Trial Outcomes & Findings for Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations (NCT NCT02446691)

Last Updated: 2019-06-27

Results Overview

Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None \[\<10mm\], Any\[\>=10 mm\]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever\[ body temperature \>=38°C measured preferably via tympanic route\]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

128 participants

Primary outcome timeframe

Within 30 minutes of each vaccination

Results posted on

2019-06-27

Participant Flow

Subjects were enrolled from 6 centers in South Korea.

All enrolled subjects were vaccinated.

Participant milestones

Participant milestones
Measure	MenACWY Group Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Overall Study STARTED	128
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY Group Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	8
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Age, Continuous	71.7 Days STANDARD_DEVIATION 8.09 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Race/Ethnicity, Customized Asian	127 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of each vaccination

Population: Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.

Outcome measures

Outcome measures
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Sleepiness, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 2, Yes	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 2, No	128 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 3, Yes	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 3, No	128 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 4, Yes	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 4, No	124 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site erythema, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site erythema, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site erythema, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site erythema, Vaccination 4, Any	1 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site induration, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site induration, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site induration, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site induration, Vaccination 4, Any	1 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site tenderness, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site tenderness, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site tenderness, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Injection site tenderness, Vaccination 4, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Change in eating habits, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Change in eating habits, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Change in eating habits, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Change in eating habits, Vaccination 4, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Diarrhea, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Diarrhea, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Diarrhea, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Diarrhea, Vaccination 4, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Irritability, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Irritability, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Irritability, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Irritability, Vaccination 4, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Sleepiness, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Sleepiness, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Sleepiness, Vaccination 4, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Vomiting, Vaccination 1, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Vomiting, Vaccination 2, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Vomiting, Vaccination 3, Any	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Vomiting, Vaccination 4, Any	1 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 1, Yes	0 Participants
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. Fever, Vaccination 1, No	128 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7 after each vaccination

Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (\<10 mm), Any (\>=10 mm)

Outcome measures

Outcome measures
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site erythema, Vaccination 1, Any	4 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site erythema, Vaccination 2, Any	6 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site erythema, Vaccination 4, Any	6 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site induration, Vaccination 1, Any	4 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site erythema, Vaccination 3, Any	6 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site induration, Vaccination 2, Any	9 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site induration, Vaccination 3, Any	3 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site induration, Vaccination 4, Any	6 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site tenderness, Vaccination 1, Any	17 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site tenderness, Vaccination 2, Any	21 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site tenderness, Vaccination 3, Any	14 Participants
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination Injection site tenderness, Vaccination 4, Any	20 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7 after each vaccination

Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).

Outcome measures

Outcome measures
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Change in eating habits, Vaccination 1, Any	29 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Change in eating habits, Vaccination 2, Any	21 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Change in eating habits, Vaccination 3, Any	21 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Change in eating habits, Vaccination 4, Any	24 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Diarrhea, Vaccination 1, Any	15 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Diarrhea, Vaccination 2, Any	13 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Diarrhea, Vaccination 3, Any	15 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Diarrhea, Vaccination 4, Any	17 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Irritability, Vaccination 1, Any	58 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Irritability, Vaccination 2, Any	49 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Irritability, Vaccination 3, Any	47 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Irritability, Vaccination 4, Any	45 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Sleepiness, Vaccination 1, Any	52 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Sleepiness, Vaccination 2, Any	31 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Sleepiness, Vaccination 3, Any	28 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Sleepiness, Vaccination 4, Any	20 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Vomiting, Vaccination 1, Any	26 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Vomiting, Vaccination 2, Any	20 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Vomiting, Vaccination 3, Any	15 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Vomiting, Vaccination 4, Any	5 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 1, Yes	4 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 1, No	124 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 2, Yes	10 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 2, No	118 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 3, Yes	6 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 3, No	121 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 4, Yes	15 Participants
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. Fever, Vaccination 4, No	109 Participants

PRIMARY outcome

Timeframe: From Day 1 to Visit 6 (at 24 Months of age)

Population: Analysis was performed on the unsolicited safety set, which included all subjects who received a study vaccination and reported any unsolicited adverse event data.

An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)\] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.

Outcome measures

Outcome measures
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal Any Medically Attended Unsolicited AEs	85 Participants
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal AEs leading to premature withdrawal	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Visit 6 (At 24 months of age)

Population: Analysis was performed on the overall safety set, which included all subjects who received a study vaccination and reported any solicited/unsolicited adverse event data.

Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

Outcome measures

Outcome measures
Measure	MenACWY Group n=128 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Number of Subjects With Serious AEs (SAEs)	26 Participants

PRIMARY outcome

Timeframe: At 24 months of age (Visit 6)

Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received at least one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.

To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.

Outcome measures

Outcome measures
Measure	MenACWY Group n=114 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. Serogroup A	39 Percentage of subjects Interval 30.4 to 49.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. Serogroup C	61 Percentage of subjects Interval 51.1 to 70.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. Serogroup W	88 Percentage of subjects Interval 80.1 to 93.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. Serogroup Y	89 Percentage of subjects Interval 81.3 to 93.8

PRIMARY outcome

Timeframe: At 24 months of age (Visit 6)

Population: Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.

To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement

Outcome measures

Outcome measures
Measure	MenACWY Group n=108 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup A	99 Percentage of subjects Interval 94.9 to 99.98
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup C	54 Percentage of subjects Interval 43.8 to 63.3
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup W	69 Percentage of subjects Interval 59.8 to 77.9
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup Y	90 Percentage of subjects Interval 82.3 to 94.8

PRIMARY outcome

Timeframe: At 24 months of age (Visit 6)

Outcome measures

Outcome measures
Measure	MenACWY Group n=108 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup A	98 Percentage of subjects Interval 93.5 to 99.77
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup C	30 Percentage of subjects Interval 21.2 to 39.2
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup W	62 Percentage of subjects Interval 52.2 to 71.2
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age Serogroup Y	80 Percentage of subjects Interval 71.6 to 87.4

SECONDARY outcome

Timeframe: At 13 months of age (Visit 5)

Population: The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received at least one study vaccination and who provided evaluable hSBA immunogenicity data at 1 month after last vaccination for at least one serogroup.

To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.

Outcome measures

Outcome measures
Measure	MenACWY Group n=122 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup A	94 Percentage of subjects Interval 88.5 to 97.7
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup C	98 Percentage of subjects Interval 94.2 to 99.8
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup W	100 Percentage of subjects Interval 97.0 to 100.0
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup Y	100 Percentage of subjects Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: At 13 months of age (Visit 5)

Population: The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.

Outcome measures

Outcome measures
Measure	MenACWY Group n=116 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup A	100 Percentage of subjects Interval 96.8 to 100.0
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup C	99 Percentage of subjects Interval 95.3 to 99.98
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup W	100 Percentage of subjects Interval 96.8 to 100.0
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup Y	100 Percentage of subjects Interval 96.9 to 100.0

SECONDARY outcome

Timeframe: At 13 months of age (Visit 5)

Outcome measures

Outcome measures
Measure	MenACWY Group n=116 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup A	100 Percentage of subjects Interval 96.8 to 100.0
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup C	92 Percentage of subjects Interval 85.7 to 96.4
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup W	98 Percentage of subjects Interval 93.9 to 99.79
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup Y	98 Percentage of subjects Interval 93.9 to 99.79

SECONDARY outcome

Timeframe: At 24 months of age (Visit 6)

Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.

To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.

Outcome measures

Outcome measures
Measure	MenACWY Group n=114 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup A	6.80 Titers Interval 5.19 to 8.93
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup C	13.04 Titers Interval 9.65 to 17.63
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup W	53.56 Titers Interval 40.42 to 70.97
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup Y	50.75 Titers Interval 38.76 to 66.45

SECONDARY outcome

Timeframe: At 24 months of age (Visit 6)

Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.

To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.

Outcome measures

Outcome measures
Measure	MenACWY Group n=108 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup A	2269.48 Titers Interval 1761.12 to 2924.59
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup C	17.17 Titers Interval 11.28 to 26.14
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup W	114.04 Titers Interval 65.22 to 199.39
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age Serogroup Y	310.91 Titers Interval 203.23 to 475.65

SECONDARY outcome

Timeframe: At 13 months of age (Visit 5)

Population: The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable hSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.

To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.

Outcome measures

Outcome measures
Measure	MenACWY Group n=122 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup A	107.90 Titers Interval 85.73 to 135.81
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup C	201.04 Titers Interval 157.9 to 255.96
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup W	426.74 Titers Interval 338.34 to 538.24
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age Serogroup Y	359.39 Titers Interval 280.59 to 460.31

SECONDARY outcome

Timeframe: At 13 months of age (Visit 5)

Population: The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.

To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.

Outcome measures

Outcome measures
Measure	MenACWY Group n=116 Participants Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. Serogroup A	7394.18 Titers Interval 6057.42 to 9025.93
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. Serogroup C	735.07 Titers Interval 545.22 to 991.03
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. Serogroup W	2718.69 Titers Interval 2031.77 to 3637.85
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. Serogroup Y	2226.70 Titers Interval 1731.21 to 2863.99

Adverse Events

MenACWY Group

Serious events: 26 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenACWY Group n=128 participants at risk Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Congenital, familial and genetic disorders Buried penis syndrome	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Enteritis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Bronchiolitis	3.9% 5/128 • Number of events 6 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Croup infectious	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Gastroenteritis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Hand-foot-and-mouth disease	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Herpangina	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pharyngitis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pharyngotonsillitis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia	3.1% 4/128 • Number of events 5 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia influenzal	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia parainfluenzae viral	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia respiratory syncytial viral	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia viral	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Tonsillitis	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Upper respiratory tract infection	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Urinary tract infection	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Viral infection	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Ligament rupture	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Tendon injury	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Nervous system disorders Seizure	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Contusion	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).

Other adverse events

Other adverse events
Measure	MenACWY Group n=128 participants at risk Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age.
Congenital, familial and genetic disorders Hydrocele	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Ear and labyrinth disorders Tympanic membrane perforation	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Eye disorders Eye discharge	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Eye disorders Retinal disorder	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Constipation	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Diarrhoea	32.0% 41/128 • Number of events 178 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Enteritis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Haematochezia	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Mouth ulceration	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Stomatitis	0.78% 1/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Gastrointestinal disorders Vomiting	32.8% 42/128 • Number of events 168 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Immune system disorders Atopy	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Immune system disorders Hypersensitivity	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Adenovirus infection	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Bronchiolitis	8.6% 11/128 • Number of events 14 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Bronchitis	8.6% 11/128 • Number of events 21 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Cellulitis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Croup infectious	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Ear infection	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Enterovirus infection	2.3% 3/128 • Number of events 4 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Exanthema subitum	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Gastroenteritis	7.0% 9/128 • Number of events 10 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Gastroenteritis viral	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Gianotti-Crosti syndrome	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Hand-foot-and-mouth disease	4.7% 6/128 • Number of events 6 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Herpangina	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Hordeolum	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Impetigo	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Nasopharyngitis	11.7% 15/128 • Number of events 18 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Oral candidiasis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Otitis externa	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Otitis media	3.9% 5/128 • Number of events 5 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Otitis media acute	8.6% 11/128 • Number of events 13 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Parainfluenzae virus infection	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pharyngitis	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pharyngotonsillitis	4.7% 6/128 • Number of events 6 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Pneumonia	3.9% 5/128 • Number of events 7 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Respiratory tract infection viral	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Rhinitis	4.7% 6/128 • Number of events 7 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Sinusitis	1.6% 2/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Tonsillitis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Upper respiratory tract infection	25.0% 32/128 • Number of events 52 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Infections and infestations Viral infection	3.1% 4/128 • Number of events 4 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Concussion	3.1% 4/128 • Number of events 4 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Contusion	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Ear canal injury	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Eye contusion	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Hand fracture	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Head injury	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Lip injury	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Radial head dislocation	0.78% 1/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Skin abrasion	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Skull fracture	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Injury, poisoning and procedural complications Thermal burn	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Metabolism and nutrition disorders Dehydration	1.6% 2/128 • Number of events 2 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Musculoskeletal and connective tissue disorders Arthritis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Renal and urinary disorders Hydronephrosis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Respiratory, thoracic and mediastinal disorders Cough	4.7% 6/128 • Number of events 7 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.1% 4/128 • Number of events 9 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Dermatitis	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Dermatitis contact	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Dry skin	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Eczema	3.1% 4/128 • Number of events 4 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Pityriasis alba	0.78% 1/128 • Number of events 1 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Rash	2.3% 3/128 • Number of events 3 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Skin and subcutaneous tissue disorders Urticaria	2.3% 3/128 • Number of events 4 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
General disorders Injection site pain	32.0% 41/128 • Number of events 136 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
General disorders Pyrexia	25.8% 33/128 • Number of events 68 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
General disorders Injection site induration	17.2% 22/128 • Number of events 67 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
General disorders Injection site erythema	12.5% 16/128 • Number of events 40 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Metabolism and nutrition disorders Hypophagia	46.1% 59/128 • Number of events 230 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Nervous system disorders Somnolence	52.3% 67/128 • Number of events 265 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).
Psychiatric disorders Irritability	67.2% 86/128 • Number of events 461 • Solicited local and systemic adverse events (AEs): from Day 1 to Day 7 after each vaccination. Unsolicited AEs, serious AEs (SAEs): From Day 1 to study end (visit 6).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER