Trial Outcomes & Findings for Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks (NCT NCT03954743)

NCT ID: NCT03954743

Last Updated: 2022-03-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1351 participants
• Primary outcome timeframe: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
• Results posted on: 2022-03-10

Participant Flow

The study was conducted in 5 countries/regions (Canada, Hong Kong, Taiwan, Turkey and United States).

All 1351 participants enrolled in the study, received a study vaccination and were included in the Exposed Set.

Participant milestones

Measure	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.	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.
Overall Study STARTED	677	674
Overall Study COMPLETED	653	657
Overall Study NOT COMPLETED	24	17

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	6	4
Overall Study Protocol Violation	1	0
Overall Study CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT	13	12
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	3	1

Baseline Characteristics

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Baseline characteristics by cohort

Measure	HRV PCV-free Liq Group n=677 Participants 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.	HRV Lyo Group n=674 Participants 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.	Total n=1351 Participants Total of all reporting groups
Age, Continuous	9.0 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants	9.0 Weeks STANDARD_DEVIATION 1.5 • n=7 Participants	9.0 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	336 Participants n=5 Participants	357 Participants n=7 Participants	693 Participants n=5 Participants
Sex: Female, Male Male	341 Participants n=5 Participants	317 Participants n=7 Participants	658 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	302 Participants n=5 Participants	301 Participants n=7 Participants	603 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other, Not specified	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized White	339 Participants n=5 Participants	346 Participants n=7 Participants	685 Participants n=5 Participants

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	HRV PCV-free Liq Group n=677 Participants 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.	HRV Lyo Group n=674 Participants 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.
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Cough / Runny Nose, Any	139 Participants	166 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Diarrhea, Any	41 Participants	47 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Fever, ≥ 38.0°C	27 Participants	21 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Irritability / Fussiness, Any	431 Participants	428 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Loss of appetite, Any	201 Participants	186 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination Vomiting, Any	113 Participants	122 Participants

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	HRV PCV-free Liq Group n=663 Participants 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.	HRV Lyo Group n=657 Participants 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.
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Cough / Runny Nose, Any	147 Participants	145 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Irritability / Fussiness, Any	368 Participants	362 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Vomiting, Any	82 Participants	88 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Diarrhea, Any	28 Participants	36 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Fever, ≥ 38.0°C	46 Participants	40 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination Loss of appetite, Any	170 Participants	168 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	HRV PCV-free Liq Group n=677 Participants 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.	HRV Lyo Group n=674 Participants 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.
Number of Subjects With Any Unsolicited AEs	201 Participants	206 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	HRV PCV-free Liq Group n=677 Participants 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.	HRV Lyo Group n=674 Participants 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.
Number of Subjects With Any Serious Adverse Events (SAEs)	39 Participants	38 Participants

Adverse Events

HRV PCV-free Liq Group

Serious events: 39 serious events

Other events: 591 other events

Deaths: 0 deaths

HRV Lyo Group

Serious events: 38 serious events

Other events: 571 other events

Deaths: 0 deaths

Serious adverse events

Measure	HRV PCV-free Liq Group n=677 participants at risk 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.	HRV Lyo Group n=674 participants at risk 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.
Congenital, familial and genetic disorders Osteogenesis imperfecta	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Congenital, familial and genetic disorders Scaphocephaly	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Constipation	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Vomiting	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Pyrexia	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Adenovirus infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Bronchiolitis	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Bronchitis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Cellulitis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Citrobacter infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Croup infectious	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Enterovirus infection	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Escherichia infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Escherichia urinary tract infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Exanthema subitum	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis enteroviral	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis norovirus	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis salmonella	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis viral	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Human bocavirus infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Influenza	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Meningitis	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Meningitis streptococcal	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Metapneumovirus infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Parainfluenzae virus infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Picornavirus infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Pneumonia	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Pyelonephritis acute	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.74% 5/677 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Rhinovirus infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Roseola	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Streptococcal sepsis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Upper respiratory tract infection	0.74% 5/677 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.89% 6/674 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Urinary tract infection	0.89% 6/677 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Urosepsis	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Viral infection	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Viral rash	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Injury, poisoning and procedural complications Ear canal abrasion	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Injury, poisoning and procedural complications Head injury	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Metabolism and nutrition disorders Lactose intolerance	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Nervous system disorders Febrile convulsion	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Nervous system disorders Haemorrhage intracranial	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Eczema	0.30% 2/677 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Vascular disorders Kawasaki's disease	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).

Other adverse events

Measure	HRV PCV-free Liq Group n=677 participants at risk 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.	HRV Lyo Group n=674 participants at risk 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.
Infections and infestations Pustule	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Respiratory tract infection	6.9% 47/677 • Number of events 52 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	6.8% 46/674 • Number of events 53 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Rhinovirus infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Skin infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Tinea barbae	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Tinea capitis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Congenital, familial and genetic disorders Ankyloglossia congenital	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Congenital, familial and genetic disorders Buried penis syndrome	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Congenital, familial and genetic disorders Developmental hip dysplasia	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Congenital, familial and genetic disorders Hydrocele	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Ear and labyrinth disorders Ear pain	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Eye disorders Blepharitis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Eye disorders Dacryostenosis acquired	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Eye disorders Eye discharge	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Eye disorders Keratitis	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Abdominal distension	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Abdominal pain	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Abnormal faeces	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Anal fissure	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Change of bowel habit	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Constipation	1.5% 10/677 • Number of events 10 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Diarrhoea	9.0% 61/677 • Number of events 76 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	12.0% 81/674 • Number of events 100 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Eructation	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Faeces discoloured	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Flatulence	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.0% 7/674 • Number of events 7 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.74% 5/677 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Haematochezia	0.30% 2/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Infantile colic	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Infantile spitting up	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Infrequent bowel movements	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Mucous stools	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Salivary hypersecretion	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Teething	1.0% 7/677 • Number of events 9 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.0% 7/674 • Number of events 8 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Gastrointestinal disorders Vomiting	22.6% 153/677 • Number of events 198 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	25.2% 170/674 • Number of events 219 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Discomfort	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Face oedema	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Fatigue	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Ill-defined disorder	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Injection site pain	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Irritability postvaccinal	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Pain	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Pyrexia	13.6% 92/677 • Number of events 103 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	10.4% 70/674 • Number of events 79 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Swelling	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Swelling face	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
General disorders Vaccination site pain	0.74% 5/677 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Immune system disorders Milk allergy	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Bronchiolitis	1.2% 8/677 • Number of events 8 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.3% 9/674 • Number of events 9 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Bronchitis	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Candida nappy rash	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Conjunctivitis	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.0% 7/674 • Number of events 7 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Conjunctivitis viral	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Croup infectious	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Ear infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Enterovirus infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Fungal skin infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Gastroenteritis viral	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Hordeolum	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Influenza	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Nasopharyngitis	4.4% 30/677 • Number of events 31 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	3.3% 22/674 • Number of events 24 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Omphalitis	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Oral candidiasis	0.44% 3/677 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Otitis externa	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Otitis media	1.2% 8/677 • Number of events 9 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Otitis media acute	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Paronychia	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Pharyngitis	0.89% 6/677 • Number of events 7 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Pneumonia viral	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Tonsillitis	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Upper respiratory tract infection	3.8% 26/677 • Number of events 31 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	5.0% 34/674 • Number of events 35 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Urinary tract infection	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Viral rash	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Viral upper respiratory tract infection	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Injury, poisoning and procedural complications Arthropod bite	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Injury, poisoning and procedural complications Vaccination complication	1.0% 7/677 • Number of events 7 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.3% 9/674 • Number of events 9 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Investigations Body temperature increased	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Investigations Cardiac murmur	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Investigations Weight decreased	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Metabolism and nutrition disorders Decreased appetite	42.8% 290/677 • Number of events 371 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	38.7% 261/674 • Number of events 361 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Metabolism and nutrition disorders Increased appetite	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Musculoskeletal and connective tissue disorders Acquired plagiocephaly	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Nervous system disorders Lethargy	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Nervous system disorders Somnolence	0.30% 2/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.74% 5/674 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Pregnancy, puerperium and perinatal conditions Weight decrease neonatal	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Psychiatric disorders Irritability	75.6% 512/677 • Number of events 812 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	72.3% 487/674 • Number of events 796 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Asthma	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Cough	35.6% 241/677 • Number of events 295 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	35.5% 239/674 • Number of events 323 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.74% 5/677 • Number of events 5 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Productive cough	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.5% 10/674 • Number of events 12 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Respiratory, thoracic and mediastinal disorders Wheezing	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dermatitis	0.30% 2/677 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.89% 6/677 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.30% 2/674 • Number of events 2 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dermatitis contact	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dermatitis diaper	0.89% 6/677 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.74% 5/674 • Number of events 6 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Dry skin	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Eczema	2.4% 16/677 • Number of events 17 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.2% 8/674 • Number of events 8 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Eczema infantile	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.00% 0/674 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Erythema	0.15% 1/677 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Rash	1.5% 10/677 • Number of events 11 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	1.3% 9/674 • Number of events 9 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.59% 4/674 • Number of events 4 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.44% 3/677 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.45% 3/674 • Number of events 3 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
Infections and infestations Suspected COVID-19	0.00% 0/677 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).	0.15% 1/674 • Number of events 1 • Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER