants r‐ing NDCMCs throughout the study; ‐The % of participants r‐ing SAEs throughout the study;