Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conj... | NCT01214837

Label	Type	Description	Intervention Names
MenACWY3	Experimental	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	Biological: MenACWY-CRM Biological: Routine Vaccines
MenACWY4	Experimental	All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Biological: MenACWY-CRM Biological: Routine Vaccines
Routine Vaccines	Placebo Comparator	Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.	Biological: Routine Vaccines

Name	Type	Description	Arm Group Labels	Other Names
MenACWY-CRM	Biological	This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Measure	Description	Time Frame
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.	The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.	13 months of age
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.	The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.	13 months of age

Measure	Description	Time Frame
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.	Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.	Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age

PubMed Identifier	Type	Citation	Retractions
26479973	Derived	Block SL, Shepard J, Garfield H, Xie F, Han L, Dull PM, Smolenov I. Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48-59. doi: 10.1097/INF.0000000000000965.

ID	Title	Description
FG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
FG001	MenACWY4	All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.

The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.

Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.

Posted

Number

95% Confidence Interval

Percentage of subjects

13 months of age

ID	Title	Description
OG000	MenACWY4	All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants	OG000152

Title

Denominators

Categories

Serogroup A (N=141)

Title	Measurements
	OG00096(91 to 98)

Serogroup C

Title	Measurements
	OG00099(95 to 100)

Serogroup W (N=138)

Primary

Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.

Analysis was done on Toddler PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

13 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants

Secondary

Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.

Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.

Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.

Posted

Number

95% Confidence Interval

Percentages of subjects

Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Secondary

Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.

Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.

Analysis was done on the Infant PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Secondary

Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.

Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

Analysis was done on the Toddler PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

12 months of age.

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants	OG000

Secondary

Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.

The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

Analysis was done on the Toddler PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

12 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants	OG000

Secondary

GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.

Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.

Analysis was done on the Toddler PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

13 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.

The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.

Analysis was done on the Toddler PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

13 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Units	Counts
Participants	OG000

Secondary

Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.

Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.

Analysis was done on the Infant PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

7 months of age.

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Secondary

Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.

Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.

Analysis was done on the Toddler PPS.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

13 months of age.

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Units

Secondary

Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.

Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.

Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data

Posted

Number

Percentage of subjects

Within 7 days

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Secondary

Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.

Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.

Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data

Posted

Number

Subjects

Day 1 through Day 7

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.

Posted

Number

Subjects

13 months of age

ID	Title	Description
OG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
OG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
OG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Congenital megacolon	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Krabbe's disease	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Laryngomalacia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Anal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Abdominal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Atypical pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected242 at risk EG0012 affected252 at risk EG0024 affected239 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Croup infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Otitis media acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Rectal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Respiratory synctial virus bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected242 at risk EG0015 affected252 at risk EG0022 affected239 at risk
Staphylococcal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0012 affected252 at risk EG0020 affected239 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Nystagmus	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Breath holding	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0011 affected252 at risk EG0020 affected239 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected242 at risk EG0010 affected252 at risk EG0020 affected239 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected242 at risk EG0010 affected252 at risk EG0021 affected239 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG00013 affected242 at risk EG00110 affected252 at risk EG0029 affected239 at risk
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment	EG00042 affected242 at risk EG00125 affected252 at risk EG00240 affected239 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00010 affected242 at risk EG00121 affected252 at risk EG00219 affected239 at risk
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000103 affected242 at risk EG00178 affected252 at risk EG00280 affected239 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00011 affected242 at risk EG00114 affected252 at risk EG00227 affected239 at risk
Teething	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00015 affected242 at risk EG00113 affected252 at risk EG00219 affected239 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00076 affected242 at risk EG00168 affected252 at risk EG00267 affected239 at risk
Crying	General disorders	MedDRA	Systematic Assessment	EG000140 affected242 at risk EG001138 affected252 at risk EG002112 affected239 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG00087 affected242 at risk EG00180 affected252 at risk EG00289 affected239 at risk
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG00065 affected242 at risk EG00145 affected252 at risk EG00279 affected239 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG000137 affected242 at risk EG001140 affected252 at risk EG002138 affected239 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG000181 affected242 at risk EG001179 affected252 at risk EG002157 affected239 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00088 affected242 at risk EG00187 affected252 at risk EG00269 affected239 at risk
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00034 affected242 at risk EG00136 affected252 at risk EG00230 affected239 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0008 affected242 at risk EG00119 affected252 at risk EG00217 affected239 at risk
Candida nappy rash	Infections and infestations	MedDRA	Non-systematic Assessment	EG00013 affected242 at risk EG0016 affected252 at risk EG0027 affected239 at risk
Croup Infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG00013 affected242 at risk EG00116 affected252 at risk EG00216 affected239 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00022 affected242 at risk EG00118 affected252 at risk EG00227 affected239 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG00094 affected242 at risk EG00177 affected252 at risk EG00289 affected239 at risk
Otitis media acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG00023 affected242 at risk EG00119 affected252 at risk EG00216 affected239 at risk
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00020 affected242 at risk EG00117 affected252 at risk EG00215 affected239 at risk
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0009 affected242 at risk EG00117 affected252 at risk EG0027 affected239 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG000105 affected242 at risk EG001107 affected252 at risk EG002106 affected239 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00038 affected242 at risk EG00132 affected252 at risk EG00230 affected239 at risk
Viral rash	Infections and infestations	MedDRA	Non-systematic Assessment	EG00010 affected242 at risk EG00110 affected252 at risk EG00213 affected239 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG000162 affected242 at risk EG001154 affected252 at risk EG002158 affected239 at risk
Eating disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG000104 affected242 at risk EG001104 affected252 at risk EG00293 affected239 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00032 affected242 at risk EG00132 affected252 at risk EG00237 affected239 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00016 affected242 at risk EG00118 affected252 at risk EG00214 affected239 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00012 affected242 at risk EG0019 affected252 at risk EG00216 affected239 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00010 affected242 at risk EG00111 affected252 at risk EG00214 affected239 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00038 affected242 at risk EG00131 affected252 at risk EG00222 affected239 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00016 affected242 at risk EG00119 affected252 at risk EG00220 affected239 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00029 affected242 at risk EG00131 affected252 at risk EG00235 affected239 at risk
Candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00014 affected242 at risk EG00120 affected252 at risk EG00221 affected239 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D008589	Meningococcal Infections
D008585	Meningitis, Meningococcal
D008581	Meningitis

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000090862	Neuroinflammatory Diseases

ID	Title	Description
BG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
BG001	MenACWY4	All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
BG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MenACWY3	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	11	242	238	242
EG001	MenACWY4	Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	19	252	233	252
EG002	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.	11	239	228	239