Study: NCT03529773

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 6 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 3 affected / 11 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 11 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 11 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 11 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 2 affected / 11 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 11 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 9 affected / 12 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Blood pressure systolic decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 10 affected / 12 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 8 affected / 12 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 3 affected / 12 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 12 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 1 affected / 12 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Alcohol poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 17 affected / 41 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 41 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 28 affected / 41 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 23 affected / 41 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 17 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 41 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 5 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 14 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Respiratory symptom
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 3 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 21 affected / 41 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 25 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 25 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 27 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 21 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 12 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 26 affected / 41 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 30 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 9 affected / 41 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 9 affected / 41 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 23 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 24 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 3 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 21 affected / 41 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 9 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 17 affected / 41 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Maisonneuve fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Oesophageal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 41 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory symptom
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 10 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 4 affected / 40 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 40 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Viral sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Invasive breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Tonsil cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 42 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 10 affected / 42 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 5 affected / 42 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Vestibular neuronitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 42 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 42 at risk

Adverse event: Neck mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 42 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 1 affected / 42 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 42 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 5 affected / 40 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infected cyst
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Intervertebral disc degeneration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 41 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 13 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 3 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 16 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 41 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 12 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 12 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Autonomic failure syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 43 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 16 affected / 43 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 5 affected / 43 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 3 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 7 affected / 43 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Jaw fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 43 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 43 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 3 affected / 43 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 43 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 43 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 42 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 16 affected / 42 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 42 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 42 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 42 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 13 affected / 42 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 42 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 6 affected / 42 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 23 affected / 42 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 21 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 15 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 16 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 40 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 21 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 17 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 15 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 41 at risk

Adverse event: Pregnancy of partner
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 27 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 12 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 21 affected / 40 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 9 affected / 40 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 40 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 24 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Galactorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 25 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 7 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 19 affected / 41 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 6 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 30 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 14 affected / 41 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 9 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 26 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 10 affected / 41 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 41 at risk

Adverse event: Sinusitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 11 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 10 affected / 40 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 11 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 9 affected / 40 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 40 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 9 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Sensation of foreign body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 4 affected / 40 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 9 affected / 40 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nasal septum deviation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 9 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 12 affected / 41 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 41 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 14 affected / 41 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 4 affected / 41 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 17 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 4 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 2 affected / 40 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 10 affected / 40 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 20 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 11 affected / 40 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 42 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 17 affected / 42 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 5 affected / 42 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
Frequency: 2 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 8 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 14 affected / 42 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 18 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 21 affected / 42 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 5 affected / 42 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 15 affected / 42 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lung carcinoma cell type unspecified stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain (PAIN AT INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 2 affected / 40 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo \& placebo \& SIIV Age 65-85 years were at risk.
Frequency: 6 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Arthralgia (JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 7 affected / 40 at risk

Adverse event: Myalgia (MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 5 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diabetic foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 8 affected / 40 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide \&placebo\&SIIV age18-49 Years\&40 participants(expanded cohort) placebo \& placebo \& SIIV Age 65-85 Years arms were at risk.
Frequency: 3 affected / 40 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
Frequency: 1 affected / 40 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: 11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
Frequency: 10 affected / 40 at risk