Immune Response Post Pry Vaccination of 2 Formulations of... | NCT00158756

NCT00158756

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tritanrix™-HepB+Rotarix™ Group	Experimental	Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Biological: Tritanrix™-HepB Biological: Rotarix™
Tritanrix™-HepB+Placebo Group	Experimental	Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Biological: Tritanrix™-HepB Drug: Placebo
Zilbrix™+Rotarix™ Group	Active Comparator	Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Biological: Rotarix™ Biological: Zilbrix™
Zilbrix™+Placebo Group	Active Comparator	Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Biological: Zilbrix™ Drug: Placebo
Triple Antigen™+Engerix™-B Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tritanrix™-HepB	Biological	GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.	Tritanrix™-HepB+Placebo Group Tritanrix™-HepB+Rotarix™ Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies	Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.	At one month post dose 3 [PIII(M4)]

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA	A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.	At one month post dose 3 [PIII(M4)]
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Barnaul		656049	Russia
GSK Investigational Site

References Module

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
104021	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
FG001	Tritanrix-HepB+Placebo Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
BG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
BG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
BG003	Zilbrix+Placebo Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
BG004	Triple Antigen+Engerix-B Group	Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Weeks

Title

Denominators

Categories

Title	Measurements
	OG000100(94.7 to 100) OG001100(83.2 to 100) OG002100(94.2 to 100) OG003

Secondary

Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA

A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.

Posted

Number

Subjects

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies

A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).

Posted

Number

Subjects

At one most post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values

A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).

Posted

Number

Subjects

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group

Secondary

Number of Subjects With Vaccine Response to BPT Antigen

Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.

Posted

Number

Subjects

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group

Secondary

Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values

A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).

Posted

Number

Subjects

At 2.5 months after dose 2 of Rotarix [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen

A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).

Posted

Number

Subjects

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)

A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8

Posted

Number

Subjects

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Concentrations of Anti-HBs Antibodies

Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Concentrations of Anti-DT Antibodies

Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Concentrations of Anti-T Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Concentrations of Anti-BPT Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Concentrations of Anti-RV Antibodies

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.

Posted

Geometric Mean

95% Confidence Interval

U/mL

At 2.5 months post dose 2 of Rotarix [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Anti-Polio Type 1, 2, 3 Antibody Titers

Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At one month post dose 3 [PIII(M4)]

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Subjects With Solicited Local Symptoms

Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).

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

Posted

Number

Subjects

During the 8-Day (Days 0-7) follow-up period

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Subjects With Any Solicited General Symptoms

Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.

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

Posted

Number

Subjects

During the 8-day period (Days 0-7) post-vaccination

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

Number of subjects with any 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 and the symptom sheet filled in.

Posted

Number

Subjects

During the 31-day (Days 0-30) follow-up period

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.

Secondary

Number of Subjects With 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.

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

Posted

Number

Subjects

From Month 0 to Month 4

ID	Title	Description
OG000	Tritanrix-HepB+Rotarix Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.
OG001	Tritanrix-HepB+Placebo Group	Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.
OG002	Zilbrix+Rotarix Group	Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tritanrix™-HepB+Rotarix™ Group	Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	1	80	74	80
EG001	Tritanrix™-HepB+Placebo Group	Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	0	25	25	25
EG002	Zilbrix™+Rotarix™ Group	Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	7	81	74	81
EG003	Zilbrix™+Placebo Group	Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	0	23	22	23
EG004	Triple Antigen™+Engerix™-B Group	Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.	2	99	96	99

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected80 at risk EG0010 affected25 at risk EG0023 affected81 at risk EG0030 affected23 at risk EG004
Enterocolitis infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0023 affected81 at risk EG003
Anemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0022 affected81 at risk EG003
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0021 affected81 at risk EG003
Injection site abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0021 affected81 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0021 affected81 at risk EG003
Laryngotracheitis obstructive	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0020 affected81 at risk EG003
Overgrowth bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0021 affected81 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected80 at risk EG0010 affected25 at risk EG0021 affected81 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected80 at risk EG0011 affected25 at risk EG0023 affected81 at risk EG0032 affected23 at risk EG0045 affected99 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected80 at risk EG0013 affected25 at risk EG0021 affected81 at risk EG003
Pain	General disorders	MedDRA	Systematic Assessment	EG00051 affected78 at risk EG00117 affected25 at risk EG00258 affected76 at risk EG003
Redness	General disorders	MedDRA	Systematic Assessment	EG00060 affected78 at risk EG00120 affected25 at risk EG00265 affected76 at risk EG003
Swelling	General disorders	MedDRA	Systematic Assessment	EG00044 affected78 at risk EG00116 affected25 at risk EG00252 affected76 at risk EG003
Diarrhea	General disorders	MedDRA	Systematic Assessment	EG0008 affected78 at risk EG0010 affected25 at risk EG0026 affected77 at risk EG003
Drowsiness	General disorders	MedDRA	Systematic Assessment	EG00058 affected78 at risk EG00119 affected25 at risk EG00254 affected77 at risk EG003
Fever	General disorders	MedDRA	Systematic Assessment	EG00054 affected78 at risk EG00120 affected25 at risk EG00259 affected77 at risk EG003
Irritability	General disorders	MedDRA	Systematic Assessment	EG00061 affected78 at risk EG00123 affected25 at risk EG00266 affected77 at risk EG003
Loss of appetite	General disorders	MedDRA	Systematic Assessment	EG00043 affected78 at risk EG00114 affected25 at risk EG00239 affected77 at risk EG003
Vomiting	General disorders	MedDRA	Systematic Assessment	EG00012 affected78 at risk EG0012 affected25 at risk EG00212 affected77 at risk EG003

ID	Term
D006509	Hepatitis B
D004165	Diphtheria
D014917	Whooping Cough
D013742	Tetanus

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
D003015	Clostridium Infections

ID	Term
C492457	RIX4414 vaccine

OG00498.9(93.8 to 100)

Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.

EG0040 affected99 at risk

EG0041 affected99 at risk

EG0040 affected99 at risk

EG00462 affected98 at risk

EG00477 affected98 at risk

EG00457 affected98 at risk

EG0044 affected98 at risk

EG00468 affected98 at risk

EG00480 affected98 at risk

EG00484 affected98 at risk

EG00448 affected98 at risk

EG00420 affected98 at risk

OG004825.9(661.7 to 1031.0)

OG004351.3(267.5 to 461.3)