Study: NCT01310413

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 2 affected / 607 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group..
Frequency: 1 affected / 607 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Skeletal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 607 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 405 affected / 603 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 41 affected / 603 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 101 affected / 294 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 128 affected / 294 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 79 affected / 294 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 59 affected / 294 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 89 affected / 309 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 43 affected / 309 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 100 affected / 309 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 50 affected / 309 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 123 affected / 309 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 25 affected / 309 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 25 affected / 309 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 19 affected / 309 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 36 affected / 607 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 29 affected / 607 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 27 affected / 607 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 13 affected / 607 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 231 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 231 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 231 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 231 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 69 affected / 229 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 229 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 29 affected / 122 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 40 affected / 122 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 29 affected / 122 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 21 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 19 affected / 107 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 18 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 18 affected / 107 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 9 affected / 107 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 17 affected / 107 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 7 affected / 107 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 4 affected / 107 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 3 affected / 107 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 17 affected / 231 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 18 affected / 231 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 13 affected / 231 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 12 affected / 231 at risk

Adverse event: Scarlet fever
Serious: yes
Organ System: Infections and infestations
Notes: SAE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 155 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U385 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 155 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 111 affected / 154 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: AE assesed during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 5 affected / 154 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 23 affected / 79 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 28 affected / 79 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 18 affected / 79 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children less than 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 4 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 18 affected / 75 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 7 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 24 affected / 75 at risk

Adverse event: Joint pain at other location
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 14 affected / 75 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 34 affected / 75 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 7 affected / 75 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 5 affected / 75 at risk

Adverse event: Fever (axillary temperature >= 38.0°C)
Serious: no
Organ System: General disorders
Notes: AE assesed in children at least 6 years of age during Day 0 to Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 1 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 9 affected / 155 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 10 affected / 155 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 3 affected / 155 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE assesed within the 42-day post-vaccination period following the first vaccination during Day 0 - Day 385 for Influenza A (H5N1) adjuvanted and Placebo Groups and from Day U0 to U42 for the Placebo/Influenza A (H5N1) adjuvanted Group.
Frequency: 3 affected / 155 at risk