A Study on the Safety, Tolerability and Immune Response o... | NCT05082285

NCT05082285

ID	Type	Description	Link
2021-001367-24	EudraCT Number
2023-506449-40-00	EU Trial (CTIS) Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MenACWY-7B low dose Group	Experimental	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.	Combination Product: MenACWY-7B low dose vaccine
MenB+MenACWY-TT Group	Active Comparator	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.	Combination Product: MenB vaccine Combination Product: MenACWY-TT vaccine
MenACWY-7B high dose Group	Experimental	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.	Combination Product: MenACWY-7B high dose vaccine
ABCWY-1Gen Group	Experimental	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.	Combination Product: MenABCWY-1Gen vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MenACWY-7B low dose vaccine	Combination Product	MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.	MenACWY-7B low dose Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1	The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group.	From Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1	The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature >38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.	From Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61		From Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61		From Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301		From Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301		From Day 301 to Day 307
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

Exclusion Criteria:

Medical conditions

Current or previous, confirmed or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
Progressive, unstable or uncontrolled clinical conditions.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
Congenital or peripartum disorders resulting in a chronic condition
Major congenital defects, as assessed by the investigator.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
Abnormal function or modification of the immune system resulting from:
Autoimmune disorders or immunodeficiency syndromes.
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
Administration of long-acting immune-modifying drugs at any time during the study period.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
Previous vaccination with any meningococcal vaccine.
Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other exclusions

Child in care.
Study personnel as an immediate family or household member.
For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Santo Domingo Este			Dominican Republic
GSK Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
FG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 28, 2024	Mar 31, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
BG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
BG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
BG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

DAYS

Title

Denominators

Categories

Title	Measurements
	BG00062.2± 10.7 BG00162.3± 10.0 BG00263.6± 10.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095 BG00197 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000133 BG001132 BG002

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 Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1

The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group.

Analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention and had solicited adverse event data available for the specified duration.

Posted

Count of Participants

Participants

From Day 1 to Day 7

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB Group	Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
OG004	MenACWY-TT Group	Participants received a single dose of MenACWY-TT vaccine as a control on Day 1, Day 61 and Day 301.

Units	Counts
Participants	OG000188 OG001179 OG002175 OG003

Title

Denominators

Categories

Erythema

Title	Measurements
	OG00074 OG00174 OG00284 OG003

Primary

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1

The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature >38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.

Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 1 to Day 7

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61

Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 61 to Day 67

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB Group	Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
OG004

Primary

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61

Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 61 to Day 67

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301

Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 301 to Day 307

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB Group	Participants received a single dose of MenB vaccine as a control on Day 1, Day 61 and Day 301.
OG004

Primary

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301

Analysis was performed on the ES. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 301 to Day 307

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1

Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs (MAAEs). Any = occurrence of the event regardless of the intensity grade.

Analysis was performed on ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 1 to Day 30

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.

Primary

Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61

Analysis was performed on the ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 61 to Day 90

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301

Analysis was performed on the ES. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

From Day 301 to Day 330

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs

MAAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. AEs leading to withdrawal are defined as AEs due which the participant is considered to have withdrawn from the study as no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.

Analysis was performed on the ES.

Posted

Count of Participants

Participants

From Day 1 to Day 481

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.

Primary

Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination

The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine was evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains fHbp, NadA, NHBA, PorA, fHbp V1.13, fHbp V2 and fHbp V3.

Analysis was performed on the Full Analysis Set (FAS) which included all participants who received at least 1 dose of the study intervention and have post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 91 (1 month after the second vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.

Primary

Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 331 (1 month after the third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination

The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs.

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 91 (1 month after the second vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group

Primary

hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 331 (1 month after the third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain

The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Ratio

At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.

Primary

Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination

The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y.

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 91 (1 month after the second vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group

Primary

Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 331 (1 month after the third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination

The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs.

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 91 (1 month after the second vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group

Primary

hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Titer

At Day 331 (1 month after the third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Primary

hSBA GMRs for Each A, C, W and Y Serogroup

Analysis was performed on the FAS. Only participants with post-vaccination immunogenicity data available for the specified timepoint were included in this analysis.

Posted

Geometric Mean

90% Confidence Interval

Ratio

At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)

ID	Title	Description
OG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
OG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
OG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
OG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MenACWY-7B Low Dose Group	Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.	0	188	17	188	186	188
EG001	MenACWY-7B High Dose Group	Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.	1	179	11	179	177	179
EG002	ABCWY-1Gen Group	Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.	1	175	30	175	173	175
EG003	MenB+MenACWY-TT Group	Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.	1	182	17	182	181	182

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiopulmonary failure	Cardiac disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG0030 events0 affected182 at risk
Arnold-Chiari malformation	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Pyrexia	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Hypersensitivity	Immune system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Milk allergy	Immune system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Abscess limb	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Amoebic dysentery	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Bacterial sepsis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Bronchiolitis	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0011 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Bronchitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Bronchitis viral	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
COVID-19	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Dysentery	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Ear infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Gastroenteritis	Infections and infestations	v28.1	Systematic Assessment	EG0003 events3 affected188 at risk EG0010 events0 affected179 at risk EG0024 events4 affected175 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Gastrointestinal infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Influenza	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Klebsiella sepsis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Lower respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Mastoiditis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Otitis media	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Pneumonia	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0012 events2 affected179 at risk EG0025 events4 affected175 at risk EG003
Pneumonia bacterial	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Respiratory tract infection viral	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Rhinovirus infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Staphylococcal sepsis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Streptococcal sepsis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Upper respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Urinary tract infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Viral infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Skin injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Respiratory syncytial virus test positive	Investigations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Facial asymmetry	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Febrile convulsion	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0014 events4 affected179 at risk EG0024 events4 affected175 at risk EG003
Fontanelle bulging	Nervous system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Nephrocalcinosis	Renal and urinary disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Urinary tract inflammation	Renal and urinary disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG0031 events1 affected182 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Leukopenia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Neutropenia	Blood and lymphatic system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Brachycephaly	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Congenital naevus	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Congenital nail disorder	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Naevus flammeus	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Phimosis	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Plagiocephaly	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Talipes	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Tethered oral tissue	Congenital, familial and genetic disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Ear pain	Ear and labyrinth disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Precocious puberty	Endocrine disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Anisometropia	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Blepharitis	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Chalazion	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Conjunctivitis allergic	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Corneal erosion	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Dacryostenosis acquired	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Eczema eyelids	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Erythema of eyelid	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Eye allergy	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Eye movement disorder	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Eyelid oedema	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Hypermetropia	Eye disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Lacrimation increased	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Myopia	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Strabismus	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Visual impairment	Eye disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Abdominal distension	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Abdominal pain	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Angular cheilitis	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Constipation	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0005 events5 affected188 at risk EG0012 events2 affected179 at risk EG0028 events7 affected175 at risk EG003
Diarrhoea	Gastrointestinal disorders	v28.1	Systematic Assessment	EG00061 events49 affected188 at risk EG00176 events59 affected179 at risk EG00269 events52 affected175 at risk EG003
Dyschezia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Enteritis	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0024 events2 affected175 at risk EG003
Flatulence	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Food poisoning	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Food protein-induced enterocolitis syndrome	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0003 events3 affected188 at risk EG0013 events3 affected179 at risk EG0021 events1 affected175 at risk EG003
Haematochezia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0002 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Infant dyschezia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Infantile colic	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0005 events5 affected188 at risk EG0013 events3 affected179 at risk EG0026 events5 affected175 at risk EG003
Inguinal hernia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Mouth ulceration	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Mucous stools	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Nausea	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Oral pain	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Sandifer's syndrome	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Stomatitis	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Teething	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0005 events5 affected188 at risk EG0012 events2 affected179 at risk EG0024 events4 affected175 at risk EG003
Umbilical hernia	Gastrointestinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Vomiting	Gastrointestinal disorders	v28.1	Systematic Assessment	EG00060 events51 affected188 at risk EG00162 events46 affected179 at risk EG00254 events40 affected175 at risk EG003
Administration site erythema	General disorders	v28.1	Systematic Assessment	EG000220 events126 affected188 at risk EG001201 events116 affected179 at risk EG002213 events121 affected175 at risk EG003
Administration site induration	General disorders	v28.1	Systematic Assessment	EG000253 events139 affected188 at risk EG001209 events118 affected179 at risk EG002259 events137 affected175 at risk EG003
Administration site pain	General disorders	v28.1	Systematic Assessment	EG000255 events143 affected188 at risk EG001230 events127 affected179 at risk EG002213 events125 affected175 at risk EG003
Administration site swelling	General disorders	v28.1	Systematic Assessment	EG000172 events100 affected188 at risk EG001153 events87 affected179 at risk EG002158 events96 affected175 at risk EG003
Catheter site dermatitis	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Crying	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Discomfort	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events2 affected179 at risk EG0028 events4 affected175 at risk EG003
Injection site bruising	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Injection site discolouration	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Injection site induration	General disorders	v28.1	Systematic Assessment	EG0007 events7 affected188 at risk EG0014 events4 affected179 at risk EG0028 events6 affected175 at risk EG003
Injection site mass	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Injection site swelling	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Malaise	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Pyrexia	General disorders	v28.1	Systematic Assessment	EG000145 events88 affected188 at risk EG001140 events85 affected179 at risk EG002115 events73 affected175 at risk EG003
Vaccination site reaction	General disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Food allergy	Immune system disorders	v28.1	Systematic Assessment	EG0004 events4 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Hypersensitivity	Immune system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Milk allergy	Immune system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0024 events3 affected175 at risk EG003
Abscess limb	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Abscess neck	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Acute sinusitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Amoebic dysentery	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Anal candidiasis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Blastocystis infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Body tinea	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0013 events3 affected179 at risk EG0020 events0 affected175 at risk EG003
Bronchiolitis	Infections and infestations	v28.1	Systematic Assessment	EG00017 events13 affected188 at risk EG00121 events15 affected179 at risk EG00216 events12 affected175 at risk EG003
Bronchitis	Infections and infestations	v28.1	Systematic Assessment	EG00015 events11 affected188 at risk EG00127 events15 affected179 at risk EG00220 events13 affected175 at risk EG003
COVID-19	Infections and infestations	v28.1	Systematic Assessment	EG00011 events11 affected188 at risk EG00111 events11 affected179 at risk EG0027 events7 affected175 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Candida infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Candida nappy rash	Infections and infestations	v28.1	Systematic Assessment	EG0004 events4 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Conjunctivitis	Infections and infestations	v28.1	Systematic Assessment	EG00030 events23 affected188 at risk EG00128 events22 affected179 at risk EG00223 events18 affected175 at risk EG003
Conjunctivitis bacterial	Infections and infestations	v28.1	Systematic Assessment	EG0005 events5 affected188 at risk EG0014 events4 affected179 at risk EG0021 events1 affected175 at risk EG003
Coronavirus infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Croup infectious	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Dacryocystitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Dermatitis infected	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Dysentery	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Ear infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0023 events3 affected175 at risk EG003
Eczema impetiginous	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Enterovirus infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Erythema infectiosum	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Exanthema subitum	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0021 events1 affected175 at risk EG003
Eye infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Febrile infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Folliculitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Fungal infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Fungal skin infection	Infections and infestations	v28.1	Systematic Assessment	EG0003 events3 affected188 at risk EG0013 events2 affected179 at risk EG0023 events3 affected175 at risk EG003
Furuncle	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Gastroenteritis	Infections and infestations	v28.1	Systematic Assessment	EG00039 events26 affected188 at risk EG00130 events24 affected179 at risk EG00237 events29 affected175 at risk EG003
Gastroenteritis Escherichia coli	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Gastroenteritis viral	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Gianotti-Crosti syndrome	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Giardiasis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	v28.1	Systematic Assessment	EG0006 events6 affected188 at risk EG0017 events6 affected179 at risk EG00210 events10 affected175 at risk EG003
Herpangina	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0013 events3 affected179 at risk EG0023 events2 affected175 at risk EG003
Herpes simplex	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Impetigo	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0013 events3 affected179 at risk EG0021 events1 affected175 at risk EG003
Infection parasitic	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Influenza	Infections and infestations	v28.1	Systematic Assessment	EG0004 events4 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Laryngitis	Infections and infestations	v28.1	Systematic Assessment	EG0008 events6 affected188 at risk EG00113 events8 affected179 at risk EG00212 events10 affected175 at risk EG003
Laryngitis viral	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Latent tuberculosis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Lower respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG00016 events14 affected188 at risk EG0015 events5 affected179 at risk EG00211 events9 affected175 at risk EG003
Mycoplasma infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Nasopharyngitis	Infections and infestations	v28.1	Systematic Assessment	EG00043 events29 affected188 at risk EG00154 events30 affected179 at risk EG00221 events16 affected175 at risk EG003
Norovirus infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Onychomycosis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Oral candidiasis	Infections and infestations	v28.1	Systematic Assessment	EG0007 events6 affected188 at risk EG0014 events4 affected179 at risk EG0025 events5 affected175 at risk EG003
Oral herpes	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0013 events3 affected179 at risk EG0021 events1 affected175 at risk EG003
Otitis externa	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0014 events3 affected179 at risk EG0022 events1 affected175 at risk EG003
Otitis media	Infections and infestations	v28.1	Systematic Assessment	EG00012 events10 affected188 at risk EG00122 events16 affected179 at risk EG00217 events13 affected175 at risk EG003
Otitis media acute	Infections and infestations	v28.1	Systematic Assessment	EG00013 events9 affected188 at risk EG00122 events17 affected179 at risk EG00220 events12 affected175 at risk EG003
Otitis media chronic	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Parasitic gastroenteritis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Paronychia	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Periorbital cellulitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Pharyngitis	Infections and infestations	v28.1	Systematic Assessment	EG0005 events3 affected188 at risk EG0014 events4 affected179 at risk EG0025 events4 affected175 at risk EG003
Pharyngitis bacterial	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Pharyngitis streptococcal	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Pharyngotonsillitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Pneumonia	Infections and infestations	v28.1	Systematic Assessment	EG0004 events3 affected188 at risk EG0014 events4 affected179 at risk EG0023 events3 affected175 at risk EG003
Pneumonia viral	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Pulmonary tuberculosis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Pyoderma	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Rash pustular	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	v28.1	Systematic Assessment	EG0003 events3 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG00027 events14 affected188 at risk EG00111 events8 affected179 at risk EG00218 events14 affected175 at risk EG003
Respiratory tract infection bacterial	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Respiratory tract infection viral	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Rhinitis	Infections and infestations	v28.1	Systematic Assessment	EG0009 events6 affected188 at risk EG0011 events1 affected179 at risk EG0029 events6 affected175 at risk EG003
Roseola	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Scabies	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Scarlet fever	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Sinusitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Skin bacterial infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Skin candida	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Skin infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Streptococcal infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Subcutaneous abscess	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Subglottic laryngitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Suspected COVID-19	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Tinea capitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Tinea faciei	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Tinea versicolour	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Tonsillitis	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0012 events2 affected179 at risk EG0025 events5 affected175 at risk EG003
Tracheitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Tracheobronchitis	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Upper respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG00080 events43 affected188 at risk EG00157 events31 affected179 at risk EG002111 events48 affected175 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Urinary tract infection	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0014 events3 affected179 at risk EG0025 events5 affected175 at risk EG003
Urinary tract infection viral	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Varicella	Infections and infestations	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Varicella zoster virus infection	Infections and infestations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Viral diarrhoea	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Viral infection	Infections and infestations	v28.1	Systematic Assessment	EG00013 events9 affected188 at risk EG0016 events5 affected179 at risk EG0028 events7 affected175 at risk EG003
Viral pharyngitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Viral rash	Infections and infestations	v28.1	Systematic Assessment	EG0004 events3 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Viral skin infection	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Viral tonsillitis	Infections and infestations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	v28.1	Systematic Assessment	EG00033 events18 affected188 at risk EG00141 events16 affected179 at risk EG00221 events9 affected175 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Concussion	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Contusion	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0003 events3 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Exposure to communicable disease	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Fall	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0002 events1 affected188 at risk EG0011 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Foreign body in eye	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Foreign body in mouth	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Head injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0002 events1 affected188 at risk EG0014 events4 affected179 at risk EG0025 events5 affected175 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Limb injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events2 affected179 at risk EG0021 events1 affected175 at risk EG003
Mouth injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Nail injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Nasal injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Wound	Injury, poisoning and procedural complications	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Activated partial thromboplastin time shortened	Investigations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Cardiac murmur	Investigations	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Coagulation test abnormal	Investigations	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Dairy intolerance	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG000128 events89 affected188 at risk EG001107 events82 affected179 at risk EG00290 events61 affected175 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Food intolerance	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events2 affected179 at risk EG0020 events0 affected175 at risk EG003
Malnutrition	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Underweight	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Weight gain poor	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Zinc deficiency	Metabolism and nutrition disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Growth retardation	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Infantile postural asymmetry	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Infantile haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Epilepsy	Nervous system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Febrile convulsion	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Hydrocephalus	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Hypertonia	Nervous system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Hypotonia	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Hypotonic-hyporesponsive episode	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Movement disorder	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Muscle contractions involuntary	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Nystagmus	Nervous system disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Psychomotor skills impaired	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Seizure	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Somnolence	Nervous system disorders	v28.1	Systematic Assessment	EG000181 events111 affected188 at risk EG001176 events120 affected179 at risk EG002146 events89 affected175 at risk EG003
Tremor	Nervous system disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Umbilical granuloma	Pregnancy, puerperium and perinatal conditions	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Apathy	Psychiatric disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Behaviour disorder	Psychiatric disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Breath holding	Psychiatric disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Initial insomnia	Psychiatric disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Insomnia	Psychiatric disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Irritability	Psychiatric disorders	v28.1	Systematic Assessment	EG000292 events158 affected188 at risk EG001276 events152 affected179 at risk EG002253 events144 affected175 at risk EG003
Poor quality sleep	Psychiatric disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Psychomotor retardation	Psychiatric disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Sleep terror	Psychiatric disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Pyelocaliectasis	Renal and urinary disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Breast mass	Reproductive system and breast disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Genital labial adhesions	Reproductive system and breast disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Aphonia	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0008 events5 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0007 events5 affected188 at risk EG0013 events3 affected179 at risk EG00210 events10 affected175 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0006 events6 affected188 at risk EG0012 events1 affected179 at risk EG0025 events4 affected175 at risk EG003
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0024 events4 affected175 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Blister	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0022 events2 affected175 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0006 events6 affected188 at risk EG0016 events6 affected179 at risk EG0027 events7 affected175 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0021 events1 affected175 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0005 events5 affected188 at risk EG0016 events6 affected179 at risk EG0025 events5 affected175 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0013 events3 affected179 at risk EG0021 events1 affected175 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG00016 events15 affected188 at risk EG00119 events13 affected179 at risk EG0028 events6 affected175 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG00011 events10 affected188 at risk EG00111 events9 affected179 at risk EG0025 events5 affected175 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0021 events1 affected175 at risk EG003
Lipohypertrophy	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0002 events2 affected188 at risk EG0011 events1 affected179 at risk EG0020 events0 affected175 at risk EG003
Papulopustular rosacea	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Pityriasis alba	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0003 events2 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Rash	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG00010 events8 affected188 at risk EG00113 events11 affected179 at risk EG0027 events7 affected175 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0021 events1 affected175 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected179 at risk EG0023 events3 affected175 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	v28.1	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected179 at risk EG0022 events2 affected175 at risk EG003
Pallor	Vascular disorders	v28.1	Systematic Assessment	EG0000 events0 affected188 at risk EG0010 events0 affected179 at risk EG0020 events0 affected175 at risk EG003

First MCP Posted Date

ID	Term
D008589	Meningococcal Infections

ID	Term
D014612	Vaccines
C570015	4CMenB vaccine
C576777	tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.

Title	Measurements
	OG00088.2(79.4 to 94.2) OG00188.2(78.1 to 94.8) OG00282.1(70.8 to 90.4) OG00396.1(89.0 to 99.2)

Title	Measurements
	OG00095.3(88.5 to 98.7) OG00192.9(84.1 to 97.6) OG00242.0(30.2 to 54.5) OG00368.4(56.9 to 78.4)

Title	Measurements
	OG00094.2(87.0 to 98.1) OG00185.7(75.3 to 92.9) OG00284.3(73.6 to 91.9) OG00382.3(72.1 to 90.0)

Title	Measurements
	OG00078.1(60.0 to 90.7) OG00178.8(61.1 to 91.0) OG00213.3(3.8 to 30.7) OG00321.7(7.5 to 43.7)

Title	Measurements
	OG00094.6(81.8 to 99.3) OG00191.7(77.5 to 98.2) OG0023.3(0.1 to 17.2) OG0033.8(0.1 to 19.6)

Title	Measurements
	OG00091.9(78.1 to 98.3) OG001100(90.3 to 100) OG0026.7(0.8 to 22.1) OG0033.8(0.1 to 19.6)

Title	Measurements
	OG0009.0(3.4 to 18.5) OG00113.7(6.8 to 23.8) OG00218.5(9.9 to 30.0) OG00318.3(10.1 to 29.3)

Title	Measurements
	OG0009.3(3.8 to 18.3) OG00113.3(6.6 to 23.2) OG0022.7(0.3 to 9.5) OG0031.3(0.0 to 6.9)

Title	Measurements
	OG0008.0(3.0 to 16.6) OG0018.0(3.0 to 16.6) OG0028.1(3.0 to 16.8) OG0033.8(0.8 to 10.8)

Title	Measurements
	OG0003.0(0.1 to 15.8) OG0016.5(0.8 to 21.4) OG0029.7(2.0 to 25.8) OG0034.0(0.1 to 20.4)

Title	Measurements
	OG0000.0(0.0 to 0.0) OG0010.0(0.0 to 0.0) OG0020.0(0.0 to 0.0) OG0030.0(0.0 to 0.0)

Title	Measurements
	OG0000.0(0.0 to 0.0) OG0010.0(0.0 to 0.0) OG0026.5(0.8 to 21.4) OG0030.0(0.0 to 0.0)

Title	Measurements
	OG00088.6(78.7 to 94.9) OG00191.4(82.3 to 96.8) OG00291.3(82.0 to 96.7) OG00398.6(92.6 to 100)

Title	Measurements
	OG000100(95.3 to 100) OG001100(95.1 to 100) OG00283.1(72.3 to 91.0) OG00392.1(83.6 to 97.0)

Title	Measurements
	OG00096.0(88.8 to 99.2) OG00197.3(90.5 to 99.7) OG00279.2(68.0 to 87.8) OG00388.2(78.7 to 94.4)

Title	Measurements
	OG00090.6(75.0 to 98.0) OG00196.0(79.6 to 99.9) OG00234.5(17.9 to 54.3) OG00365.2(42.7 to 83.6)

Title	Measurements
	OG00085.3(68.9 to 95.0) OG00192.6(75.7 to 99.1) OG0026.9(0.8 to 22.8) OG0038.3(1.0 to 27.0)

Title	Measurements
	OG00085.3(68.9 to 95.0) OG00192.6(75.7 to 99.1) OG00220.7(8.0 to 39.7) OG00316.7(4.7 to 37.4)

Title	Measurements
	OG00065.6(48.1 to 89.4) OG00179.9(56.3 to 113.5) OG00265.7(46.1 to 93.8) OG003148.3(105.4 to 208.8)

Title	Measurements
	OG00045.4(37.4 to 55.2) OG00145.4(36.5 to 56.6) OG0024.5(3.6 to 5.7) OG0037.5(6.1 to 9.3)

Title	Measurements
	OG00015.0(11.9 to 18.8) OG00114.3(11.1 to 18.5) OG0026.4(5.0 to 8.3) OG0038.6(6.7 to 11.1)

Title	Measurements
	OG00039.5(24.6 to 63.4) OG00136.2(23.4 to 55.9) OG0023.8(2.3 to 6.1) OG0033.9(2.3 to 6.7)

Title	Measurements
	OG00017.4(13.6 to 22.2) OG00117.4(13.7 to 22.1) OG0022.1(1.6 to 2.8) OG0032.0(1.5 to 2.7)

Title	Measurements
	OG00023.1(17.6 to 30.4) OG00123.1(17.7 to 30.2) OG0021.5(1.1 to 2.1) OG0031.5(1.1 to 2.1)

Title	Measurements
	OG0004.5(3.4 to 5.9) OG0015.6(4.3 to 7.2) OG0026.8(5.2 to 8.9) OG0036.6(5.0 to 8.5)

Title	Measurements
	OG0004.0(3.5 to 4.5) OG0014.2(3.7 to 4.8) OG0023.5(3.0 to 4.0) OG0033.4(2.9 to 3.8)

Title	Measurements
	OG0002.9(2.6 to 3.2) OG0012.7(2.4 to 2.9) OG0022.8(2.5 to 3.1) OG0032.6(2.4 to 2.8)

Title	Measurements
	OG0003.2(3.0 to 3.5) OG0013.3(3.1 to 3.6) OG0023.4(3.2 to 3.7) OG0033.1(2.8 to 3.4)

Title	Measurements
	OG0002.5(2.5 to 2.5) OG0012.5(2.5 to 2.5) OG0022.5(2.5 to 2.5) OG0032.5(2.5 to 2.5)

Title	Measurements
	OG0002.0(1.6 to 2.3) OG0012.0(1.7 to 2.3) OG0022.4(2.0 to 2.9) OG0032.0(1.7 to 2.5)

Title	Measurements
	OG000277.4(182.7 to 421.1) OG001417.2(272.1 to 639.9) OG002395.2(252.9 to 617.6) OG003816.3(525.4 to 1268.5)

Title	Measurements
	OG00070.8(57.8 to 86.7) OG00183.2(67.5 to 102.6) OG00213.2(10.6 to 16.4) OG00321.2(17.1 to 26.2)

Title	Measurements
	OG00030.3(22.5 to 40.7) OG00134.0(25.1 to 46.1) OG00211.4(8.3 to 15.7) OG00318.9(13.9 to 25.8)

Title	Measurements
	OG000116.1(71.9 to 187.5) OG001144.5(87.2 to 239.4) OG0027.5(4.6 to 12.3) OG00318.7(10.7 to 32.6)

Title	Measurements
	OG00019.3(13.9 to 26.8) OG00122.5(15.8 to 31.9) OG0022.8(2.0 to 4.0) OG0033.0(2.0 to 4.4)

Title	Measurements
	OG00023.1(15.1 to 35.4) OG00139.2(24.9 to 61.9) OG0023.7(2.3 to 5.8) OG0033.0(1.8 to 4.9)

Title	Measurements
	OG00044.1(27.0 to 72.0) OG00159.6(37.0 to 96.0) OG00245.2(27.2 to 75.0) OG003100.7(61.3 to 165.4)

Title	Measurements
	OG00016.6(13.5 to 20.3) OG00119.3(15.7 to 23.8) OG0023.6(2.9 to 4.4) OG0036.3(5.2 to 7.8)

Title	Measurements
	OG0009.8(7.2 to 13.2) OG00112.2(9.0 to 16.5) OG0024.2(3.1 to 5.7) OG0037.2(5.3 to 9.8)

Title	Measurements
	OG00037.8(22.3 to 64.1) OG00141.3(24.5 to 69.4) OG0022.2(1.3 to 3.7) OG0036.2(3.5 to 10.9)

Title	Measurements
	OG0008.1(5.7 to 11.6) OG0018.7(6.0 to 12.7) OG0021.2(0.8 to 1.7) OG0031.2(0.8 to 1.8)

Title	Measurements
	OG00012.0(7.9 to 18.2) OG00119.9(13.1 to 30.3) OG0021.6(1.1 to 2.5) OG0031.5(0.9 to 2.3)

Title	Measurements
	OG00099.2(95.7 to 100) OG00198.2(93.8 to 99.8) OG00298.2(93.5 to 99.8) OG00398.2(93.6 to 99.8)

Title	Measurements
	OG00099.2(95.8 to 100) OG00199.1(95.2 to 100) OG00298.1(93.5 to 99.8) OG00399.1(95.1 to 100)

Title	Measurements
	OG00086.8(79.7 to 92.1) OG00189.7(82.6 to 94.5) OG00289.8(82.5 to 94.8) OG00396.5(91.3 to 99.0)

Title	Measurements
	OG00044.7(35.4 to 54.3) OG00147.7(38.1 to 57.5) OG00254.1(44.3 to 63.6) OG00384.1(75.8 to 90.5)

Title	Measurements
	OG00044.7(35.4 to 54.3) OG00153.7(43.8 to 63.3) OG00234.5(25.8 to 44.0) OG00393.5(87.1 to 97.4)

Title	Measurements
	OG00024.6(17.0 to 33.5) OG00130.3(21.8 to 39.8) OG00223.0(15.6 to 31.9) OG00388.0(80.3 to 93.4)

Title	Measurements
	OG00099.1(95.2 to 100) OG001100(96.4 to 100) OG00297.2(92.0 to 99.4) OG00399.0(94.7 to 100)

Title	Measurements
	OG000100(96.8 to 100) OG001100(96.4 to 100) OG00298.1(93.4 to 99.8) OG003100(96.4 to 100)

Title	Measurements
	OG00099.1(95.2 to 100) OG001100(96.4 to 100) OG00298.2(93.5 to 99.8) OG003100(96.5 to 100)

Title	Measurements
	OG000277.0(228.9 to 335.3) OG001280.1(228.7 to 342.9) OG002265.5(214.6 to 328.4) OG003233.1(187.9 to 289.1)

Title	Measurements
	OG000388.9(320.5 to 471.8) OG001365.5(296.2 to 451.1) OG002207.8(167.1 to 258.2) OG003226.8(182.3 to 282.0)

Title	Measurements
	OG00051.5(41.7 to 63.7) OG00152.6(42.1 to 65.8) OG00256.7(44.7 to 71.7) OG00394.4(74.7 to 119.3)

Title	Measurements
	OG0007.8(6.4 to 9.6) OG0018.3(6.8 to 10.3) OG0028.1(6.6 to 10.0) OG00325.1(20.2 to 31.2)

Title	Measurements
	OG0008.6(7.0 to 10.7) OG00111.9(9.6 to 14.9) OG0026.8(5.4 to 8.4) OG00354.4(43.3 to 68.3)

Title	Measurements
	OG0006.9(5.8 to 8.1) OG0017.7(6.5 to 9.1) OG0026.5(5.5 to 7.7) OG00335.2(29.6 to 41.9)

Title	Measurements
	OG000511.0(407.0 to 641.6) OG001681.9(536.7 to 866.4) OG002487.3(386.1 to 614.9) OG0031356.6(1060.5 to 1735.3)

Title	Measurements
	OG000975.4(810.2 to 1174.3) OG0011260.8(1034.6 to 1536.6) OG002652.0(537.8 to 790.4) OG0031826.0(1488.2 to 2240.5)

Title	Measurements
	OG000522.6(419.5 to 651.0) OG001601.6(476.5 to 759.6) OG002485.7(387.7 to 608.5) OG0031230.2(969.3 to 1561.3)

Title	Measurements
	OG00063.7(50.5 to 80.3) OG00185.3(66.9 to 108.7) OG00262.1(49.0 to 78.6) OG00354.7(42.7 to 70.2)

Title	Measurements
	OG000113.6(90.5 to 142.5) OG001109.3(86.1 to 138.8) OG002102.4(81.3 to 128.9) OG00336.5(28.6 to 46.6)

Title	Measurements
	OG00076.3(60.9 to 95.7) OG00182.8(65.4 to 104.8) OG00278.2(62.3 to 98.2) OG00337.0(29.1 to 47.0)

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

ID	Term
D001688	Biological Products
D045424	Complex Mixtures