Immunogenicity, Safety and Reactogenicity Study of GlaxoS... | NCT01978093

ID	Type	Description	Link
2013-003459-39	EudraCT Number

Label	Type	Description	Intervention Names
HibCY Group	Experimental	Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.	Biological: Hib-MenCY-TT (MenHibrix®) Biological: Pediarix® Biological: Rotarix® Biological: Prevnar 13® Biological: Havrix®
PedHIB Group	Active Comparator	Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.	Biological: Pediarix® Biological: Rotarix® Biological: Prevnar 13® Biological: PedvaxHIB® Biological: Havrix®

Name	Type	Description	Arm Group Labels	Other Names
Hib-MenCY-TT (MenHibrix®)	Biological	4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.

Measure	Description	Time Frame
Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL	Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.	1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]
Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).	Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch	2 months post-dose 2 of Rotarix (Month 4)
Anti-Streptococcus (S) Pneumoniae GMCs	Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.

Measure	Description	Time Frame
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.	The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35205	United States
GSK Investigational Site

ID	Title	Description
FG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

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 Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL

Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed.

Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.

The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Units	Counts
Participants	OG000223 OG001218

Title

Denominators

Categories

Title	Measurements
	OG00098.2(95.5 to 99.5) OG00197.2(94.1 to 99.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.	Group difference in proportions	Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached			Difference in percentage of subjects	0.96			2-Sided	95	-2.12	4.30					Non-Inferiority	Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).

Primary

Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).

Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.

Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch

The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.

Posted

Geometric Mean

95% Confidence Interval

U/mL

2 months post-dose 2 of Rotarix (Month 4)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group

Primary

Anti-Streptococcus (S) Pneumoniae GMCs

Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.

Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.

The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

1 month post-dose 3 of Prevnar 13 (Month 5)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001

Primary

Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL

Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL.

Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch

The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month post-dose 2 of Havrix (Month 17-20)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group

Primary

Anti-S. Pneumoniae GMCs

Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.

Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch

The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

1 month post-dose 4 of Prevnar 13 (Month 11-14)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group

Secondary

Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.

The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Anti-PRP GMCs≥ 0.15 µg/mL.

Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group

Secondary

Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL

The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.

The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY

The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Posted

Geometric Mean

95% Confidence Interval

Titres

1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL

The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

2 month post-dose 2 of Rotarix (Month 4)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL

The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.

Posted

Number

95% Confidence Interval

percentage of subjects

1 month post-dose 1 of Havrix (Month 11-14)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Anti-HAV GMCs ≥ 15 mIU/mL

The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

1 month post-dose 1 of HAV (M11-14).

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

GMCs for Anti-HAV Antibodies ≥15mIU/mL.

This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

1 month post-dose 2 of HAV (Month 17-20).

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups

This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).

Solicited local adverse events include pain, redness and swelling at injection site.

This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.

Posted

Number

95% Confidence Interval

Percentage of subjects

4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects Reporting Any Solicited General AEs.

Solicited general AEs include fever [defined as temperature ≥38.0 degrees Celsius (°C) by any method], drowsiness, irritability/fussiness and loss of appetite.

The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.

Posted

Number

95% Confidence Interval

Percentage of subjects

4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects Reporting Any Unsolicited AEs.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.

Posted

Number

95% Confidence Interval

Percentage of subjects

During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Secondary

Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Posted

Number

95% Confidence Interval

Percentage of subjects

During the entire study period (from Day 0 to Month 17-20)

ID	Title	Description
OG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
OG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0012 events1 affected303 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Abnormal faeces	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Acarodermatitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Administration site haemorrhage	General disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Administration site rash	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Aerophagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Animal bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Ankyloglossia congenital	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Aphonia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected297 at risk EG0011 events1 affected303 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0012 events2 affected303 at risk
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Body height below normal	Investigations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Body temperature increased	Investigations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Body tinea	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events5 affected297 at risk EG0014 events4 affected303 at risk
Bronchiolitis	Infections and infestations	Systematic Assessment	EG00013 events13 affected297 at risk EG0019 events9 affected303 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Burns second degree	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Cafe au lait spots	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Candida infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected297 at risk EG0014 events4 affected303 at risk
Candida nappy rash	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0014 events4 affected303 at risk
Cardiac murmur	Investigations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Cerumen impaction	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0014 events4 affected303 at risk
Communication disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Congenital torticollis	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Conjunctivitis	Infections and infestations	Systematic Assessment	EG00011 events11 affected297 at risk EG00117 events16 affected303 at risk
Conjunctivitis allergic	Eye disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Conjunctivitis bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00013 events13 affected297 at risk EG00111 events9 affected303 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected297 at risk EG0013 events3 affected303 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00024 events21 affected297 at risk EG00132 events31 affected303 at risk
Coxsackie viral infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Craniosynostosis	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Croup infectious	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG00110 events10 affected303 at risk
Cyanosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Dacryocystitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Dacryostenosis acquired	Eye disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Dacryostenosis congenital	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG000331 events177 affected297 at risk EG001384 events200 affected303 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00011 events11 affected297 at risk EG00115 events15 affected303 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00015 events14 affected297 at risk EG00113 events12 affected303 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00031 events26 affected297 at risk EG00120 events18 affected303 at risk
Drug hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Ear infection	Infections and infestations	Systematic Assessment	EG0009 events6 affected297 at risk EG0019 events5 affected303 at risk
Ear injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0014 events4 affected303 at risk
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0007 events7 affected297 at risk EG0018 events8 affected303 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Erythema infectiosum	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Exanthema subitum	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Eye discharge	Eye disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Eye infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Eye injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0011 events1 affected303 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events2 affected297 at risk EG0011 events1 affected303 at risk
Feeding disorder	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0006 events4 affected297 at risk EG0013 events3 affected303 at risk
Flushing	Vascular disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Fontanelle depressed	Nervous system disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Food allergy	Immune system disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0013 events3 affected303 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Frenulum breve	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Fungal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0014 events4 affected303 at risk
Fungal skin infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Furuncle	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0007 events7 affected297 at risk EG00112 events12 affected303 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected297 at risk EG00113 events13 affected303 at risk
Genital labial adhesions	Reproductive system and breast disorders	Systematic Assessment	EG0003 events3 affected297 at risk EG0012 events2 affected303 at risk
Genital rash	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Gingival pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Hand-foot-and-mouth disease	Infections and infestations	Systematic Assessment	EG0003 events3 affected297 at risk EG0014 events4 affected303 at risk
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected297 at risk EG0011 events1 affected303 at risk
Herpangina	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Hydrocele	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Hypermetropia	Eye disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Ill-defined disorder	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Impetigo	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Increased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Injection site bruising	General disorders	Systematic Assessment	EG0005 events5 affected297 at risk EG0013 events3 affected303 at risk
Injection site erythema	General disorders	Systematic Assessment	EG000442 events189 affected297 at risk EG001539 events211 affected303 at risk
Injection site induration	General disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0012 events2 affected303 at risk
Injection site mass	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Injection site pain	General disorders	Systematic Assessment	EG000550 events229 affected297 at risk EG001648 events248 affected303 at risk
Injection site rash	General disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Injection site reaction	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Injection site swelling	General disorders	Systematic Assessment	EG000322 events147 affected297 at risk EG001413 events182 affected303 at risk
Injection site warmth	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events1 affected303 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Irritability	Psychiatric disorders	Systematic Assessment	EG000737 events267 affected297 at risk EG001839 events284 affected303 at risk
Keratosis pilaris	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Lactose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Language disorder	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Laryngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Laryngomalacia	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Lethargy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Limb injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Lip injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Macrocephaly	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Middle ear effusion	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Miliaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Milk allergy	Immune system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Molluscum contagiosum	Infections and infestations	Systematic Assessment	EG0003 events2 affected297 at risk EG0011 events1 affected303 at risk
Motor developmental delay	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Multiple allergies	Immune system disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Mycoplasma infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Mycoplasma test positive	Investigations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Nail avulsion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00018 events15 affected297 at risk EG00115 events15 affected303 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00017 events16 affected297 at risk EG00114 events12 affected303 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0003 events3 affected297 at risk EG0012 events2 affected303 at risk
Oral mucosal eruption	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Oral pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Oropharyngeal candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0013 events3 affected303 at risk
Otitis externa	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Otitis media	Infections and infestations	Systematic Assessment	EG00048 events43 affected297 at risk EG00149 events41 affected303 at risk
Otitis media acute	Infections and infestations	Systematic Assessment	EG0006 events6 affected297 at risk EG0016 events5 affected303 at risk
Otorrhoea	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Pain	General disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Paronychia	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Penile adhesion	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Periorbital cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Peripheral swelling	General disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0005 events5 affected297 at risk EG0017 events6 affected303 at risk
Plagiocephaly	Congenital, familial and genetic disorders	Systematic Assessment	EG0006 events6 affected297 at risk EG0016 events6 affected303 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0003 events3 affected297 at risk EG0011 events1 affected303 at risk
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pneumonia streptococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Pneumonia viral	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pollakiuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Poor feeding infant	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Poor quality sleep	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Positional plagiocephaly	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0012 events2 affected303 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Pyrexia	General disorders	Systematic Assessment	EG000184 events124 affected297 at risk EG001235 events147 affected303 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00012 events9 affected297 at risk EG00114 events13 affected303 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Rash macular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Rash papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected303 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events6 affected297 at risk EG00112 events7 affected303 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Respiratory syncytial virus infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Respiratory tract infection viral	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Retching	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events4 affected297 at risk EG0014 events4 affected303 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00016 events14 affected297 at risk EG00121 events19 affected303 at risk
Roseola	Infections and infestations	Systematic Assessment	EG0002 events2 affected297 at risk EG0011 events1 affected303 at risk
Screaming	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Seasonal allergy	Immune system disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Seborrhoea	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0012 events2 affected303 at risk
Selective eating disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0005 events5 affected297 at risk EG0012 events2 affected303 at risk
Skin candida	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Skin injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Sleep disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG000569 events230 affected297 at risk EG001641 events254 affected303 at risk
Speech disorder	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Speech disorder developmental	Nervous system disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Staphylococcal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Strabismus	Eye disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected303 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Teething	Gastrointestinal disorders	Systematic Assessment	EG00013 events13 affected297 at risk EG00113 events13 affected303 at risk
Thermal burn	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Tongue injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Tonsillitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Tooth fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Torticollis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0015 events5 affected303 at risk
Umbilical granuloma	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Underweight	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG00078 events62 affected297 at risk EG00140 events35 affected303 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected297 at risk EG0014 events3 affected303 at risk
Vaccination site induration	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events1 affected303 at risk
Vaccination site nodule	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Vaccination site reaction	General disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Vaginal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Viral infection	Infections and infestations	Systematic Assessment	EG0008 events8 affected297 at risk EG0019 events9 affected303 at risk
Viral rash	Infections and infestations	Systematic Assessment	EG0005 events5 affected297 at risk EG0015 events4 affected303 at risk
Viral tonsillitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected297 at risk EG0015 events5 affected303 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00014 events14 affected297 at risk EG00124 events20 affected303 at risk
Vomiting projectile	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Vulvovaginal candidiasis	Infections and infestations	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected303 at risk
Weight	Investigations	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected303 at risk
Weight decreased	Investigations	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected303 at risk
Weight gain poor	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected297 at risk EG0012 events2 affected303 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events9 affected297 at risk EG0010 events0 affected303 at risk

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
C527605	Hib-MenCY-TT vaccine
C472675	PEDIARIX
C492457	RIX4414 vaccine
C538862	13-valent pneumococcal vaccine
C061964	Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine
D022362	Hepatitis A Vaccines

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
BG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HibCY Group	Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	1	297	8	297	282	297
EG001	PedHIB Group	Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	0	303	11	303	291	303