Trial Outcomes & Findings for Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants (NCT NCT00806195)

NCT ID: NCT00806195

Last Updated: 2013-07-09

Results Overview

To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7744 participants
• Primary outcome timeframe: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
• Results posted on: 2013-07-09

Participant Flow

All subjects enrolled were included in the trial.

Participant milestones

Measure	MenACWY-CRM197 + Routine Vaccines (Non-detailed) Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE).	Routine Vaccines (Non-detailed) Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.	MenACWY-CRM197 + Routine Vaccines (Detailed) Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	Routine Vaccines (Detailed) Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs.
Overall Study STARTED	4363	1483	1409	489
Overall Study COMPLETED	3849	1321	1139	383
Overall Study NOT COMPLETED	514	162	270	106

Reasons for withdrawal

Measure	MenACWY-CRM197 + Routine Vaccines (Non-detailed) Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE).	Routine Vaccines (Non-detailed) Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.	MenACWY-CRM197 + Routine Vaccines (Detailed) Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	Routine Vaccines (Detailed) Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs.
Overall Study Death	6	0	1	0
Overall Study Adverse Event	25	5	11	2
Overall Study Withdrawal by Subject	119	31	76	35
Overall Study Lost to Follow-up	217	66	90	34
Overall Study Inappropriate Enrollment	0	1	0	0
Overall Study Administrative Reason	113	35	66	26
Overall Study Protocol Violation	34	24	26	9

Baseline Characteristics

Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Baseline characteristics by cohort

Measure	MenACWY-CRM197 + Routine Vaccines (Non-Detailed) n=4363 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.	Routine Vaccines (Non-Detailed) n=1483 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.	MenACWY-CRM197 + Routine Vaccines (Detailed) n=1409 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	Routine Vaccines (Detailed) n=489 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	Total n=7744 Participants Total of all reporting groups
Age Continuous	64.9 Days STANDARD_DEVIATION 7.4 • n=93 Participants	64.7 Days STANDARD_DEVIATION 7.1 • n=4 Participants	65.5 Days STANDARD_DEVIATION 6.5 • n=27 Participants	65.2 Days STANDARD_DEVIATION 6.3 • n=483 Participants	65.0 Days STANDARD_DEVIATION 7.1 • n=36 Participants
Sex: Female, Male Female	2135 Participants n=93 Participants	703 Participants n=4 Participants	716 Participants n=27 Participants	232 Participants n=483 Participants	3786 Participants n=36 Participants
Sex: Female, Male Male	2228 Participants n=93 Participants	780 Participants n=4 Participants	693 Participants n=27 Participants	257 Participants n=483 Participants	3958 Participants n=36 Participants

PRIMARY outcome

Timeframe: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age

Population: Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).

To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.

Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

Outcome measures

Measure	MenACWY-CRM197 + Routine Vaccines (Detailed) n=1349 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.	Routine Vaccines (Detailed) n=461 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination	16 Percentages of subjects	13 Percentages of subjects

SECONDARY outcome

Timeframe: Day 1 (2 months of age) to 18 months of age

Population: Analysis was done on as treated safety population.

To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.

Outcome measures

Measure	MenACWY-CRM197 + Routine Vaccines (Detailed) n=5760 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.	Routine Vaccines (Detailed) n=1968 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period	6 Percentages of subjects	6 Percentages of subjects

SECONDARY outcome

Timeframe: 15 minutes to Day 7

Population: Analysis was done on as treated safety population.

To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.

Outcome measures

Measure	MenACWY-CRM197 + Routine Vaccines (Detailed) n=1313 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.	Routine Vaccines (Detailed) n=451 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Vomiting (N=1094, 353)	5 percentages of subjects	4 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Local (2 month vaccination) (N=1313, 451)	53 percentages of subjects	56 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Tenderness (N=1301, 446)	46 percentages of subjects	49 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Erythema (N=1297, 445)	17 percentages of subjects	21 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Induration (N=1297, 446)	8 percentages of subjects	16 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Local (4 month vaccination) (N=1262, 420)	46 percentages of subjects	54 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Tenderness (N=1255, 418)	37 percentages of subjects	42 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Erythema (N=1257, 417)	19 percentages of subjects	29 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Induration (N=1257, 417)	9 percentages of subjects	17 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Local (6 month vaccination) (N=1120, 374)	41 percentages of subjects	50 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Tenderness (N=1106, 372)	30 percentages of subjects	37 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Erythema (N=1104, 370)	22 percentages of subjects	29 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Induration (N=1107, 370)	9 percentages of subjects	19 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Local (12 month vaccination) (N=1102, 355)	47 percentages of subjects	57 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Tenderness (N=1098, 353)	39 percentages of subjects	50 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Erythema (N=1095, 349)	21 percentages of subjects	30 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Injection Site Induration (N=1095, 351)	10 percentages of subjects	23 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Systemic (2 month vaccination) (N=1313, 451)	77 percentages of subjects	73 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Rash (N=1296, 446)	3 percentages of subjects	3 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Change in Eating Habits (N=1289, 446)	23 percentages of subjects	24 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Sleepiness (N=1297, 447)	52 percentages of subjects	52 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Persistent crying (N=1299,46)	42 percentages of subjects	40 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Irritability (N=1300, 446)	59 percentages of subjects	59 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Vomiting (N=1298, 446)	10 percentages of subjects	9 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Diarrhea (N=1299, 446)	16 percentages of subjects	11 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Fever ( ≥ 38°C) (N=1297, 446)	3 percentages of subjects	2 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Analges.Antipyr.Meds (N=1302, 448)	66 percentages of subjects	60 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Systemic (4 month vaccination) (N=1262, 420)	65 percentages of subjects	63 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Rash (N=1253, 416)	3 percentages of subjects	4 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Change in Eating Habits (N=1245, 414)	18 percentages of subjects	17 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Sleepiness (N=1253, 416)	38 percentages of subjects	37 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Persistent Crying (N=1254, 417)	31 percentages of subjects	28 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Irritability (N=1254, 416)	50 percentages of subjects	48 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Vomiting (N=1254, 416)	8 percentages of subjects	6 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Diarrhea (N=1255, 416)	11 percentages of subjects	8 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Fever ( ≥ 38°C) (N=1251, 416)	4 percentages of subjects	6 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Analges.Antipyr.Meds (N=1254, 416)	58 percentages of subjects	55 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Systemic (6 month vaccination) (N=1120, 374)	58 percentages of subjects	54 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Rash (N=1101, 367)	3 percentages of subjects	3 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Change in Eating Habits (N=1094, 367)	17 percentages of subjects	14 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Sleepiness (N=1104, 367)	31 percentages of subjects	29 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Persistent Crying (N=1103, 368)	26 percentages of subjects	20 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Irritability (N=1104, 369)	46 percentages of subjects	41 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Vomiting (N=1106, 369)	6 percentages of subjects	4 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Diarrhea (N=1102, 369)	8 percentages of subjects	6 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Fever ( ≥ 38°C) (N=1108, 368)	7 percentages of subjects	6 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Analges.Antipyr.Meds (N=1103, 370)	53 percentages of subjects	49 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Any Systemic (12 month vaccination) (N=1102, 355)	63 percentages of subjects	62 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Rash (N=1093, 353)	4 percentages of subjects	5 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Change in Eating Habits (N=1089, 348)	18 percentages of subjects	16 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Sleepiness (N=1096, 353)	30 percentages of subjects	29 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Persistent Crying (N=1094, 353)	28 percentages of subjects	24 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Irritability (N=1094, 354)	50 percentages of subjects	49 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Diarrhea (N=1094, 353)	12 percentages of subjects	9 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Fever ( ≥ 38°C) (N=1092, 353)	9 percentages of subjects	8 percentages of subjects
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Analges.Antipyr.Meds (N=1095, 354)	49 percentages of subjects	50 percentages of subjects

SECONDARY outcome

Timeframe: Day 1 (2 months of age) to 18 months of age

Population: Analysis was done on as treated safety population.

Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.

Outcome measures

Measure	MenACWY-CRM197 + Routine Vaccines (Detailed) n=5760 Participants Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.	Routine Vaccines (Detailed) n=1968 Participants Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination Any AE	4848 Subjects	1659 Subjects
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination Any SAE-Total	354 Subjects	114 Subjects
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination Possibly or Probably Related AEs	520 Subjects	2 Subjects
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination AEs Leading to Premature Withdrawals	44 Subjects	8 Subjects
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination Deaths	7 Subjects	1 Subjects

Adverse Events

MenACWY-CRM197 + Routine Vaccines (All)

Serious events: 354 serious events

Other events: 4701 other events

Deaths: 0 deaths

Routine Vaccines (All)

Serious events: 114 serious events

Other events: 1600 other events

Deaths: 0 deaths

Serious adverse events

Measure	MenACWY-CRM197 + Routine Vaccines (All) n=5760 participants at risk Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.	Routine Vaccines (All) n=1968 participants at risk Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.
Injury, poisoning and procedural complications Fall	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Foreign Body	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Anaemia	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Leukocytosis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Mesenteric Lymphadenopathy	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Thrombocytopenia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Cardiac disorders Cardiac Arrest	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Cardiac disorders Cyanosis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Cardiac disorders Supraventricular Tachycardia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Cardiac disorders Ventricular Tachycardia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Anomalous Pulmonary Venous Connection	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Congenital Absence Of Bile Ducts	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Congenital Aplastic Anaemia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Craniosynostosis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Cryptorchism	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Hamartoma	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Mitochondrial Enzyme Deficiency	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Osteognesis Imperfecta	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Patent Ductus Arteriosus	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Phimosis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Pyloric Stenosis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Congenital, familial and genetic disorders Vitello-Intestinal Duct Remnant	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Abdominal Pain	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Constipation	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Diarrhoea	0.09% 5/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Enteritis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Enterocolitis	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Gastritis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Ileus	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Inguinal Hernia	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Inguinal Hernia, Obstructive	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Intussusception	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Stomatitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Vomiting	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Brain Death	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Hernia	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Pyrexia	0.12% 7/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Hepatobiliary disorders Jaundice	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Acute Tonsilitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Adenovirus Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Arthritis Bacterial	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Ascariasis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bacteraemia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bacterial Diarrhoea	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bacterial Tracheitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bronchiolitis	1.1% 64/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.76% 15/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bronchitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bronchopneumonia	0.33% 19/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.25% 5/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Cellulitis	0.09% 5/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.20% 4/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Cellulitis Staphylococcal	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Cellulitis Streptococcal	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Chest Wall Abscess	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Croup Infectious	0.17% 10/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.25% 5/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Diarrhoea Infectious	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Dysentery	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Enterovirus Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Escherichia Urinary Tract Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Exanthema Subitam	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Furuncle	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Gastroenteritis	0.35% 20/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.36% 7/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Gastroenteritis Rotavirus	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Gastroenteritis Salmonella	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Gastroenteritis Viral	0.12% 7/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Genital Abscess	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Groin Abscess	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Haemophilus Bacteraemia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Hand-Foot-And-Mouth Disease	0.17% 10/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Herpangina	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Incision Site Cellulitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Infected Cyst	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Influenza	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Klebsiella Bacteraemia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Lobar Pneumonia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Lower Respiratory Tract Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Lymph Node Abscess	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Meningitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Meningitis Enteroviral	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Metapneumovirus Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Otitis Media	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Otitis Media Acute	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Periorbital Cellulitis	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Peritonsillar Abscess	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pharyngitis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia	0.54% 31/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.51% 10/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pharyngotonsillitis	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumococcal bacteraemia	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Adenoviral	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Bacterial	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Influenzal	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Primary Atypical	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Respiratory Syncytial Viral	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pneumonia Viral	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pyelonephritis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pyelonephritis Acute	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	0.35% 20/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.36% 7/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Respiratory Synctial Virus Infection	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Rotavirus Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Sepsis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Septic Shock	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Sinusitis	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Staphylococcal Abscess	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Tonsilitis	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Upper Respiratory Tract Infection	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Urachal Abscess	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Urinary Tract Infection	0.49% 28/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.51% 10/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Urinary Tract Infection Enterococcal	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Urosepsis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Varicella	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Viral Diarrhoea	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Viral Infection	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Wound Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Accidental Poisoning	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Contusion	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Craniocerebral Injury	0.09% 5/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Electrical Burn	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Head Injury	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Humerus Fracture	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Injury	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Skull Fracture	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Subdural Haemorrhage	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Thermal Burn	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Tibia Fracture	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Upper Limb Fracture	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Investigations Electrocardiogram Qt Prolonged	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Metabolism and nutrition disorders Dehydration	0.31% 18/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.46% 9/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Metabolism and nutrition disorders Failure To Thrive	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Metabolism and nutrition disorders Feeding Disorder	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Metabolism and nutrition disorders Hypoglycaemia	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Metabolism and nutrition disorders Metabolic Acidosis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Acute Disseminated Encephalomyelitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Convulsion	0.09% 5/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Encephalitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Epilepsy	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Febrile Convulsion	0.16% 9/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.30% 6/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Hydrocephalus	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Myoclonic Epilepsy	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Presyncope	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Syncope	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Tremor	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Psychiatric disorders Breath Holding	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Psychiatric disorders Drug Abuse	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Psychiatric disorders Mental Status Changes	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Renal and urinary disorders Renal Failure Acute	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Renal and urinary disorders Renal Mass	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Renal and urinary disorders Vesicoureteric Reflux	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Reproductive system and breast disorders Balanitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Reproductive system and breast disorders Scrotal mass	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Adenoidal Hypertrophy	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Asthma	0.10% 6/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.10% 2/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.10% 6/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.30% 6/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Bronchomalacia	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 3/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.21% 12/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Status Asthmaticus	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.15% 3/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Wheezing	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Dermal Cyst	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Surgical and medical procedures Hernia Repair	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Surgical and medical procedures Inguinal Hernia Repair	0.00% 0/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Vascular disorders Angiopathy	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Vascular disorders Kawasaki's Disease	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.05% 1/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Vascular disorders Vasculitis	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Eye disorders Retinal Haemorrhage	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Lymphadenitis	0.07% 4/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Blood and lymphatic system disorders Lymphadenopathy	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Meningitis Viral	0.03% 2/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Injury, poisoning and procedural complications Subdural Hematoma	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Staphylococcal Infection	0.02% 1/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	0.00% 0/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.

Other adverse events

Measure	MenACWY-CRM197 + Routine Vaccines (All) n=5760 participants at risk Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.	Routine Vaccines (All) n=1968 participants at risk Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.
Blood and lymphatic system disorders Anaemia	4.8% 276/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	4.8% 94/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Eye disorders Conjunctivitis	12.7% 732/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	11.9% 234/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Constipation	4.8% 275/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	5.0% 98/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Diarrhoea	20.5% 1181/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	18.1% 356/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Teething	5.1% 294/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	5.4% 106/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Gastrointestinal disorders Vomiting	8.7% 500/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	7.9% 155/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Injection Site Erythema	9.0% 519/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	12.2% 241/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Injection Site Induration	4.9% 284/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	9.2% 181/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Injection Site Pain	15.9% 916/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	17.2% 338/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Irritability	19.9% 1146/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	20.6% 405/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
General disorders Pyrexia	21.5% 1239/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	19.0% 373/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bronchiolitis	14.3% 826/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	15.2% 299/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Bronchitis	7.7% 446/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	7.8% 153/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Croup Infectious	4.9% 284/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	5.0% 98/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Gastroenteritis	9.1% 524/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	9.1% 179/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Influenza	7.2% 415/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	6.3% 124/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Nasopharyngitits	13.0% 751/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	12.1% 239/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Otitis Media	27.4% 1579/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	28.0% 551/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Otitis Media Acute	7.2% 412/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	7.8% 154/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Pharyngitits	10.6% 609/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	10.6% 208/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Sinusitis	5.1% 296/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	4.7% 93/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Upper Respiratory Tract Infection	40.9% 2358/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	42.8% 842/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Infections and infestations Viral Infection	10.3% 591/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	8.9% 175/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Crying	14.9% 859/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	14.1% 277/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Nervous system disorders Somnolence	16.1% 927/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	15.6% 307/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Psychiatric disorders Eating Disorder	10.3% 593/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	9.5% 187/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Respiratory, thoracic and mediastinal disorders Cough	8.8% 504/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	8.7% 171/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Dermatitis Diaper	10.9% 628/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	10.2% 201/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Eczema	6.9% 399/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	7.4% 145/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
Skin and subcutaneous tissue disorders Rash	5.3% 307/5760 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.	5.5% 109/1968 • Throughout study period. Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60