Study: NCT00680914

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 374 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 374 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 374 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 374 at risk

Adverse event: Croup infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 374 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 374 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 374 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 374 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 374 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 374 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 374 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Injection site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 210 affected / 374 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 252 affected / 374 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 182 affected / 374 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 212 affected / 374 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 113 affected / 374 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 293 affected / 374 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 177 affected / 374 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 374 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 374 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 374 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 374 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 374 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 129 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Croup infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 72 affected / 129 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 84 affected / 129 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 69 affected / 129 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 65 affected / 129 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 129 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 99 affected / 129 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 66 affected / 129 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 129 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 129 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 129 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 129 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 129 at risk