Safety of One Dose of Meningococcal ACWY Conjugate Vaccin... | NCT01766206

ID	Type	Description	Link
V59_62	Other Identifier	Novartis

Status Module

Label	Type	Description	Intervention Names
MenACWY-CRM Group	Experimental	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.	Biological: MenACWY-CRM (Menveo)

Name	Type	Description	Arm Group Labels	Other Names
MenACWY-CRM (Menveo)	Biological	One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)	Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.	From Day 1 of vaccination to Day 7 post vaccination
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.	From Day 1 of vaccination to Day 7 post vaccination
Number of Subjects Reporting Medically Attended AEs (MAAEs)	MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.	From Day 1 of vaccination to study termination (Day 29/early termination)
Number of Subjects Reporting Serious AEs (SAEs)	An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ansan		15381	South Korea
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
20849427	Background	Al-Tawfiq JA, Clark TA, Memish ZA. Meningococcal disease: the organism, clinical presentation, and worldwide epidemiology. J Travel Med. 2010 Sep-Oct;17 Suppl:3-8. doi: 10.1111/j.1708-8305.2010.00448.x. No abstract available.
19050348	Background	Bae SM, Kang YH. Serological and genetic characterization of meningococcal isolates in Korea. Jpn J Infect Dis. 2008 Nov;61(6):434-7.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MenACWY-CRM Group	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 13, 2012	Jul 20, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)

Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

This analysis was performed on the Safety per protocol set, which included enrolled subjects aged from 2 months to 55 years, who signed an informed consent, underwent screening, received a subject number and received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.

Posted

Count of Participants

Participants

From Day 1 of vaccination to Day 7 post vaccination

ID	Title	Description
OG000	MenACWY-CRM Group	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Units	Counts
Participants	OG0003920

Title

Denominators

Categories

Any injection site tenderness, 2 - 23 months

- ParticipantsOG000653

Title	Measurements
	OG00067

Any injection site erythema, 2 - 23 months

- ParticipantsOG000

Primary

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent,underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.

Posted

Count of Participants

Participants

From Day 1 of vaccination to Day 7 post vaccination

ID	Title	Description
OG000	MenACWY-CRM Group	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Units	Counts
Participants	OG000

Primary

Number of Subjects Reporting Medically Attended AEs (MAAEs)

MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.

Posted

Count of Participants

Participants

From Day 1 of vaccination to study termination (Day 29/early termination)

ID	Title	Description
OG000	MenACWY-CRM Group	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Units	Counts
Participants	OG000

Primary

Number of Subjects Reporting Serious AEs (SAEs)

An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.

Posted

Count of Participants

Participants

From Day 1 of vaccination to study termination (Day 29/early termination)

ID	Title	Description
OG000	MenACWY-CRM Group	Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site tenderness	General disorders	21.0	Systematic Assessment	This symptom was assessed as a solicited local AE.	EG000202 events202 affected3,939 at risk
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited local AE.	EG000592 events592 affected3,939 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited local AE.	EG000195 events195 affected3,939 at risk
Injection site induration	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited local AE.	EG000158 events158 affected3,939 at risk
Eating disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG000132 events132 affected3,939 at risk
Sleepiness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG000143 events143 affected3,939 at risk
Irritability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG000254 events254 affected3,939 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a general AE.	EG00070 events70 affected3,939 at risk
Diarrhea	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00089 events89 affected3,939 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00031 events31 affected3,939 at risk
Nausea	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00028 events28 affected3,939 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE,	EG00053 events53 affected3,939 at risk
Myalgia	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00064 events64 affected3,939 at risk
Arthralgia	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00034 events34 affected3,939 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00073 events73 affected3,939 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00074 events74 affected3,939 at risk
Fever	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a solicited general AE.	EG00087 events87 affected3,939 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG00021 events21 affected3,939 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG00031 events31 affected3,939 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG00013 events13 affected3,939 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0005 events5 affected3,939 at risk
Bronchiolitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG00011 events11 affected3,939 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0003 events3 affected3,939 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0004 events4 affected3,939 at risk
Tonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0003 events3 affected3,939 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0004 events4 affected3,939 at risk
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Herpangina	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Viral pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Periodontitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment		EG0008 events8 affected3,939 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment		EG0009 events9 affected3,939 at risk
Injection site induration	General disorders	MedDRA 21.0	Systematic Assessment		EG0007 events7 affected3,939 at risk
Injection site pruritus	General disorders	MedDRA 21.0	Systematic Assessment		EG0007 events7 affected3,939 at risk
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Injection site warmth	General disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Injection site bruising	General disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0005 events5 affected3,939 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0005 events5 affected3,939 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0004 events4 affected3,939 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0007 events7 affected3,939 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0005 events5 affected3,939 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0005 events5 affected3,939 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0004 events4 affected3,939 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Eating disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment		EG0006 events6 affected3,939 at risk
Irritability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment		EG0004 events4 affected3,939 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment		EG0002 events1 affected3,939 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment		EG0002 events2 affected3,939 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Burning sensation	Nervous system disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Eye discharge	Eye disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Ocular hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Lymphadentitis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Prostatic cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG000100 events94 affected3,939 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00093 events82 affected3,939 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00042 events40 affected3,939 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00031 events30 affected3,939 at risk
Bronchiolitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00029 events28 affected3,939 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00022 events22 affected3,939 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00016 events15 affected3,939 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00013 events13 affected3,939 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00012 events12 affected3,939 at risk
Tonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00017 events17 affected3,939 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00011 events11 affected3,939 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0008 events8 affected3,939 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0006 events6 affected3,939 at risk
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0005 events5 affected3,939 at risk
Impetigo	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0005 events5 affected3,939 at risk
Herpes dermatitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0004 events4 affected3,939 at risk
Otitis media acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0004 events4 affected3,939 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Herpangina	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Viral pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Tracheitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Bacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Croup infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Exanthema subitum	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Periodontitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00017 events15 affected3,939 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Injection site pruritus	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Injection site rash	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00023 events22 affected3,939 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0007 events7 affected3,939 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0008 events8 affected3,939 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0007 events7 affected3,939 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0007 events7 affected3,939 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0006 events6 affected3,939 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00020 events20 affected3,939 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00011 events11 affected3,939 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00012 events10 affected3,939 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0008 events8 affected3,939 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG00018 events18 affected3,939 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0008 events8 affected3,939 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Eating disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0003 events3 affected3,939 at risk
Irritability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events1 affected3,939 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0002 events2 affected3,939 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Prostatic cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	This symptom was assessed as a MAAE.	EG0001 events1 affected3,939 at risk
Atopy	Immune system disorders	MedDRA 21.0	Non-systematic Assessment		EG0001 events1 affected3,939 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk
sleepiness	Nervous system disorders	MedDRA 21.0	Systematic Assessment		EG0001 events1 affected3,939 at risk

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures