Safety Study of 2 Formulations of GSK's Human Rotavirus (... | NCT03954743

ID	Type	Description	Link
2018-001986-18	EudraCT Number

Label	Type	Description	Intervention Names
HRV PCV-free Liq Group	Experimental	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.	Biological: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine
HRV Lyo group	Active Comparator	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.	Biological: Lyophilized formulation of GSK's oral live attenuated HRV vaccine

Name	Type	Description	Arm Group Labels	Other Names
PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine	Biological	2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

Measure	Description	Time Frame
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination	Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination	Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Number of Subjects With Any Unsolicited AEs	An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.

Exclusion Criteria:

Medical conditions

Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
Very prematurely born infants (born ≤28 weeks of gestation).
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 (no laboratory testing required).
Hypersensitivity to latex.
Major congenital defects or serious chronic illness, as assessed by the investigator.
Previous confirmed occurrence of Rotavirus Gastroenteritis (RV GE).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of Severe combined immunodeficiency (SCID). Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 1), or planned use 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 and ending 30 days after the last dose of study vaccine administration, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) 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.
Previous vaccination against RV. Prior/Concurrent clinical study experience
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 (drug or medical device).

Other exclusions

• Child in care.

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

ID	Title	Description
FG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 30, 2020	May 24, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination

Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.

Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed after the first vaccination.

Posted

Count of Participants

Participants

During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)

ID	Title	Description
OG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
OG001	HRV Lyo Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

Units	Counts
Participants	OG000677 OG001674

Title

Denominators

Categories

Cough / Runny Nose, Any

Title	Measurements
	OG000139 OG001166

Diarrhea, Any

Title	Measurements
	OG000

Primary

Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination

Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed after the second vaccination.

Posted

Count of Participants

Participants

During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)

ID	Title	Description
OG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
OG001	HRV Lyo Group

Primary

Number of Subjects With Any Unsolicited AEs

An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.

Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented.

Posted

Count of Participants

Participants

During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)

ID	Title	Description
OG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
OG001	HRV Lyo Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

Primary

Number of Subjects With Any Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented.

Posted

Count of Participants

Participants

Throughout the study period (from Day 1 up to Month 7 or Month 8)

ID	Title	Description
OG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
OG001	HRV Lyo Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteogenesis imperfecta	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Scaphocephaly	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events3 affected674 at risk
Adenovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Bronchiolitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0012 events2 affected674 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Citrobacter infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Croup infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Enterovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0011 events1 affected674 at risk
Escherichia infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Exanthema subitum	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0013 events3 affected674 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0015 events4 affected674 at risk
Gastroenteritis enteroviral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0010 events0 affected674 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Human bocavirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0012 events2 affected674 at risk
Meningitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Meningitis streptococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0012 events2 affected674 at risk
Picornavirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0013 events3 affected674 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected677 at risk EG0012 events2 affected674 at risk
Rhinovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0012 events2 affected674 at risk
Roseola	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected677 at risk EG0016 events6 affected674 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0006 events6 affected677 at risk EG0014 events4 affected674 at risk
Urosepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0011 events1 affected674 at risk
Viral rash	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Ear canal abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Febrile convulsion	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0006 events2 affected677 at risk EG0012 events1 affected674 at risk
Kawasaki's disease	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ankyloglossia congenital	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0011 events1 affected674 at risk
Buried penis syndrome	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Blepharitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Eye discharge	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events3 affected674 at risk
Abnormal faeces	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0010 events0 affected674 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00010 events10 affected677 at risk EG0013 events3 affected674 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00076 events61 affected677 at risk EG001100 events81 affected674 at risk
Eructation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0017 events7 affected674 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0012 events1 affected674 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected677 at risk EG0013 events3 affected674 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected677 at risk EG0014 events4 affected674 at risk
Infantile colic	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Infantile spitting up	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Infrequent bowel movements	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Teething	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0009 events7 affected677 at risk EG0018 events7 affected674 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000198 events153 affected677 at risk EG001219 events170 affected674 at risk
Discomfort	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Face oedema	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events3 affected674 at risk
Ill-defined disorder	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0012 events2 affected674 at risk
Irritability postvaccinal	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0010 events0 affected674 at risk
Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG000103 events92 affected677 at risk EG00179 events70 affected674 at risk
Swelling	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Swelling face	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Vaccination site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0006 events5 affected677 at risk EG0015 events4 affected674 at risk
Milk allergy	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0013 events3 affected674 at risk
Bronchiolitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0008 events8 affected677 at risk EG0019 events9 affected674 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Candida nappy rash	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0017 events7 affected674 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Croup infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0013 events3 affected674 at risk
Ear infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Enterovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Fungal skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events3 affected674 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0012 events2 affected674 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Hordeolum	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0011 events1 affected674 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00031 events30 affected677 at risk EG00124 events22 affected674 at risk
Omphalitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected677 at risk EG0012 events2 affected674 at risk
Otitis externa	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0009 events8 affected677 at risk EG0013 events3 affected674 at risk
Otitis media acute	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events3 affected674 at risk
Paronychia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0013 events3 affected674 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0007 events6 affected677 at risk EG0012 events2 affected674 at risk
Pneumonia viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Pustule	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00052 events47 affected677 at risk EG00153 events46 affected674 at risk
Rhinovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Tinea barbae	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Tinea capitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00031 events26 affected677 at risk EG00135 events34 affected674 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0012 events2 affected674 at risk
Viral rash	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0012 events2 affected674 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0007 events7 affected677 at risk EG0019 events9 affected674 at risk
Body temperature increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0011 events1 affected674 at risk
Cardiac murmur	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG000371 events290 affected677 at risk EG001361 events261 affected674 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Lethargy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0013 events2 affected674 at risk
Somnolence	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected677 at risk EG0016 events5 affected674 at risk
Weight decrease neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Irritability	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG000812 events512 affected677 at risk EG001796 events487 affected674 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0010 events0 affected674 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG000295 events241 affected677 at risk EG001323 events239 affected674 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected677 at risk EG0014 events4 affected674 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG00112 events10 affected674 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected677 at risk EG0014 events4 affected674 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0006 events6 affected677 at risk EG0012 events2 affected674 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0006 events6 affected677 at risk EG0016 events5 affected674 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00017 events16 affected677 at risk EG0018 events8 affected674 at risk
Eczema infantile	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0010 events0 affected674 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected677 at risk EG0011 events1 affected674 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00011 events10 affected677 at risk EG0019 events9 affected674 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0014 events4 affected674 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected677 at risk EG0013 events3 affected674 at risk
Suspected COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected677 at risk EG0011 events1 affected674 at risk

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

ID	Title	Description
BG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
BG001	HRV Lyo Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HRV PCV-free Liq Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.	0	677	39	677	591	677
EG001	HRV Lyo Group	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.	0	674	38	674	571	674