Study: NCT01035749

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pain (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the primary phase of the study
Frequency: 52 affected / 66 at risk

Adverse event: Swelling (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study
Frequency: 6 affected / 66 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 4 affected / 65 at risk

Adverse event: Arthralgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 13 affected / 65 at risk

Adverse event: Fatigue (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 29 affected / 65 at risk

Adverse event: Headache (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 27 affected / 66 at risk

Adverse event: Myalgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 19 affected / 65 at risk

Adverse event: Shivering (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 6 affected / 66 at risk

Adverse event: Sweating (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 6 affected / 66 at risk

Adverse event: Pain (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study
Frequency: 48 affected / 65 at risk

Adverse event: Swelling (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 6 affected / 65 at risk

Adverse event: Arthralgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 5 affected / 66 at risk

Adverse event: Fatigue (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 26 affected / 66 at risk

Adverse event: Headache (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 24 affected / 65 at risk

Adverse event: Myalgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 17 affected / 66 at risk

Adverse event: Shivering (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 9 affected / 65 at risk

Adverse event: Sweating (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 5 affected / 65 at risk

Adverse event: Gastrointestinal (Primary phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 5 affected / 66 at risk

Adverse event: Gastrointestinal (Booster phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 4 affected / 65 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 11 affected / 65 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pain (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the primary phase of the study
Frequency: 48 affected / 66 at risk

Adverse event: Swelling (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study
Frequency: 5 affected / 66 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 1 affected / 65 at risk

Adverse event: Arthralgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 8 affected / 65 at risk

Adverse event: Fatigue (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 20 affected / 65 at risk

Adverse event: Headache (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 21 affected / 66 at risk

Adverse event: Myalgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 16 affected / 65 at risk

Adverse event: Shivering (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 5 affected / 66 at risk

Adverse event: Sweating (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 8 affected / 66 at risk

Adverse event: Pain (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study
Frequency: 40 affected / 65 at risk

Adverse event: Swelling (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 5 affected / 65 at risk

Adverse event: Arthralgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 7 affected / 66 at risk

Adverse event: Fatigue (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 19 affected / 66 at risk

Adverse event: Headache (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 23 affected / 65 at risk

Adverse event: Myalgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 20 affected / 66 at risk

Adverse event: Shivering (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 13 affected / 65 at risk

Adverse event: Sweating (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 3 affected / 65 at risk

Adverse event: Gastrointestinal (Primary phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 3 affected / 66 at risk

Adverse event: Gastrointestinal (Booster phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 2 affected / 65 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 5 affected / 65 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Pain (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the primary phase of the study
Frequency: 61 affected / 68 at risk

Adverse event: Swelling (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study
Frequency: 6 affected / 68 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 1 affected / 68 at risk

Adverse event: Arthralgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 12 affected / 68 at risk

Adverse event: Fatigue (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 28 affected / 68 at risk

Adverse event: Headache (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 39 affected / 68 at risk

Adverse event: Myalgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 17 affected / 68 at risk

Adverse event: Shivering (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 8 affected / 68 at risk

Adverse event: Sweating (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 11 affected / 68 at risk

Adverse event: Pain (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study
Frequency: 54 affected / 68 at risk

Adverse event: Swelling (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 3 affected / 68 at risk

Adverse event: Arthralgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 6 affected / 68 at risk

Adverse event: Fatigue (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 24 affected / 68 at risk

Adverse event: Headache (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 32 affected / 68 at risk

Adverse event: Myalgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 28 affected / 68 at risk

Adverse event: Shivering (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 15 affected / 68 at risk

Adverse event: Sweating (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 4 affected / 68 at risk

Adverse event: Gastrointestinal (Primary phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 9 affected / 68 at risk

Adverse event: Gastrointestinal (Booster phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 8 affected / 68 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 7 affected / 68 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Pain (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the primary phase of the study
Frequency: 51 affected / 110 at risk

Adverse event: Swelling (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study
Frequency: 1 affected / 110 at risk

Adverse event: Arthralgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 8 affected / 110 at risk

Adverse event: Fatigue (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 36 affected / 110 at risk

Adverse event: Headache (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 45 affected / 110 at risk

Adverse event: Myalgia (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 20 affected / 110 at risk

Adverse event: Shivering (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 16 affected / 110 at risk

Adverse event: Sweating (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 15 affected / 110 at risk

Adverse event: Pain (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study
Frequency: 49 affected / 110 at risk

Adverse event: Arthralgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 13 affected / 110 at risk

Adverse event: Fatigue (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE was reported during the Primary phase of the study.
Frequency: 36 affected / 110 at risk

Adverse event: Headache (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 25 affected / 110 at risk

Adverse event: Myalgia (Primary phase)
Serious: no
Organ System: General disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 21 affected / 110 at risk

Adverse event: Shivering (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE reported during the Booster phase of the study.
Frequency: 9 affected / 110 at risk

Adverse event: Sweating (Booster phase)
Serious: no
Organ System: General disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 9 affected / 110 at risk

Adverse event: Gastrointestinal (Primary phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE reported during the Primary phase of the study.
Frequency: 8 affected / 110 at risk

Adverse event: Gastrointestinal (Booster phase)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively. AE was reported during the Booster phase of the study.
Frequency: 5 affected / 110 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: 1 subject moved out of the study area thereby withdrawing from the study in Flu1-F1-2D Group and Flu1-F2-2D Group, respectively.
Frequency: 2 affected / 110 at risk