Study: NCT02534935

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Cerebellar ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Eustachian tube disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Anisometropia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 30 affected / 44 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Injection site pain (tenderness at injection site)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 35 affected / 44 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 17 affected / 44 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 16 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 44 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 44 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 7 affected / 44 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 44 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 6 affected / 44 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 44 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 44 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 6 affected / 44 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Viral tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 44 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Decreased appetite (loss of appetite)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 22 affected / 44 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Somnolence (drowsiness)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 23 affected / 44 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 44 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 44 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 44 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 31 affected / 44 at risk

Adverse event: Eyelid ptosis
Serious: yes
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Crying
Serious: yes
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Irritability
Serious: yes
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Polydipsia psychogenic
Serious: yes
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Eustachian tube disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 8 affected / 220 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 11 affected / 220 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 8 affected / 220 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 8 affected / 220 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 137 affected / 220 at risk

Adverse event: Injection site pain (tenderness at injection site)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 160 affected / 220 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 103 affected / 220 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 82 affected / 220 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 18 affected / 220 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 22 affected / 220 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 22 affected / 220 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 9 affected / 220 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Exanthema subitum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 10 affected / 220 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 29 affected / 220 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 10 affected / 220 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 27 affected / 220 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 18 affected / 220 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 7 affected / 220 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 8 affected / 220 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 6 affected / 220 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 58 affected / 220 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 7 affected / 220 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 220 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Viral tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 45 affected / 220 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 220 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 220 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Decreased appetite (loss of appetite)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 142 affected / 220 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Somnolence (drowsiness)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 127 affected / 220 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 21 affected / 220 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 8 affected / 220 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 220 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 11 affected / 220 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 220 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 176 affected / 220 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 220 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Accidental exposure to product
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Eustachian tube disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 132 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 132 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 132 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 28 affected / 132 at risk

Adverse event: Injection site pain (tenderness at injection site)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 41 affected / 132 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 20 affected / 132 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 20 affected / 132 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 6 affected / 132 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 11 affected / 132 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 13 affected / 132 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Enterobiasis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 11 affected / 132 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 6 affected / 132 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 132 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 7 affected / 132 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 20 affected / 132 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 15 affected / 132 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 9 affected / 132 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 132 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 34 affected / 132 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 23 affected / 132 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 7 affected / 132 at risk

Adverse event: Decreased appetite (loss of appetite)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 50 affected / 132 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Somnolence (drowsiness)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 40 affected / 132 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 132 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 4 affected / 132 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 132 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 132 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 69 affected / 132 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 132 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 147 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 147 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 71 affected / 147 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 49 affected / 147 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 15 affected / 147 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 147 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 3 affected / 147 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 5 affected / 147 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 147 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 2 affected / 147 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 9 affected / 147 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 68 affected / 147 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 103 affected / 147 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 15 affected / 147 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 24 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 28 affected / 147 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups
Frequency: 8 affected / 147 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 2: 120mcg bivalent rLP2086 (\>=12 months to \<24 months), Group 3: HAV/Saline (\>=12 months to \<24 months); MedDRA v23.0 for booster stage and safety follow up groups.
Frequency: 1 affected / 220 at risk