Study: NCT00831311

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 311 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 311 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 311 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 311 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 311 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 311 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 311 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 311 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 311 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 311 at risk

Adverse event: Injection Site Erythemia
Serious: no
Organ System: General disorders
Frequency: 213 affected / 311 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 215 affected / 311 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 172 affected / 311 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 242 affected / 311 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 209 affected / 311 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: General disorders
Frequency: 24 affected / 311 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 311 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 146 affected / 311 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 195 affected / 311 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 197 affected / 311 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 218 affected / 311 at risk

Adverse event: Bronchitis Not Otherwise Specified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 311 at risk

Adverse event: Rhinitis Not Otherwise Specified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 311 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 312 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 312 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 312 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 312 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 312 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 312 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 312 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 312 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 312 at risk

Adverse event: Injection Site Erythemia
Serious: no
Organ System: General disorders
Frequency: 194 affected / 312 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 186 affected / 312 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 140 affected / 312 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 202 affected / 312 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 177 affected / 312 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: General disorders
Frequency: 27 affected / 312 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 312 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 138 affected / 312 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 156 affected / 312 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 178 affected / 312 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 193 affected / 312 at risk

Adverse event: Bronchitis Not Otherwise Specified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 312 at risk

Adverse event: Rhinitis Not Otherwise Specified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 312 at risk