Trial Outcomes & Findings for Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks (NCT NCT06025695)

NCT ID: NCT06025695

Last Updated: 2025-05-09

Results Overview

Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \[\<\] 20 unit per milliliter \[U/mL\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\>=) 20 U/mL at Month 2 (1-month post-Dose 2).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2000 participants
• Primary outcome timeframe: At Month 2 (1-month post-Dose 2)
• Results posted on: 2025-05-09

Participant Flow

This study was conducted in China.

One participant was randomized to the HRV group but was vaccinated in the HRV PCV-free group. Data for this participant was analyzed in the HRV PCV-free group for all analyses.

Participant milestones

Measure	Human Rotavirus (HRV) Group Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Overall Study STARTED	998	1002
Overall Study COMPLETED	956	967
Overall Study NOT COMPLETED	42	35

Reasons for withdrawal

Measure	Human Rotavirus (HRV) Group Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Overall Study Adverse Event	5	6
Overall Study Migrated / Moved from the Study Area	13	10
Overall Study Other	23	19
Overall Study Adverse Event Requiring Expedited Report	1	0

Baseline Characteristics

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

Baseline characteristics by cohort

Measure	Human Rotavirus (HRV) Group n=998 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=1002 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.	Total n=2000 Participants Total of all reporting groups
Age, Continuous	10.1 WEEKS STANDARD_DEVIATION 2.9 • n=5 Participants	10.2 WEEKS STANDARD_DEVIATION 2.9 • n=7 Participants	10.1 WEEKS STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	455 Participants n=5 Participants	512 Participants n=7 Participants	967 Participants n=5 Participants
Sex: Female, Male Male	543 Participants n=5 Participants	490 Participants n=7 Participants	1033 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN - EAST ASIAN HERITAGE	998 Participants n=5 Participants	1002 Participants n=7 Participants	2000 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 2 (1-month post-Dose 2)

Population: Analysis was performed on Per Protocol Set (PPS), which includes all participants who adhered to the study protocol, ensuring they received no unapproved treatments, remained blinded, had anti-RV concentration \<20 U/mL before intervention, had available anti-RV results at Month 2, complied with blood sampling schedules, and had no concurrent infections. Only participants with data available at specified timepoints were included in the analysis.

Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1-month post-Dose 2).

Outcome measures

Measure	Human Rotavirus (HRV) Group n=865 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=870 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate	88.7 Percentage of participants Interval 86.4 to 90.7	84.9 Percentage of participants Interval 82.4 to 87.3

PRIMARY outcome

Timeframe: At Month 2 (1-month post-Dose 2)

Population: Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.

Outcome measures

Measure	Human Rotavirus (HRV) Group n=865 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=870 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)	222.82 U/mL Interval 198.03 to 250.71	157.31 U/mL Interval 139.31 to 177.64

SECONDARY outcome

Timeframe: At Month 2 (1-month post-Dose 2)

Population: Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.

Outcome measures

Measure	Human Rotavirus (HRV) Group n=865 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=870 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL	69.2 Percentage of participants Interval 66.1 to 72.3	62.9 Percentage of participants Interval 59.6 to 66.1

SECONDARY outcome

Timeframe: Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)

Population: Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.

Solicited systemic events include fever/pyrexia, diarrhoea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Measure	Human Rotavirus (HRV) Group n=973 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=986 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Number of Participants Reporting Solicited Systemic Events Cough/Runny Nose, post vaccination at Day 1	158 Participants	200 Participants
Number of Participants Reporting Solicited Systemic Events Cough/Runny Nose, post vaccination at Month 1	131 Participants	157 Participants
Number of Participants Reporting Solicited Systemic Events Diarrhoea, post vaccination at Day 1	66 Participants	66 Participants
Number of Participants Reporting Solicited Systemic Events Diarrhoea, post vaccination at Month 1	38 Participants	40 Participants
Number of Participants Reporting Solicited Systemic Events Fever/Pyrexia, post vaccination at Day 1	122 Participants	100 Participants
Number of Participants Reporting Solicited Systemic Events Fever/Pyrexia, post vaccination at Month 1	104 Participants	91 Participants
Number of Participants Reporting Solicited Systemic Events Irritability/Fussiness, post vaccination at Day 1	126 Participants	150 Participants
Number of Participants Reporting Solicited Systemic Events Irritability/Fussiness, post vaccination at Month 1	61 Participants	59 Participants
Number of Participants Reporting Solicited Systemic Events Loss of appetite, post vaccination at Day 1	73 Participants	92 Participants
Number of Participants Reporting Solicited Systemic Events Loss of appetite, post vaccination at Month 1	32 Participants	34 Participants
Number of Participants Reporting Solicited Systemic Events Vomiting, post vaccination at Day 1	71 Participants	69 Participants
Number of Participants Reporting Solicited Systemic Events Vomiting, post vaccination at Month 1	30 Participants	36 Participants

SECONDARY outcome

Timeframe: Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)

Population: Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.

Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination

Outcome measures

Measure	Human Rotavirus (HRV) Group n=998 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=1002 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Number of Participants Reporting Unsolicited Adverse Events (AEs) Post-vaccination at Day 1	236 Participants	234 Participants
Number of Participants Reporting Unsolicited Adverse Events (AEs) Post-vaccination at Month 1	223 Participants	229 Participants

SECONDARY outcome

Timeframe: From Day 1 to Month 7

Population: Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom SAE data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.

Outcome measures

Measure	Human Rotavirus (HRV) Group n=998 Participants Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=1002 Participants Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Number of Participants Reporting Serious Adverse Events (SAEs)	251 Participants	262 Participants

Adverse Events

Human Rotavirus (HRV) Group

Serious events: 251 serious events

Other events: 596 other events

Deaths: 1 deaths

HRV Porcine Circovirus (PCV)-Free Group

Serious events: 262 serious events

Other events: 617 other events

Deaths: 0 deaths

Serious adverse events

Measure	Human Rotavirus (HRV) Group n=998 participants at risk Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=1002 participants at risk Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Infections and infestations Pneumonia	14.0% 140/998 • Number of events 163 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	13.8% 138/1002 • Number of events 160 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bronchitis	3.9% 39/998 • Number of events 41 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	3.6% 36/1002 • Number of events 37 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Febrile infection	2.1% 21/998 • Number of events 23 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	2.0% 20/1002 • Number of events 22 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Upper respiratory tract infection	1.1% 11/998 • Number of events 12 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.1% 11/1002 • Number of events 12 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pharyngitis	0.50% 5/998 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.3% 13/1002 • Number of events 14 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastroenteritis	0.60% 6/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia bacterial	0.60% 6/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastrointestinal infection	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.80% 8/1002 • Number of events 8 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Laryngitis	0.70% 7/998 • Number of events 7 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Herpangina	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.50% 5/1002 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Laryngopharyngitis	0.60% 6/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Sepsis	0.50% 5/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastroenteritis rotavirus	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia haemophilus	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations COVID-19	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.50% 5/1002 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Influenza	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Respiratory tract infection	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Enterobacter pneumonia	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia escherichia	0.40% 4/998 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia staphylococcal	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia klebsiella	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Tracheobronchitis mycoplasmal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia mycoplasmal	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Diarrhoea infectious	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Tonsillitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Urinary tract infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia respiratory syncytial viral	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Tracheitis	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bacterial infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bronchiolitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Exanthema subitum	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastroenteritis adenovirus	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia parainfluenzae viral	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Tonsillitis bacterial	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Viral upper respiratory tract infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pertussis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pharyngitis bacterial	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Coxsackie viral infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Meningitis bacterial	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Mycoplasma infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pharyngitis mycoplasmal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia pneumococcal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia pseudomonal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Respiratory syncytial virus infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Anal abscess	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bacteraemia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bacterial diarrhoea	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bronchitis mycoplasmal	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Coronavirus pneumonia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Haemophilus infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Impetigo	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Nasopharyngitis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Otitis media	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Otitis media acute	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia moraxella	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia streptococcal	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Skin infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Varicella	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Enteritis	0.60% 6/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.50% 5/1002 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Infantile diarrhoea	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Diarrhoea	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Functional gastrointestinal disorder	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gastritis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Intussusception	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Mouth ulceration	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 7 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Cardiac failure	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Cardiac failure acute	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Angina pectoris	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Urticaria	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Rash	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Nervous system disorders Febrile convulsion	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Nervous system disorders Loss of consciousness	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Nervous system disorders Coordination abnormal	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Congenital megacolon	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Craniosynostosis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Vascular malformation	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Injury, poisoning and procedural complications Craniocerebral injury	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Injury, poisoning and procedural complications Skull fracture	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Dehydration	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Hypokalaemia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Hepatobiliary disorders Liver injury	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Vascular disorders Shock	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Immune system disorders Food allergy	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangioma	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.

Other adverse events

Measure	Human Rotavirus (HRV) Group n=998 participants at risk Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	HRV Porcine Circovirus (PCV)-Free Group n=1002 participants at risk Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
Infections and infestations Respiratory tract infection	18.1% 181/998 • Number of events 203 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	21.9% 219/1002 • Number of events 255 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Upper respiratory tract infection	4.6% 46/998 • Number of events 48 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	4.5% 45/1002 • Number of events 55 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bronchitis	1.3% 13/998 • Number of events 13 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.4% 14/1002 • Number of events 14 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pharyngitis	1.4% 14/998 • Number of events 15 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.90% 9/1002 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Nasopharyngitis	0.80% 8/998 • Number of events 8 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.90% 9/1002 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastroenteritis	0.80% 8/998 • Number of events 8 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.70% 7/1002 • Number of events 7 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Laryngitis	0.40% 4/998 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Pneumonia	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Candida infection	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Influenza	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Rhinitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Conjunctivitis	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Cytomegalovirus infection	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Oral candidiasis	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Rhinovirus infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Bronchiolitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Dacryocystitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Dermatitis infected	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Diarrhoea infectious	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Eczema infected	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Exanthema subitum	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Gastrointestinal infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Herpangina	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Mycoplasma infection	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Sinusitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Acute sinusitis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Adenovirus infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Chlamydial infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Conjunctivitis bacterial	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Enterobacter infection	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Infections and infestations Otitis media	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Diarrhoea	12.3% 123/998 • Number of events 133 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	11.8% 118/1002 • Number of events 131 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Vomiting	8.5% 85/998 • Number of events 98 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	9.5% 95/1002 • Number of events 106 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Constipation	1.3% 13/998 • Number of events 13 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.8% 18/1002 • Number of events 18 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Dyspepsia	0.90% 9/998 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.70% 7/1002 • Number of events 7 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Abdominal distension	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Infantile diarrhoea	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Functional gastrointestinal disorder	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Haematochezia	0.30% 3/998 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gastrointestinal disorder	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Enteritis	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Flatulence	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Abdominal pain	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Abdominal tenderness	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Dry mouth	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Gingival cyst	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Infantile colic	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Inguinal hernia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Mouth ulceration	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Regurgitation	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Dyschezia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Gastrointestinal disorders Mucous stools	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 91/998 • Number of events 96 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	8.7% 87/1002 • Number of events 94 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.1% 61/998 • Number of events 62 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	8.1% 81/1002 • Number of events 86 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	3.5% 35/998 • Number of events 39 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	2.5% 25/1002 • Number of events 26 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.90% 9/998 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.3% 13/1002 • Number of events 14 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Sneezing	0.90% 9/998 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.60% 6/1002 • Number of events 8 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Productive cough	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Sputum retention	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Hypoventilation neonatal	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
General disorders Pyrexia	17.8% 178/998 • Number of events 201 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	17.8% 178/1002 • Number of events 195 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
General disorders Peripheral swelling	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Psychiatric disorders Irritability	14.9% 149/998 • Number of events 179 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	15.5% 155/1002 • Number of events 191 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Psychiatric disorders Sleep terror	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Decreased appetite	9.1% 91/998 • Number of events 104 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	10.2% 102/1002 • Number of events 114 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Electrolyte imbalance	0.40% 4/998 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.80% 8/1002 • Number of events 8 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Hyperlactacidaemia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Hyperkalaemia	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Hypercalcaemia	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Acid-base balance disorder mixed	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Lactic acidosis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Dehydration	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Metabolism and nutrition disorders Vitamin K deficiency	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Eczema	1.7% 17/998 • Number of events 19 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	1.8% 18/1002 • Number of events 18 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Rash	0.60% 6/998 • Number of events 6 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.40% 4/1002 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Eczema infantile	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Pityriasis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Rash erythematous	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Myocardial necrosis marker increased	1.0% 10/998 • Number of events 11 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.90% 9/1002 • Number of events 9 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Immunoglobulins decreased	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Liver function test abnormal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Blood lactate dehydrogenase increased	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Bile acids increased	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Occult blood positive	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Investigations Transaminases increased	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Anaemia	0.50% 5/998 • Number of events 5 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Coagulopathy	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Neutropenia	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Granulocytopenia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Hypofibrinogenaemia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Leukopenia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Secondary thrombocytosis	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Myocardial injury	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.70% 7/1002 • Number of events 7 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Sinus arrhythmia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Sinus tachycardia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Cardiac disorders Myocarditis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Hepatobiliary disorders Liver injury	0.40% 4/998 • Number of events 4 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.30% 3/1002 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Hepatobiliary disorders Hepatic function abnormal	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Hepatobiliary disorders Hypercholia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Hepatobiliary disorders Cholestasis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Eye disorders Eye discharge	0.30% 3/998 • Number of events 3 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Eye disorders Dacryostenosis acquired	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Eye disorders Blepharitis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Eye disorders Keratitis	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Atrial septal defect	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Congenital laryngeal stridor	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Ventricular septal defect	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Congenital, familial and genetic disorders Congenital laryngeal malformation	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Immune system disorders Transient hypogammaglobulinaemia of infancy	0.20% 2/998 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.20% 2/1002 • Number of events 2 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Immune system disorders Hypersensitivity	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Nervous system disorders Drooling	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Nervous system disorders Somnolence	0.00% 0/998 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.10% 1/1002 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Endocrine disorders Transient neonatal hyperthyrotropinaemia	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.10% 1/998 • Number of events 1 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.	0.00% 0/1002 • Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7. SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.

Additional Information

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GlaxoSmithKline

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• 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.
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Restriction type: OTHER