Evaluation of Immunogenicity and Safety of Two Formulatio... | NCT02914184

ID	Type	Description	Link
2016-000598-19	EudraCT Number

Label	Type	Description	Intervention Names
Liq_A Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age	Biological: HRV PCV-free liquid vaccine
Liq_B Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age	Biological: HRV PCV-free liquid vaccine
Liq_C Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age	Biological: HRV PCV-free liquid vaccine
Lyo Group	Active Comparator	All subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age	Biological: Rotarix

Name	Type	Description	Arm Group Labels	Other Names
HRV PCV-free liquid vaccine	Biological	Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally	Liq_A Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)	Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).	At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group	Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.	At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group	Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)	Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL, 1-2 months after Dose 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Child in care
Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of long-acting immune-modifying drugs at any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
History of IS.
Family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Major congenital defects or serious chronic illness.
Previous vaccination against RV.
Previous confirmed occurrence of RVGE.
GE within 7 days preceding the study vaccine administration.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35235	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
32365189	Background	Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, Garcia-Sicilia J, Cespedes J, Abdelnour A, Tamura T, Kuroki H, Chiu NC, Virta M, Kokko S, Horn M, Panzer F, Kim JH, Jin L, Moerman L, Debacq C, Parra J, Ugarte A, Bi D; Rota-081 Study Group. Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. J Infect Dis. 2020 May 4;225(12):2106-15. doi: 10.1093/infdis/jiaa210. Online ahead of print.

ID	Title	Description
FG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
FG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 9, 2017	Aug 1, 2019

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

Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)

Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).

The analysis was performed on the Per-protocol analysis set (PPS) for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.

Posted

Geometric Mean

95% Confidence Interval

U/mL

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
OG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.

Units	Counts
Participants	OG000332 OG001326 OG002326

Title

Denominators

Categories

Title	Measurements
	OG000155.7(125.6 to 193.1) OG001147.3(118.4 to 183.3) OG002175.9(142.8 to 216.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	GMC Ratio of Anti-RV IgA antibody for Liq_A and Liq_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.	ANOVA				GMC Ratio at At Month 2-4	1.07			2-Sided	95	0.79	1.44					Other	The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the [0.5; 2] clinical limit interval.

Primary

Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group

Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA).

For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.

The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_Pool Group	Subjects who received two doses of PCV-free HRV liquid formulation of pooled lot A, B and C at 6 and 12 weeks of age.

Primary

Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group

The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group

Primary

Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group

Antibody concentrations against RV were determined as GMCs and expressed as U/mL.

Posted

Geometric Mean

95% Confidence Interval

U/mL

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_Pool Group	Subjects who received two doses of PCV-free HRV liquid formulation of pooled lot A, B and C at 6 and 12 weeks of age.
OG001	Lyo Control Group	Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.

Primary

Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group

Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.

Posted

Geometric Mean

95% Confidence Interval

U/mL

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
OG002	Liq_C Group

Secondary

Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)

Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.

For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL, 1-2 months after Dose 2

Posted

Number

95% Confidence Interval

Percentage of subjects

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_Pool Group	Subjects who received two doses of PCV-free HRV liquid formulation of pooled lot A, B and C at 6 and 12 weeks of age.
OG001	Lyo Control Group

Secondary

Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups)

Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the individual HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. The analysis was performed to assess the immunogenicity of the PCV-free liquid HRV vaccine (pooled HRV liquid groups) and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL 1-2 months after Dose 2.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.

Secondary

Number of Subjects With Any Solicited General Adverse Events (AEs).

Assessed solicited general AEs were cough/runny nose, diarrhea, fever (defined as temperature ≥ 38.0°C), irritability/fussiness, loss of appetite and vomiting. Any solicited general AE is defined as any occurrence of the specified symptom, irrespective of intensity grade and relationship to vaccination.

Analysis was performed on the Exposed Set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.

Posted

Count of Participants

Participants

During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
OG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.

Secondary

Number of Subjects With Any Unsolicited AEs.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination.

Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.

Posted

Count of Participants

Participants

During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination across doses

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
OG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.

Posted

Count of Participants

Participants

During the entire study period (Day 1 to Month 7-8)

ID	Title	Description
OG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
OG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
OG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
OG003	Lyo Control Group

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abscess jaw	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG0030 events0 affected402 at risk
Acute sinusitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Allergic gastroenteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Bronchiolitis	Infections and infestations	Systematic Assessment	EG0004 events4 affected400 at risk EG0013 events3 affected396 at risk EG0024 events3 affected402 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0022 events2 affected402 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0023 events1 affected402 at risk EG003
Encephalitis enteroviral	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Infantile colic	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Infantile spasms	Nervous system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Intussusception	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Meningitis haemophilus	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Metapneumovirus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Milk allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Myelitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Neuroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Otitis media	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Otitis media acute	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0013 events3 affected396 at risk EG0020 events0 affected402 at risk EG003
Otitis media chronic	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Pneumococcal sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0021 events1 affected402 at risk EG003
Pneumonia pneumococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	Systematic Assessment	EG0006 events6 affected400 at risk EG0016 events6 affected396 at risk EG0023 events3 affected402 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Staphylococcal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Subdural hygroma	Nervous system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0002 events1 affected400 at risk EG0010 events0 affected396 at risk EG0023 events3 affected402 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Vulval abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG0030 events0 affected402 at risk
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Ankyloglossia congenital	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Brachycephaly	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Craniosynostosis	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Developmental hip dysplasia	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Gray matter heterotopia	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Plagiocephaly	Congenital, familial and genetic disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Trisomy 21	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Blepharitis	Eye disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Dacryostenosis acquired	Eye disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Eye allergy	Eye disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Eye discharge	Eye disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Lacrimation increased	Eye disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Ocular hyperaemia	Eye disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0007 events6 affected400 at risk EG0013 events3 affected396 at risk EG0025 events5 affected402 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Abnormal faeces	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Aerophagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0008 events6 affected400 at risk EG00110 events10 affected396 at risk EG0025 events4 affected402 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00057 events38 affected400 at risk EG00125 events25 affected396 at risk EG00245 events31 affected402 at risk EG003
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Eructation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0007 events5 affected400 at risk EG0013 events3 affected396 at risk EG0025 events4 affected402 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG00010 events10 affected400 at risk EG0019 events9 affected396 at risk EG0024 events4 affected402 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0023 events3 affected402 at risk EG003
Infantile colic	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0012 events2 affected396 at risk EG0022 events2 affected402 at risk EG003
Mucous stools	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Perianal erythema	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Post-tussive vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Regurgitation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0022 events2 affected402 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Teething	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0014 events4 affected396 at risk EG0023 events3 affected402 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0007 events7 affected400 at risk EG0016 events6 affected396 at risk EG0023 events3 affected402 at risk EG003
Crying	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Discomfort	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Injection site induration	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Injection site mass	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Injection site pain	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Injection site swelling	General disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Pain	General disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0013 events3 affected396 at risk EG0020 events0 affected402 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG00010 events10 affected400 at risk EG0018 events8 affected396 at risk EG00213 events13 affected402 at risk EG003
Vaccination site discomfort	General disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Vaccination site pain	General disorders	Systematic Assessment	EG0003 events3 affected400 at risk EG0011 events1 affected396 at risk EG0022 events1 affected402 at risk EG003
Anaphylactic reaction	Immune system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Immunisation reaction	Immune system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Milk allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Acarodermatitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Acute sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Anal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Anal candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Bronchiolitis	Infections and infestations	Systematic Assessment	EG00010 events10 affected400 at risk EG00110 events10 affected396 at risk EG0027 events7 affected402 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0005 events5 affected400 at risk EG0014 events4 affected396 at risk EG0026 events6 affected402 at risk EG003
Bronchitis bacterial	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Candida infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0013 events3 affected396 at risk EG0021 events1 affected402 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0007 events7 affected400 at risk EG0015 events5 affected396 at risk EG00211 events11 affected402 at risk EG003
Conjunctivitis bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Conjunctivitis viral	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Croup infectious	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Ear infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0013 events3 affected396 at risk EG0023 events3 affected402 at risk EG003
Fungal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Fungal skin infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0020 events0 affected402 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0009 events9 affected400 at risk EG0016 events6 affected396 at risk EG0025 events3 affected402 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Herpangina	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Impetigo	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0004 events4 affected400 at risk EG0014 events4 affected396 at risk EG0022 events2 affected402 at risk EG003
Laryngitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0011 events1 affected396 at risk EG0022 events2 affected402 at risk EG003
Lower respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00025 events24 affected400 at risk EG00125 events25 affected396 at risk EG00240 events36 affected402 at risk EG003
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0003 events3 affected400 at risk EG0012 events2 affected396 at risk EG0023 events3 affected402 at risk EG003
Oral fungal infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Oral herpes	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Otitis media	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0015 events5 affected396 at risk EG0024 events4 affected402 at risk EG003
Otitis media acute	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0013 events3 affected396 at risk EG0021 events1 affected402 at risk EG003
Paronychia	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Pharyngitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0012 events2 affected396 at risk EG0023 events3 affected402 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0003 events2 affected400 at risk EG0018 events8 affected396 at risk EG0024 events4 affected402 at risk EG003
Respiratory tract infection viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Rhinitis	Infections and infestations	Systematic Assessment	EG0005 events3 affected400 at risk EG0017 events7 affected396 at risk EG0026 events6 affected402 at risk EG003
Skin bacterial infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Streptococcal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Subglottic laryngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Tonsillitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Tracheobronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG00033 events31 affected400 at risk EG00134 events34 affected396 at risk EG00236 events31 affected402 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0022 events2 affected402 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0021 events1 affected402 at risk EG003
Viral rash	Infections and infestations	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected400 at risk EG0013 events3 affected396 at risk EG0022 events2 affected402 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Sunburn	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected400 at risk EG0013 events3 affected396 at risk EG0024 events3 affected402 at risk EG003
Body temperature increased	Investigations	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Abnormal weight gain	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Appetite disorder	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG000192 events145 affected400 at risk EG0010 events0 affected396 at risk EG002177 events139 affected402 at risk EG003
Feeding disorder	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Poor feeding infant	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Underweight	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Weight gain poor	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Head deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Drooling	Nervous system disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Febrile convulsion	Nervous system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0022 events2 affected402 at risk EG003
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Irritability	Psychiatric disorders	Systematic Assessment	EG000426 events276 affected400 at risk EG0015 events5 affected396 at risk EG002408 events264 affected402 at risk EG003
Merycism	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Selective eating disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Crystalluria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Penile adhesion	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG000213 events165 affected400 at risk EG0016 events6 affected396 at risk EG002198 events152 affected402 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0016 events6 affected396 at risk EG0022 events2 affected402 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0021 events1 affected402 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0012 events2 affected396 at risk EG0026 events6 affected402 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected400 at risk EG0013 events3 affected396 at risk EG0021 events1 affected402 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Acne infantile	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Asteatosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events6 affected400 at risk EG0013 events3 affected396 at risk EG0023 events3 affected402 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected400 at risk EG0012 events2 affected396 at risk EG0029 events9 affected402 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 events4 affected400 at risk EG0016 events6 affected396 at risk EG00210 events8 affected402 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00010 events9 affected400 at risk EG0013 events3 affected396 at risk EG0028 events8 affected402 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Eczema infantile	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0021 events1 affected402 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Mechanical urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0020 events0 affected402 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0022 events1 affected402 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected400 at risk EG0012 events2 affected396 at risk EG0021 events1 affected402 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0010 events0 affected396 at risk EG0021 events1 affected402 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0022 events2 affected402 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected400 at risk EG0013 events3 affected396 at risk EG0021 events1 affected402 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected396 at risk EG0020 events0 affected402 at risk EG003

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description
BG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.
BG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.
BG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.
BG003	Lyo Control Group	Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liq_A Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	400	21	400	333	400
EG001	Liq_B Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	396	18	396	242	396
EG002	Liq_C Group	Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	402	21	402	338	402
EG003	Lyo Control Group	Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.	402	18	402	338	402