Study: NCT00703053

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 1 affected / 26 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 4 affected / 26 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 8 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 9 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 6 affected / 26 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 11 affected / 26 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 18 affected / 26 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 5 affected / 26 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 8 affected / 26 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 1 affected / 26 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 4 affected / 26 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 3 affected / 25 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 5 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 9 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 13 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 2 affected / 25 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 13 affected / 25 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 18 affected / 25 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 7 affected / 25 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 8 affected / 25 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 4 affected / 25 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 5 affected / 25 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 5 affected / 51 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 16 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 17 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 21 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 5 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 17 affected / 51 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 29 affected / 51 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 11 affected / 51 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 20 affected / 51 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 6 affected / 51 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 8 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 3 affected / 48 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 14 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 14 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 23 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 7 affected / 48 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 18 affected / 48 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 37 affected / 48 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 7 affected / 48 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 11 affected / 48 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 3 affected / 48 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 4 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 8 affected / 51 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 19 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 18 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 24 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 7 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 23 affected / 51 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 34 affected / 51 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 11 affected / 51 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 19 affected / 51 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 7 affected / 51 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 9 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 4 affected / 49 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 12 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 11 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 20 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 4 affected / 49 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 31 affected / 49 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 36 affected / 49 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 10 affected / 49 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 14 affected / 49 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 8 affected / 49 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 9 affected / 49 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 6 affected / 52 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 15 affected / 52 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 16 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 19 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 7 affected / 52 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 20 affected / 52 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 29 affected / 52 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 11 affected / 52 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 12 affected / 52 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 3 affected / 52 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 4 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 97 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 5 affected / 97 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 25 affected / 97 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 23 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 32 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 9 affected / 97 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 38 affected / 97 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 66 affected / 97 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 7 affected / 97 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 13 affected / 97 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 5 affected / 97 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 6 affected / 97 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 103 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 103 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Oral temperature was measured daily for days 0-7 after vaccination. Temperatures 37.8 degrees Celsius or greater were considered fever.
Frequency: 12 affected / 103 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Fatigue/Malaise (feeling unwell)" on the Memory Aid.
Frequency: 39 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited for Days 0-7 after each vaccination as "Myalgia(Muscle aches/pains)" on the Memory Aid.
Frequency: 36 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited for Days 0-7 after each vaccination as "Headache" on the Memory Aid.
Frequency: 48 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited for Days 0-7 after each vaccination as "Nausea" on the Memory Aid.
Frequency: 20 affected / 103 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Pain" under Injection Site Reactions on the Memory Aid.
Frequency: 65 affected / 103 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Tenderness" under Injection Site Reactions on the Memory Aid.
Frequency: 90 affected / 103 at risk

Adverse event: Injection site erythema (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid.
Frequency: 18 affected / 103 at risk

Adverse event: Injection site erythema (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Erythema/Redness" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed erythema. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 28 affected / 103 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid on a scale of impact on daily activities.
Frequency: 15 affected / 103 at risk

Adverse event: Injection site swelling (measured values)
Serious: no
Organ System: General disorders
Notes: Solicited for Days 0-7 after each vaccination as "Induration/Swelling" under Injection Site Reactions on the Memory Aid. Subjects measured the diameter of observed swelling. Measurements greater than 0 are counted as the reaction occurring.
Frequency: 20 affected / 103 at risk