Study: NCT00962780

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 301 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 301 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 301 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 301 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 301 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 301 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 301 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 301 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 301 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 301 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Salivary gland enlargement
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 301 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 301 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 301 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 301 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 301 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 301 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 301 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 301 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 301 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 301 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 301 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 301 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 301 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 301 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 180 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 179 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 173 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 191 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 184 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 181 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pain at injection site (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 156 affected / 238 at risk

Adverse event: Pain at injection site (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 127 affected / 228 at risk

Adverse event: Pain at injection site (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 188 at risk

Adverse event: Pain at injection site (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 175 at risk

Adverse event: Fever (≥38°C)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 189 at risk

Adverse event: Fever (≥38°C but <38.5°C)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 179 at risk

Adverse event: Fever (≥38.5°C but <39°C)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 174 at risk

Adverse event: Fever (≥39°C but ≤40°C)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 174 at risk

Adverse event: Fever (>40°C)
Serious: no
Organ System: General disorders
Notes: All reporting of fever \>40 degrees C except 2 participants in 13vPnC Dose 1 and 1 participant in 13vPnC Dose 3 were confirmed as data entry errors.
Frequency: 14 affected / 181 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Frequency: 123 affected / 230 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Frequency: 93 affected / 218 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 195 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 178 at risk

Adverse event: Headache (Any)
Serious: no
Organ System: General disorders
Frequency: 111 affected / 220 at risk

Adverse event: Headache (Mild)
Serious: no
Organ System: General disorders
Frequency: 96 affected / 209 at risk

Adverse event: Headache (Moderate)
Serious: no
Organ System: General disorders
Frequency: 39 affected / 191 at risk

Adverse event: Headache (Severe)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 176 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 180 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 180 at risk

Adverse event: Vomiting (Moderate)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 172 at risk

Adverse event: Vomiting (Severe)
Serious: no
Organ System: General disorders
Notes: All reporting of severe vomiting were confirmed as data entry errors.
Frequency: 2 affected / 173 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Frequency: 60 affected / 199 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Frequency: 49 affected / 196 at risk

Adverse event: Diarrhea (Moderate)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 177 at risk

Adverse event: Diarrhea (Severe)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 173 at risk

Adverse event: Muscle pain (Any)
Serious: no
Organ System: General disorders
Frequency: 126 affected / 226 at risk

Adverse event: Muscle pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 100 affected / 213 at risk

Adverse event: Muscle pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 36 affected / 187 at risk

Adverse event: Muscle pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 177 at risk

Adverse event: Joint pain (Any)
Serious: no
Organ System: General disorders
Frequency: 79 affected / 205 at risk

Adverse event: Joint pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 63 affected / 199 at risk

Adverse event: Joint pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 28 affected / 184 at risk

Adverse event: Joint pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 175 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 290 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Pharyngitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 290 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 290 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 290 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 290 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Pharyngitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 290 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 290 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 290 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 290 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 290 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 290 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 290 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 290 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 290 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 290 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 290 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 187 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 186 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 180 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 191 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 190 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 184 at risk

Adverse event: Pain at injection site (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 166 affected / 236 at risk

Adverse event: Pain at injection site (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 139 affected / 227 at risk

Adverse event: Pain at injection site (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 199 at risk

Adverse event: Pain at injection site (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 179 at risk

Adverse event: Fever (≥38°C)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 190 at risk

Adverse event: Fever (≥38°C but <38.5°C)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 183 at risk

Adverse event: Fever (≥38.5°C but <39°C)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 183 at risk

Adverse event: Fever (≥39°C but ≤40°C)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 184 at risk

Adverse event: Fever (>40°C)
Serious: no
Organ System: General disorders
Notes: All reporting of fever \>40 degrees C except 2 participants in 13vPnC Dose 1 and 1 participant in 13vPnC Dose 3 were confirmed as data entry errors.
Frequency: 2 affected / 180 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Frequency: 86 affected / 211 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Frequency: 69 affected / 207 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 184 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 183 at risk

Adverse event: Headache (Any)
Serious: no
Organ System: General disorders
Frequency: 81 affected / 207 at risk

Adverse event: Headache (Mild)
Serious: no
Organ System: General disorders
Frequency: 59 affected / 199 at risk

Adverse event: Headache (Moderate)
Serious: no
Organ System: General disorders
Frequency: 39 affected / 190 at risk

Adverse event: Headache (Severe)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 182 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 185 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 183 at risk

Adverse event: Vomiting (Moderate)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 179 at risk

Adverse event: Vomiting (Severe)
Serious: no
Organ System: General disorders
Notes: All reporting of severe vomiting were confirmed as data entry errors.
Frequency: 3 affected / 179 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 190 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 187 at risk

Adverse event: Diarrhea (Moderate)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 180 at risk

Adverse event: Diarrhea (Severe)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 179 at risk

Adverse event: Muscle pain (Any)
Serious: no
Organ System: General disorders
Frequency: 97 affected / 216 at risk

Adverse event: Muscle pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 75 affected / 208 at risk

Adverse event: Muscle pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 191 at risk

Adverse event: Muscle pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 180 at risk

Adverse event: Joint pain (Any)
Serious: no
Organ System: General disorders
Frequency: 61 affected / 201 at risk

Adverse event: Joint pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 43 affected / 193 at risk

Adverse event: Joint pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 188 at risk

Adverse event: Joint pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 179 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 186 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 186 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 186 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 186 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Pharyngitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 186 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 186 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 186 at risk

Adverse event: Nasal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 186 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 154 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 153 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 152 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 160 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 157 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 154 at risk

Adverse event: Pain at injection site (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 131 affected / 213 at risk

Adverse event: Pain at injection site (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 107 affected / 201 at risk

Adverse event: Pain at injection site (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 167 at risk

Adverse event: Pain at injection site (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Fever (≥38°C)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 158 at risk

Adverse event: Fever (≥38°C but <38.5°C)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 155 at risk

Adverse event: Fever (≥38.5°C but <39°C)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 153 at risk

Adverse event: Fever (≥39°C but ≤40°C)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 152 at risk

Adverse event: Fever (>40°C)
Serious: no
Organ System: General disorders
Notes: All reporting of fever \>40 degrees C except 2 participants in 13vPnC Dose 1 and 1 participant in 13vPnC Dose 3 were confirmed as data entry errors.
Frequency: 4 affected / 153 at risk

Adverse event: Fatigue (Any)
Serious: no
Organ System: General disorders
Frequency: 66 affected / 183 at risk

Adverse event: Fatigue (Mild)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 177 at risk

Adverse event: Fatigue (Moderate)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 163 at risk

Adverse event: Fatigue (Severe)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 156 at risk

Adverse event: Headache (Any)
Serious: no
Organ System: General disorders
Frequency: 57 affected / 177 at risk

Adverse event: Headache (Mild)
Serious: no
Organ System: General disorders
Frequency: 45 affected / 171 at risk

Adverse event: Headache (Moderate)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 160 at risk

Adverse event: Headache (Severe)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 154 at risk

Adverse event: Vomiting (Any)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 159 at risk

Adverse event: Vomiting (Mild)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 156 at risk

Adverse event: Vomiting (Moderate)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 155 at risk

Adverse event: Vomiting (Severe)
Serious: no
Organ System: General disorders
Notes: All reporting of severe vomiting were confirmed as data entry errors.
Frequency: 3 affected / 153 at risk

Adverse event: Diarrhea (Any)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 162 at risk

Adverse event: Diarrhea (Mild)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 160 at risk

Adverse event: Diarrhea (Moderate)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 153 at risk

Adverse event: Diarrhea (Severe)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 154 at risk

Adverse event: Muscle pain (Any)
Serious: no
Organ System: General disorders
Frequency: 81 affected / 191 at risk

Adverse event: Muscle pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 57 affected / 182 at risk

Adverse event: Muscle pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 163 at risk

Adverse event: Muscle pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 156 at risk

Adverse event: Joint pain (Any)
Serious: no
Organ System: General disorders
Frequency: 49 affected / 174 at risk

Adverse event: Joint pain (Mild)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 170 at risk

Adverse event: Joint pain (Moderate)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 159 at risk

Adverse event: Joint pain (Severe)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 152 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 282 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 282 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 282 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 282 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 282 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 282 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 282 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 282 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 282 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 282 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Spondylolisthesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 282 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 282 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 282 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Pharyngitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 182 at risk

Adverse event: Scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 182 at risk