Study: NCT00439335

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Insulin-requiring type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 113 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 13 affected / 113 at risk

Adverse event: Injection site exfoliation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 113 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 113 affected / 113 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 113 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 113 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 113 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 113 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site induration (size) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site induration (size) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site induration (functional grading) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site induration (functional grading) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 113 affected / 113 at risk

Adverse event: Injection site discolouration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 37 affected / 113 at risk

Adverse event: Injection site discolouration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 63 affected / 113 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at vaccination site"
Frequency: 80 affected / 113 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at vaccination site"
Frequency: 83 affected / 113 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 18 affected / 113 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 10 affected / 113 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 83 affected / 113 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 76 affected / 113 at risk

Adverse event: Feeling hot - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 8 affected / 113 at risk

Adverse event: Feeling hot - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 6 affected / 113 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the memory aid as "Headache"
Frequency: 41 affected / 113 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the memory aid as "Headache"
Frequency: 28 affected / 113 at risk

Adverse event: Malaise - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Malaise(decreased energy)"
Frequency: 32 affected / 113 at risk

Adverse event: Malaise - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Malaise(decreased energy)"
Frequency: 19 affected / 113 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Myalgia - (body aches not at injection site)"
Frequency: 15 affected / 113 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Myalgia - (body aches not at injection site)"
Frequency: 8 affected / 113 at risk

Adverse event: Nausea - post dose 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the memory aid as "Nausea"
Frequency: 9 affected / 113 at risk

Adverse event: Nausea - post dose 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the memory aid as "Nausea"
Frequency: 7 affected / 113 at risk

Adverse event: Injection site erythema, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 35 affected / 113 at risk

Adverse event: Injection site erythema, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 46 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (size) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 16 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (size) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 37 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (functional grading) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 15 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (functional grading) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 37 affected / 113 at risk

Adverse event: Injection site discolouration, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 1 affected / 113 at risk

Adverse event: Injection site discolouration, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 55 affected / 113 at risk

Adverse event: Injection site pain, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 14 affected / 113 at risk

Adverse event: Injection site pain, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 16 affected / 113 at risk

Adverse event: Tenderness, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 30 affected / 113 at risk

Adverse event: Tenderness, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 28 affected / 113 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 13 affected / 114 at risk

Adverse event: Injection site exfoliation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 9 affected / 114 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 114 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 114 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 114 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 42 affected / 114 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 42 affected / 113 at risk

Adverse event: Injection site induration (size) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 20 affected / 114 at risk

Adverse event: Injection site induration (size) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 23 affected / 113 at risk

Adverse event: Injection site induration (functional grading) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 20 affected / 114 at risk

Adverse event: Injection site induration (functional grading) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 24 affected / 113 at risk

Adverse event: Injection site discolouration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 2 affected / 114 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at vaccination site"
Frequency: 3 affected / 114 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Itchiness at vaccination site"
Frequency: 7 affected / 113 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 37 affected / 114 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 39 affected / 113 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 79 affected / 114 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 67 affected / 113 at risk

Adverse event: Feeling hot - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 7 affected / 114 at risk

Adverse event: Feeling hot - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Feverishness"
Frequency: 8 affected / 113 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the memory aid as "Headache"
Frequency: 36 affected / 114 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the memory aid as "Headache"
Frequency: 20 affected / 114 at risk

Adverse event: Malaise - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Malaise(decreased energy)"
Frequency: 33 affected / 114 at risk

Adverse event: Malaise - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Malaise(decreased energy)"
Frequency: 19 affected / 113 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Myalgia - (body aches not at injection site)"
Frequency: 21 affected / 114 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the memory aid as "Myalgia - (body aches not at injection site)"
Frequency: 7 affected / 113 at risk

Adverse event: Nausea - post dose 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the memory aid as "Nausea"
Frequency: 9 affected / 114 at risk

Adverse event: Nausea - post dose 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the memory aid as "Nausea"
Frequency: 4 affected / 113 at risk

Adverse event: Injection site erythema, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 55 affected / 114 at risk

Adverse event: Injection site erythema, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Erythema (redness)" and measured in millimeters.
Frequency: 60 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (size) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 112 affected / 114 at risk

Adverse event: Injection site induration, placebo arm - (size) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" and measured in millimeters.
Frequency: 111 affected / 113 at risk

Adverse event: Injection site induration, placebo arm - (functional grading) - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 113 affected / 114 at risk

Adverse event: Injection site induration, placebo arm - (functional grading) - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Induration (swelling)" with grading based on impact on daily activities.
Frequency: 110 affected / 113 at risk

Adverse event: Injection site discolouration, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 7 affected / 114 at risk

Adverse event: Injection site discolouration, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pigmentation (discoloration)" and measured in millimeters.
Frequency: 3 affected / 113 at risk

Adverse event: Injection site pain, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 7 affected / 114 at risk

Adverse event: Injection site pain, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Pain at injection site at rest"
Frequency: 12 affected / 113 at risk

Adverse event: Tenderness, placebo arm - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 16 affected / 114 at risk

Adverse event: Tenderness, placebo arm - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the memory aid as "Tenderness at injection site with movement/touch"
Frequency: 21 affected / 113 at risk