Immune Memory of DTPw-HBV/Hib Vaccine Following Primary V... | NCT00169442

Label	Type	Description	Intervention Names
Tritanrix-HepB/Hiberix Kft. Mix Group	Experimental	Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Biological: Tritanrix™-HepB/Hiberix™ Kft.
Tritanrix-HepB/Hiberix Kft. Ref Group	Experimental	Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Biological: Tritanrix™-HepB/Hiberix™ Kft. Biological: Tritanrix™-HepB/Hiberix™
HB Tritanrix-HepB/Hiberix Kft. Mix Group	Experimental	Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Biological: Tritanrix™-HepB/Hiberix™ Kft.
Tritanrix-HepB Kft.+Hiberix Group	Experimental	Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

Name	Type	Description	Arm Group Labels	Other Names
Tritanrix™-HepB/Hiberix™ Kft.	Biological	GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.

Measure	Description	Time Frame
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL	The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.	At Month 1, post-PRP challenge
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.	The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.	At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)	A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).	At Month 1, post-booster vaccination
Seroprotection Rates for Anti-D Antibodies	The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.	At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)	A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).	At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)

Measure	Description	Time Frame
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL	The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.	At Month 0, prior to the PRP challenge
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		City of Muntinlupa		1781	Philippines
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
	Background	Gatchalian et al. A new DTPw-HBV/Hib vaccine: Immunogenic and safe for primary vaccination and booster dosing in the second year of life - 5th World Congress WSPID, Bangkok, Thailand, 15-18 Nov 2007
18376148	Background	Gatchalian S, Reyes M, Bermal N, Chandrasekaran V, Han HH, Bock HL, Lefevre I. A new DTPw-HBV/Hib vaccine: immune memory after primary vaccination and booster dosing in the second year of life. Hum Vaccin. 2008 Jan-Feb;4(1):60-6. doi: 10.4161/hv.4.1.5069. Epub 2007 Sep 23.

Label	URL
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ID	Type	URL	Comment
104065	Study Protocol	View IPD

ID	Title	Description
FG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
FG001	Tritanrix-HepB/Hiberix Kft. Ref Group

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

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Units	Counts
Participants	OG00039 OG00141

Title

Denominators

Categories

Anti-PRP ≥ 0.15 μg/mL

Title	Measurements
	OG00039 OG00141

Anti-PRP ≥ 1.0 μg/mL

Title	Measurements
	OG000

Primary

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)

A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Seroprotection Rates for Anti-D Antibodies

The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Number

95% Confidence Interval

Proportion

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group

Primary

Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)

A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)

A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Number of Subjects With Booster Response to BPT Antigen

The booster response was defined as:

an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or
at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Anti-PRP Antibody Concentrations

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

At Month 1, post-PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Anti-PRP Antibody Concentrations.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Anti-D and Anti-T Antibody Concentrations

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Anti-HBs Antibody Concentrations

Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Primary

Anti-BPT Antibody Concentrations

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Month 1, post-booster vaccination

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value

The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group

Secondary

Seroprotection Rates for Anti-D Antibodies

The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Number

95% Confidence Interval

Proportion

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group

Secondary

Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value

The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value

The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Count of Participants

Participants

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Anti- PRP Antibody Concentrations

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Anti- PRP Antibody Concentrations.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Anti-D and Anti-T Antibody Concentrations.

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Anti-HBs Antibody Concentrations.

Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Anti-BPT Antibody Concentrations.

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Month 0, prior to the PRP challenge

ID	Title	Description
OG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 4-Day (Days 0-3) post-PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 4-Day (Days 0-3) post-PRP challenge

ID	Title	Description
OG000	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
OG001	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 4-Day (Days 0-3) post-booster vaccination period

ID	Title	Description
OG000	PRP Pooled Group	PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
OG001	Mix Pooled Group	Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
OG002	Tritanrix-HepB Kft.+Hiberix Group	Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 4-Day (Days 0-3) post-booster vaccination period

ID	Title	Description
OG000	PRP Pooled Group	PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
OG001	Mix Pooled Group	Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
OG002	Tritanrix-HepB Kft.+Hiberix Group

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 31-Day (Day 0-30) follow-up period

ID	Title	Description
OG000	PRP Pooled Group	PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
OG001	Mix Pooled Group	Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
OG002	Tritanrix-HepB Kft.+Hiberix Group	Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (from Month 0 to Month 9.5)

ID	Title	Description
OG000	PRP Pooled Group	PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
OG001	Mix Pooled Group	Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
OG002	Tritanrix-HepB Kft.+Hiberix Group	Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PRP Pooled Group	PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.	85	1	85	77	85
EG001	Mix Pooled Group	Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.	410	0	410	379	410
EG002	Tritanrix-HepB Kft.+Hiberix Group	Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	250	0	250	231	250
EG003	PRP TRITANRIX-HEPB KFT. MIX GROUP	Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .	0	0	0	37	42
EG004	PRP TRITANRIX-HEPB KFT. REF GROUP	Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .	0	0	0	40	43

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0008 affected85 at risk EG0018 affected410 at risk EG0028 affected250 at risk EG0030 affected42 at risk EG0040 affected43 at risk
Pain (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00056 affected82 at risk EG001303 affected409 at risk EG002181 affected250 at risk EG003
Redness (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00046 affected82 at risk EG001255 affected409 at risk EG002152 affected250 at risk EG003
Swelling (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00044 affected82 at risk EG001250 affected409 at risk EG002140 affected250 at risk EG003
Drowsiness (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00034 affected82 at risk EG001174 affected409 at risk EG002105 affected250 at risk EG003
Fever (Axillary) (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00059 affected82 at risk EG001270 affected409 at risk EG002168 affected250 at risk EG003
Iritability (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00054 affected82 at risk EG001267 affected409 at risk EG002162 affected250 at risk EG003
Loss of appetite (post-booster)	General disorders	MedDRA 9.0	Systematic Assessment	EG00025 affected82 at risk EG001129 affected409 at risk EG00279 affected250 at risk EG003
Pain (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Redness (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Swelling (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Drowsiness (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Fever (Axillary) (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Irritability (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Loss of appetite (post-PRP challenge)	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003

ID	Term
D004165	Diphtheria
D006509	Hepatitis B
D013742	Tetanus
D006192	Haemophilus Infections

ID	Term
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D003015	Clostridium Infections
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections

ID	Term
C514867	Hiberix
D014612	Vaccines

ID	Title	Description
BG000	Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
BG001	Tritanrix-HepB/Hiberix Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
BG002	HB Tritanrix-HepB/Hiberix Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
BG003	Tritanrix-HepB Kft.+Hiberix Group	Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
BG004	PRP Tritanrix-HepB Kft. Mix Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
BG005	PRP Tritanrix-HepB Kft. Ref Group	Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
BG006	Total	Total of all reporting groups