Phase 3, Placebo-Controlled, Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Trial of a 6-Valent OspA-Based Lyme Disease Vaccine

INTERVENTION: Product Name: PF‐07307405 (180µg/dose) Product Code: VLA15 Pharmaceutical Form: Suspension for injection in pre‐filled syringe INN or Proposed INN: Lip‐D1B2B Current Sponsor code: Lip‐D1B2B Other descriptive name: Borrelia burgdorferi, serotype 1, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 2, Outer Surface Protein A Concentration unit: µl/ml microlitre(s)/millilitre Concentration type: equal Concentration number: 120‐ INN or Proposed INN: Lip‐D4Bva3B Current Sponsor code: Lip‐D4Bva3B Other descriptive name: Borrelia burgdorferi, serotype 3, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 4, Outer surface protein A Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ INN or Proposed INN: Lip‐D5B6B Current Sponsor code: Lip‐D5B6B Other descriptive name: Borrelia burgdorferi, serotype 5, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 6, Outer surface protein A Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] Prevention of Lyme disease caused by Borrelia species in individuals =5 years of age by active immunization ; MedDRA version: 20.0 Level: PT Classification code 10025169 Term: Lyme disease System Organ Class: 10021881 ‐ Infections and infestations PRIMARY OUTCOME: Primary end point(s): Primary Efficacy; 1. Clinically‐ and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato.; 2.Clinically‐ and laboratory‐confirmed Lyme disease caused by B burgdorferi sensu lato.; Primary Safety; 1.; •Prompted local reactions (pain at the injection site, redness, and swelling).; •Prompted systemic events (fever, headache, fatigue, muscle pain, and joint pain).; •AEs.; •NDCMCs.; •SAEs.; Primary Immunogenicity (Lot‐Consistency Subset); 1. Anti‐OspA quantitative immunological assay titer. Timepoint(s) of evaluation of this end point: Timepoints described in detail in the Protocol Secondary Objective: Secondary Efficacy; •To describe the efficacy of VLA15 in reducing otherwise‐undiagnosed Lyme disease seroconversion after each season.; • To describe the efficacy of VLA15 in preventing confirmed Lyme disease by geographic region (NA and Europe separately). Main Objective: Primary Efficacy; 1. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination. ; 2. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose.; Primary Safety; 1.To describe the safety profile of VLA15 as measured by the percentage of participants reporting local reactions, systemic events, AEs, NDCMCs, and SAEs.; Primary Immunogenicity (Lot‐Consistency Subset); 1.To demonstrate that the immune responses to the 6 serotypes induced by VLA15 are equivalent across 3 independent lots. SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: Timepoints described in detail in the Protocol Secondary end point(s): Secondary Efficacy; 1. Otherwise‐undiagnosed cases of Lyme disease; 2.Clinically‐ and laboratory‐confirmed Lyme disease caused by B burgdorferi sensu lato. INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1.Male or female participants =5 years of age at enrollment (signing of ICD or assent) in all countries where pediatric enrollment is permitted. In countries or sites where enrollment of children is not permitted, male or female participants =18 years of age at the time of informed consent. • Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Type of Participant and Disease Characteristics: 2.Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to: •Individuals who work in B burgdorferi–infected/tick‐infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wil