Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks (NCT NCT02914184)

NCT ID: NCT02914184

Last Updated: 2020-07-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1612 participants

Primary outcome timeframe

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

Results posted on

2020-07-21

Participant Flow

The study was conducted at 66 centers in 8 countries: 2 in Costa Rica, 10 in Finland, 6 in Germany, 7 in Japan, 6 in Republic of Korea, 9 in Spain, 6 in Taiwan and 20 in the United States (US).

Among 1612 subjects enrolled in the study, 1600 were vaccinated and 1545 completed the study.

Participant milestones

Participant milestones
Measure	Liq_A Group Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Overall Study STARTED	400	396	402	402
Overall Study COMPLETED	386	383	385	391
Overall Study NOT COMPLETED	14	13	17	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Liq_A Group Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Overall Study Lost to Follow-up	7	10	8	7
Overall Study Withdrawal by Subject	4	2	7	3
Overall Study Other	1	0	0	0
Overall Study Migrated/moved from the study area	2	1	2	1

Baseline Characteristics

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liq_A Group n=400 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.	Total n=1600 Participants Total of all reporting groups
Age, Continuous	8.5 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants	8.3 Weeks STANDARD_DEVIATION 1.5 • n=7 Participants	8.4 Weeks STANDARD_DEVIATION 1.6 • n=5 Participants	8.5 Weeks STANDARD_DEVIATION 1.5 • n=4 Participants	8.4 Weeks STANDARD_DEVIATION 1.5 • n=21 Participants
Sex: Female, Male Female	208 Participants n=5 Participants	198 Participants n=7 Participants	205 Participants n=5 Participants	203 Participants n=4 Participants	814 Participants n=21 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	198 Participants n=7 Participants	197 Participants n=5 Participants	199 Participants n=4 Participants	786 Participants n=21 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized Asian	95 Participants n=5 Participants	96 Participants n=7 Participants	98 Participants n=5 Participants	95 Participants n=4 Participants	384 Participants n=21 Participants
Race/Ethnicity, Customized Black Or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	29 Participants n=5 Participants	31 Participants n=7 Participants	26 Participants n=5 Participants	27 Participants n=4 Participants	113 Participants n=21 Participants
Race/Ethnicity, Customized White	263 Participants n=5 Participants	258 Participants n=7 Participants	262 Participants n=5 Participants	262 Participants n=4 Participants	1045 Participants n=21 Participants

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=332 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)	155.7 U/mL Interval 125.6 to 193.1	147.3 U/mL Interval 118.4 to 183.3	175.9 U/mL Interval 142.8 to 216.8	—

PRIMARY outcome

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

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

Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.

Outcome measures

Outcome measures
Measure	Liq_A Group n=984 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=329 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group	79.3 Percentage of subjects Interval 76.6 to 81.8	81.8 Percentage of subjects Interval 77.2 to 85.8	—	—

PRIMARY outcome

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

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

Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.

Outcome measures

Outcome measures
Measure	Liq_A Group n=332 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=329 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group	77.7 Percentage of subjects Interval 72.8 to 82.1	77.6 Percentage of subjects Interval 72.7 to 82.0	82.5 Percentage of subjects Interval 77.9 to 86.5	81.8 Percentage of subjects Interval 77.2 to 85.8

PRIMARY outcome

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

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

Antibody concentrations against RV were determined as GMCs and expressed as U/mL. For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of antibody concentrations at 1-2 months after Dose 2.

Outcome measures

Outcome measures
Measure	Liq_A Group n=984 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=329 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group	159.2 U/mL Interval 140.7 to 180.1	153.8 U/mL Interval 125.1 to 189.0	—	—

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=332 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=329 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group	155.7 U/mL Interval 125.6 to 193.1	147.3 U/mL Interval 118.4 to 183.3	175.9 U/mL Interval 142.8 to 216.8	153.8 U/mL Interval 125.1 to 189.0

SECONDARY outcome

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

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

Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL, 1-2 months after Dose 2

Outcome measures

Outcome measures
Measure	Liq_A Group n=984 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=329 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)	63.0 Percentage of subjects Interval 59.9 to 66.0	62.3 Percentage of subjects Interval 56.8 to 67.6	—	—

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=322 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=326 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=329 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups)	62.7 Percentage of subjects Interval 57.2 to 67.9	61.0 Percentage of subjects Interval 55.5 to 66.4	65.3 Percentage of subjects Interval 59.9 to 70.5	62.3 Percentage of subjects Interval 56.8 to 67.6

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=400 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Cough / Runny Nose - Dose 2	114 Participants	100 Participants	94 Participants	109 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Fever (≥ 38.0°C) - Dose 2	36 Participants	36 Participants	34 Participants	32 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Loss of appetite - Dose 1	97 Participants	93 Participants	99 Participants	96 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Cough / Runny Nose - Dose 1	93 Participants	91 Participants	94 Participants	102 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Diarrhea - Dose 1	14 Participants	13 Participants	8 Participants	10 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Diarrhea - Dose 2	7 Participants	12 Participants	8 Participants	11 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Fever (≥ 38.0°C) - Dose 1	24 Participants	22 Participants	20 Participants	23 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Irritability / Fussiness - Dose 1	226 Participants	214 Participants	209 Participants	216 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Irritability / Fussiness - Dose 2	191 Participants	189 Participants	194 Participants	194 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Loss of appetite - Dose 2	92 Participants	84 Participants	78 Participants	94 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Vomiting - Dose 1	39 Participants	51 Participants	38 Participants	42 Participants
Number of Subjects With Any Solicited General Adverse Events (AEs). Any - Vomiting - Dose 2	25 Participants	28 Participants	31 Participants	34 Participants

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=400 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Number of Subjects With Any Unsolicited AEs.	183 Participants	189 Participants	200 Participants	184 Participants

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Liq_A Group n=400 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 Participants Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 Participants Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Number of Subjects With Any Serious Adverse Events (SAEs)	21 Participants	18 Participants	21 Participants	18 Participants

Adverse Events

Liq_A Group

Serious events: 21 serious events

Other events: 333 other events

Deaths: 0 deaths

Liq_B Group

Serious events: 18 serious events

Other events: 242 other events

Deaths: 0 deaths

Liq_C Group

Serious events: 21 serious events

Other events: 338 other events

Deaths: 0 deaths

Lyo Control Group

Serious events: 18 serious events

Other events: 338 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Liq_A Group n=400 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 participants at risk Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Infections and infestations Encephalitis enteroviral	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory syncytial virus bronchitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Abscess jaw	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Acute sinusitis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Allergic gastroenteritis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Bronchiolitis	1.0% 4/400 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Bronchitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Concussion	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Conjunctivitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Dehydration	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Gastroenteritis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Gastroenteritis viral	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Infantile colic	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Infantile spasms	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Influenza	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Intussusception	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Meningitis haemophilus	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Metapneumovirus infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Immune system disorders Milk allergy	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Myelitis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroblastoma	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Otitis media	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Otitis media acute	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Otitis media chronic	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pharyngitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pneumococcal sepsis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pneumonia	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pneumonia pneumococcal	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pyelonephritis acute	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Pyrexia	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory syncytial virus bronchiolitis	1.5% 6/400 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory syncytial virus infection	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Seizure	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Staphylococcal abscess	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Subdural hygroma	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Urinary tract infection	0.25% 1/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Viral infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Vomiting	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Vulval abscess	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).

Other adverse events

Other adverse events
Measure	Liq_A Group n=400 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot A at 6 and 12 weeks of age.	Liq_B Group n=396 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot B at 6 and 12 weeks of age.	Liq_C Group n=402 participants at risk Subjects who received two doses of PCV-free HRV liquid formulation of lot C at 6 and 12 weeks of age.	Lyo Control Group n=402 participants at risk Subjects who received two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age.
Infections and infestations Skin bacterial infection	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Streptococcal infection	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Cardiac disorders Arrhythmia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Brachycephaly	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Craniosynostosis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Gray matter heterotopia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Hydrocele	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Plagiocephaly	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Ear and labyrinth disorders Cerumen impaction	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Blepharitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Conjunctival haemorrhage	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Dacryostenosis acquired	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Eye allergy	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Eye discharge	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Lacrimation increased	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Eye disorders Ocular hyperaemia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Abdominal pain	1.5% 6/400 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.2% 5/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.7% 7/402 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Abdominal pain upper	0.75% 3/400 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Abnormal faeces	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Aerophagia	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Anal fissure	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Constipation	1.5% 6/400 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.5% 10/396 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Diarrhoea	9.5% 38/400 • Number of events 57 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	6.3% 25/396 • Number of events 25 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	7.7% 31/402 • Number of events 45 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	10.9% 44/402 • Number of events 59 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Enteritis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Epigastric discomfort	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Eructation	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Flatulence	1.2% 5/400 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Gastrooesophageal reflux disease	2.5% 10/400 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.3% 9/396 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.7% 11/402 • Number of events 11 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Haematochezia	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Infantile colic	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Mucous stools	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Perianal erythema	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Post-tussive vomiting	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Regurgitation	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Teething	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.0% 4/396 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Gastrointestinal disorders Vomiting	1.8% 7/400 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Crying	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Discomfort	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Fatigue	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Injection site induration	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Injection site mass	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Injection site pain	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Injection site swelling	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Pain	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Pyrexia	2.5% 10/400 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/396 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	3.2% 13/402 • Number of events 13 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Vaccination site discomfort	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
General disorders Vaccination site pain	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Immune system disorders Anaphylactic reaction	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Immune system disorders Hypersensitivity	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Immune system disorders Immunisation reaction	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Immune system disorders Milk allergy	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Acarodermatitis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Acute sinusitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Anal abscess	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Anal candidiasis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Bronchiolitis	2.5% 10/400 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.5% 10/396 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.7% 7/402 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.2% 9/402 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Bronchitis	1.2% 5/400 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.0% 4/396 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Bronchitis bacterial	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Candida infection	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Conjunctivitis	1.8% 7/400 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.3% 5/396 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.7% 11/402 • Number of events 11 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.7% 11/402 • Number of events 12 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Conjunctivitis bacterial	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Conjunctivitis viral	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Croup infectious	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Ear infection	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Fungal infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Fungal skin infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Gastroenteritis	2.2% 9/400 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Hand-foot-and-mouth disease	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Herpangina	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Impetigo	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Influenza	1.0% 4/400 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.0% 4/396 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Laryngitis	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Lower respiratory tract infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Nasopharyngitis	6.0% 24/400 • Number of events 25 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	6.3% 25/396 • Number of events 25 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	9.0% 36/402 • Number of events 40 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	7.2% 29/402 • Number of events 37 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Oral candidiasis	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Oral fungal infection	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Oral herpes	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Otitis media	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.3% 5/396 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Otitis media acute	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.2% 5/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Paronychia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pharyngitis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Pneumonia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory tract infection	0.50% 2/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/396 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Respiratory tract infection viral	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Rhinitis	0.75% 3/400 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.8% 7/396 • Number of events 7 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Subglottic laryngitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Tonsillitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Tracheobronchitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Upper respiratory tract infection	7.8% 31/400 • Number of events 33 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	8.6% 34/396 • Number of events 34 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	7.7% 31/402 • Number of events 36 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	7.5% 30/402 • Number of events 32 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Urinary tract infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Viral infection	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Viral rash	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Viral upper respiratory tract infection	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Infections and infestations Vulvovaginal candidiasis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Contusion	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Fall	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Head injury	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Sunburn	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Injury, poisoning and procedural complications Vaccination complication	1.0% 4/400 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Investigations Body temperature increased	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Abnormal weight gain	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Appetite disorder	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Decreased appetite	36.2% 145/400 • Number of events 192 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	34.6% 139/402 • Number of events 177 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	35.1% 141/402 • Number of events 191 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Feeding disorder	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Malnutrition	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Poor feeding infant	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Underweight	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Metabolism and nutrition disorders Weight gain poor	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Musculoskeletal and connective tissue disorders Acquired plagiocephaly	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Musculoskeletal and connective tissue disorders Head deformity	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Musculoskeletal and connective tissue disorders Torticollis	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Depressed level of consciousness	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Drooling	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Febrile convulsion	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Seizure	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Nervous system disorders Somnolence	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Psychiatric disorders Agitation	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Psychiatric disorders Insomnia	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Psychiatric disorders Irritability	69.0% 276/400 • Number of events 426 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.3% 5/396 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	65.7% 264/402 • Number of events 408 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	64.9% 261/402 • Number of events 419 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Psychiatric disorders Merycism	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Psychiatric disorders Selective eating disorder	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Renal and urinary disorders Crystalluria	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Reproductive system and breast disorders Balanoposthitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Reproductive system and breast disorders Penile adhesion	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Asthma	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Cough	41.2% 165/400 • Number of events 213 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	37.8% 152/402 • Number of events 198 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	40.5% 163/402 • Number of events 214 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.2% 5/402 • Number of events 5 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.25% 1/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Respiratory, thoracic and mediastinal disorders Wheezing	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Acne infantile	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Asteatosis	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Blister	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Dermatitis	1.5% 6/400 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.75% 3/402 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.50% 2/400 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.2% 9/402 • Number of events 9 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Dermatitis diaper	1.0% 4/400 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/396 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.5% 6/402 • Number of events 6 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Eczema	2.2% 9/400 • Number of events 10 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	2.0% 8/402 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.7% 7/402 • Number of events 8 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Eczema infantile	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Mechanical urticaria	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Rash	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.51% 2/396 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	1.00% 4/402 • Number of events 4 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/396 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.50% 2/402 • Number of events 2 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.75% 3/400 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.76% 3/396 • Number of events 3 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/400 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).
Skin and subcutaneous tissue disorders Urticaria	0.25% 1/400 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/396 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.00% 0/402 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).	0.25% 1/402 • Number of events 1 • Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).

Additional Information

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Results disclosure agreements

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