Study Evaluating Safety of 13-Valent Pneumococcal Conjuga... | NCT00500266

Label	Type	Description	Intervention Names
1	Experimental	13-valent Pneumococcal Conjugate Vaccine	Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Name	Type	Description	Arm Group Labels	Other Names
13-valent Pneumococcal Conjugate Vaccine (13vPnC)	Biological		1

Measure	Description	Time Frame
Percentage of Participants With Pre-specified Local Reactions	Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.	Days 1 through 14
Percentage of Participants With Pre-specified Systemic Events	Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.	Days 1 through 14
Percentage of Participants Taking Pain or Antipyretic Medication	Use of pain or antipyretic medication was collected by the participants using an electronic diary.	Days 1 through 14

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Chandler	Arizona	85224	United States

ID	Title	Description
FG000	13vPnC	Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradyarrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cardiac failure	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Abscess limb	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Bacteraemia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Enteritis infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Septic shock	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Hallucination	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Mental status changes	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,049 at risk EG0011 affected1,049 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Redness (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Redness (any) = present at site of vaccination.	EG00095 affected666 at risk EG0010 affected0 at risk
Redness (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Redness (mild) = 2.5 to 5.0 cm	EG00083 affected660 at risk EG0010 affected0 at risk
Redness (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Redness (moderate) = 5.1 to 10.0 cm	EG00042 affected649 at risk EG0010 affected0 at risk
Redness (severe)	Skin and subcutaneous tissue disorders	Local reactions	Non-systematic Assessment	Redness (severe) = >10.0 cm	EG0007 affected638 at risk EG0010 affected0 at risk
Swelling (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Swelling (any) = present at site of vaccination	EG00085 affected664 at risk EG0010 affected0 at risk
Swelling (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Swelling (mild) = 2.5 to 5.0 cm	EG00072 affected658 at risk EG0010 affected0 at risk
Swelling (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Swelling (moderate) = 5.1 to 10.0 cm	EG00036 affected651 at risk EG0010 affected0 at risk
Swelling (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Swelling (severe) = 10.0 cm	EG0004 affected636 at risk EG0010 affected0 at risk
Pain (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Pain (any) = present at site of vaccination.	EG000396 affected777 at risk EG0010 affected0 at risk
Pain (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Pain (mild) = no interference with activity.	EG000380 affected770 at risk EG0010 affected0 at risk
Pain (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Pain (moderate) = some interference with activity.	EG00059 affected656 at risk EG0010 affected0 at risk
Pain (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Pain (severe) = prevents routine daily activity.	EG0001 affected634 at risk EG0010 affected0 at risk
Limitation of arm movement (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Limitation of arm movement (any) = present due to vaccination.	EG000110 affected679 at risk EG0010 affected0 at risk
Limitation of arm movement (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Limitation of arm movement (mild) = some limitation of arm movement.	EG000100 affected674 at risk EG0010 affected0 at risk
Limitation of arm movement (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Limitation of arm movement (moderate) = unable to move arm above head but able to move arm above shoulder.	EG00010 affected636 at risk EG0010 affected0 at risk
Limitation of arm movement (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Limitation of arm movement (severe) = unable to move arm above shoulder.	EG00010 affected640 at risk EG0010 affected0 at risk
Fever (any)	General disorders	Systemic events	Systematic Assessment	Fever (any) = ≥38 degrees C	EG00013 affected641 at risk EG0010 affected0 at risk
Fever (mild)	General disorders	Systemic events	Systematic Assessment	Fever (mild) = ≥38 degrees C but <38.5 degrees C	EG0005 affected636 at risk EG0010 affected0 at risk
Fever (moderate)	General disorders	Systemic events	Systematic Assessment	Fever (moderate) = ≥38.5 degrees C but <39 degrees C.	EG0000 affected634 at risk EG0010 affected0 at risk
Fever (severe)	General disorders	Systemic events	Systematic Assessment	Fever (severe) = ≥39 degrees C but ≤40 degrees C	EG0002 affected635 at risk EG0010 affected0 at risk
Fever (potentially life threatening)	General disorders	Systemic events	Systematic Assessment	Fever (potentially life threatening) = >40 degrees C	EG0006 affected638 at risk EG0010 affected0 at risk
Fatigue (any)	General disorders	Systemic events	Systematic Assessment	Fatigue (any) = fatigue present	EG000252 affected733 at risk EG0010 affected0 at risk
Fatigue (mild)	General disorders	Systemic events	Systematic Assessment	Fatigue (mild) = no interference with activity.	EG000204 affected710 at risk EG0010 affected0 at risk
Fatigue (moderate)	General disorders	Systemic events	Systematic Assessment	Fatigue (moderate) = some interference with activity.	EG000104 affected683 at risk EG0010 affected0 at risk
Fatigue (severe)	General disorders	Systemic events	Systematic Assessment	Fatigue (severe) = prevents routine daily activity.	EG00013 affected639 at risk EG0010 affected0 at risk
Headache (any)	General disorders	Systemic events	Systematic Assessment	Headache (any) = headache present.	EG000183 affected702 at risk EG0010 affected0 at risk
Headache (mild)	General disorders	Systemic events	Systematic Assessment	Headache (mild) = no interference with activity.	EG000168 affected696 at risk EG0010 affected0 at risk
Headache (moderate)	General disorders	Systemic events	Systematic Assessment	Headache (moderate) = some interference with activity.	EG00059 affected655 at risk EG0010 affected0 at risk
Headache (severe)	General disorders	Systemic events	Systematic Assessment	Headache (severe) = prevents routine daily activity.	EG0005 affected637 at risk EG0010 affected0 at risk
Chills	General disorders	Systemic events	Systematic Assessment		EG00049 affected651 at risk EG0010 affected0 at risk
Rash	General disorders	Systemic events	Systematic Assessment		EG00055 affected658 at risk EG0010 affected0 at risk
Vomiting (any)	General disorders	Systemic events	Systematic Assessment	Vomiting (any) = vomiting present.	EG0006 affected638 at risk EG0010 affected0 at risk
Vomiting (mild)	General disorders	Systemic events	Systematic Assessment	Vomiting (mild) = no interference with activity or 1 to 2 times in 24 hours.	EG0005 affected637 at risk EG0010 affected0 at risk
Vomiting (moderate)	General disorders	Systemic events	Systematic Assessment	Vomiting (moderate) = some interference with activity or more than 2 times in 24 hours.	EG0001 affected635 at risk EG0010 affected0 at risk
Vomiting (severe)	General disorders	Systemic events	Systematic Assessment	Vomiting (severe) = prevents routine daily activity.	EG0000 affected634 at risk EG0010 affected0 at risk
Decreased appetite	General disorders	Systemic events	Systematic Assessment		EG00075 affected668 at risk EG0010 affected0 at risk
Diarrhea (any)	General disorders	Systemic events	Systematic Assessment	Diarrhea (any) = diarrhea present.	EG00099 affected684 at risk EG0010 affected0 at risk
Diarrhea (mild)	General disorders	Systemic events	Systematic Assessment	Diarrhea (mild) = 2 to 3 loose stools in 24 hours.	EG00087 affected678 at risk EG0010 affected0 at risk
Diarrhea (moderate)	General disorders	Systemic events	Systematic Assessment	Diarrhea (moderate) = 4 to 5 loose stools in 24 hours.	EG00022 affected644 at risk EG0010 affected0 at risk
Diarrhea (severe)	General disorders	Systemic events	Systematic Assessment	Diarrhea (severe) = 6 or more loose stools in 24 hours.	EG0002 affected635 at risk EG0010 affected0 at risk
New generalized muscle pain (any)	General disorders	Systemic events	Systematic Assessment	New generalized muscle pain (any) = new generalized muscle pain present.	EG000177 affected700 at risk EG0010 affected0 at risk
New generalized muscle pain (mild)	General disorders	Systemic events	Systematic Assessment	New generalized muscle pain (mild) = no interference with activity.	EG000139 affected679 at risk EG0010 affected0 at risk
New generalized muscle pain (moderate)	General disorders	Systemic events	Systematic Assessment	New generalized muscle pain (moderate) = some interference with activity.	EG00052 affected658 at risk EG0010 affected0 at risk
New generalized muscle pain (severe)	General disorders	Systemic events	Systematic Assessment	New generalized muscle pain (severe) = prevents routine daily activity.	EG0004 affected636 at risk EG0010 affected0 at risk
Aggravated generalized muscle pain (any)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized muscle pain (any) = aggravated generalized muscle pain present.	EG00082 affected669 at risk EG0010 affected0 at risk
Aggravated generalized muscle pain (mild)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized muscle pain (mild) = no interference with activity.	EG00049 affected650 at risk EG0010 affected0 at risk
Aggravated generalized muscle pain (moderate)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized muscle pain (moderate) = some interference with activity.	EG00042 affected655 at risk EG0010 affected0 at risk
Aggravated generalized muscle pain (severe)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized muscle pain (severe) = prevents routine daily activity.	EG0009 affected639 at risk EG0010 affected0 at risk
New generalized joint pain (any)	General disorders	Systemic events	Systematic Assessment	New generalized joint pain (any) = new generalized joint pain present.	EG00085 affected665 at risk EG0010 affected0 at risk
New generalized joint pain (mild)	General disorders	Systemic events	Systematic Assessment	New generalized joint pain (mild) = no interference with activity.	EG00053 affected651 at risk EG0010 affected0 at risk
New generalized joint pain (moderate)	General disorders	Systemic events	Systematic Assessment	New generalized joint pain (moderate) = some interference with activity.	EG00037 affected648 at risk EG0010 affected0 at risk
New generalized joint pain (severe)	General disorders	Systemic events	Systematic Assessment	New generalized joint pain (severe) = prevents routine daily activity.	EG0005 affected637 at risk EG0010 affected0 at risk
Aggravated generalized joint pain (any)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized joint pain (any) = aggravated generalized joint pain present.	EG00064 affected661 at risk EG0010 affected0 at risk
Aggravated generalized joint pain (mild)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized joint pain (mild) = no interference with activity.	EG00037 affected647 at risk EG0010 affected0 at risk
Aggravated generalized joint pain (moderate)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized joint pain (moderate) = some interference with activity.	EG00033 affected647 at risk EG0010 affected0 at risk
Aggravated generalized joint pain (severe)	General disorders	Systemic events	Systematic Assessment	Aggravated generalized joint pain (severe) = prevents routine daily activity.	EG0007 affected637 at risk EG0010 affected0 at risk
Bradycardia	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Blepharitis	Eye disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0006 affected1,049 at risk EG0010 affected1,049 at risk
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0006 affected1,049 at risk EG0010 affected1,049 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0011 affected1,049 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Retching	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment		EG0004 affected1,049 at risk EG0011 affected1,049 at risk
Injection site pain	General disorders	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Injection site haematoma	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Injection site pruritus	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Injection site swelling	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Pain	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Seasonal allergy	Immune system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0006 affected1,049 at risk EG0011 affected1,049 at risk
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0004 affected1,049 at risk EG0011 affected1,049 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0004 affected1,049 at risk EG0010 affected1,049 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0004 affected1,049 at risk EG0011 affected1,049 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Acute sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Ear infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Eye infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Localised infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Nail infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Tinea cruris	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0011 affected1,049 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Blood glucose increased	Investigations	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0006 affected1,049 at risk EG0014 affected1,049 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0006 affected1,049 at risk EG0010 affected1,049 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0012 affected1,049 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0011 affected1,049 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0012 affected1,049 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0015 affected1,049 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0013 affected1,049 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Endobronchial lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Paraesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Tremor	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0012 affected1,049 at risk
Stress	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Bladder spasm	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0012 affected1,049 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0010 affected1,049 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0002 affected1,049 at risk EG0010 affected1,049 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0013 affected1,049 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0011 affected1,049 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment		EG0003 affected1,049 at risk EG0013 affected1,049 at risk
Hypotension	Vascular disorders	MedDRA	Non-systematic Assessment		EG0001 affected1,049 at risk EG0010 affected1,049 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Angina unstable	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cataract	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Pain	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Suprapubic pain	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Oral herpes	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Cardiac murmur	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Narcolepsy	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Restless legs syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Haematuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Renal mass	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0013 affected1,049 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0012 affected1,049 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Milia	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Joint prosthesis user	Social circumstances	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk
Temporal arteritis	Vascular disorders	MedDRA	Non-systematic Assessment		EG0000 affected1,049 at risk EG0011 affected1,049 at risk

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	13vPnC: Visit 1 to Visit 2	Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.			10	1,049	486	1,049
EG001	13vPnC: 6-month Follow-up	Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.			41	1,049	77	1,049