Study: NCT00197028

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 107 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 107 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 107 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pyoderma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Bronchial hyper reactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 107 affected / 107 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 39 affected / 107 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 64 affected / 107 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 24 affected / 107 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 89 affected / 107 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 58 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 26 affected / 107 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 13 affected / 107 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 14 affected / 107 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 7 affected / 107 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 11 affected / 107 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: During the 14-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 7 affected / 107 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 17 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-BTM vaccine
Frequency: 21 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-BTM vaccine
Frequency: 7 affected / 97 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 3 affected / 105 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 5 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 8 affected / 105 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 6 affected / 97 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 105 affected / 105 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 26 affected / 105 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 60 affected / 105 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 25 affected / 105 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 81 affected / 105 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 53 affected / 105 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 3 affected / 107 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 107 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 107 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 107 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 107 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pyoderma
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Ascariasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Tinea capitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 107 affected / 107 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 47 affected / 107 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 58 affected / 107 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 25 affected / 107 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 88 affected / 107 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 49 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 18 affected / 107 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 10 affected / 107 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 7 affected / 107 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 5 affected / 107 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 4 affected / 107 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: During the 14-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 2 affected / 107 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 6 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-BTM vaccine
Frequency: 24 affected / 106 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-BTM vaccine
Frequency: 15 affected / 97 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 7 affected / 106 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 3 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 8 affected / 106 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
Frequency: 6 affected / 97 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 105 affected / 106 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 23 affected / 106 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 69 affected / 106 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 23 affected / 106 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 81 affected / 106 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 62 affected / 106 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Notes: During the 30-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
Frequency: 7 affected / 97 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
Frequency: 6 affected / 107 at risk