A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy

Key Inclusion Criteria:

• Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy;

• Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specificantibody per litre (kUA/L) at screening;

• Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater thannegative control at screening;

• Positive peanut double blind placebo-controlled food challenge (DBPCFC) with areactive dose ≤300 mg peanut protein (≤443 mg cumulative reactive dose [CRD]);

• Able to perform spirometry or peak expiratory flow. Children who are 4 years of ageat Screening Stage 1 visit and unable to perform peak expiratory may be enrolledproviding they had no clinical features of moderate or severe persistent asthmawithin 1 year prior to the Screening visit;

• Forced expiratory volume in 1 second (FEV1) ≥80% predicted in adolescents andchildren with asthma capable of performing spirometry, or peak expiratory flow ≥80%predicted in participants with asthma unable to perform spirometry (atinvestigator's discretion).

Key Exclusion Criteria:

• History of or current clinically significant medical conditions or laboratoryabnormalities which in the opinion of the investigator would jeopardise the safetyof the participant or the validity of the study results;

• Severe or unstable asthma as assessed by the Global Initiative for Asthma (GINA)assessment of asthma control OR current treatment for asthma at GINA ≥Step 4 level;

• Participants with skin disorders that would hinder skin prick testing and/or itsinterpretation or study drug administration (eg, severe generalised poorlycontrollable atopic dermatitis);

• Any medical condition in which epinephrine (adrenaline) is contraindicated;

• Prior therapy aimed at desensitising peanut allergy, either in a formal study or inclinical practice;

• Severe or life-threatening reaction during the screening food challenge, atinvestigator discretion.