Evaluation of the Immunogenicity, Safety and Reactogenici... | NCT00290342

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infanrix-IPV Group	Experimental	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.	Biological: DTPa-IPV
Infanrix + IMOVAX Polio Group	Active Comparator	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.	Biological: DTPa Biological: IMOVAX Polio®

Name	Type	Description	Arm Group Labels	Other Names
DTPa-IPV	Biological	3 intramuscular injections	Infanrix-IPV Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)	A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).	One month (Month 5) post-primary vaccination course
Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3	A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.	One month (Month 5) post-primary vaccination course
Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)	Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.	One month (Month 5) post-primary vaccination course
Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens	Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).	One month (Month 5) post-primary vaccination course

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)	A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).	Before (Pre) and one month after (Post) the primary vaccination course

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bucheon-si		420-767	South Korea
GSK Investigational Site

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
104871	Study Protocol	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
BG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000224 BG001228 BG002452

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 Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Posted

Number

Subjects

One month (Month 5) post-primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Units	Counts
Participants	OG000204 OG001211

Title

Denominators

Categories

Anti-D

Title	Measurements
	OG000204 OG001211

Anti-T

Title	Measurements
	OG000

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	Non-inferiority in terms of vaccine response to diphteria					Difference in seroprotection rate	0			2-Sided	95	-1.85	1.79					Non-Inferiority or Equivalence	To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.

Primary

Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3

A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.

Posted

Number

Subjects

One month (Month 5) post-primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Primary

Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)

Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.

Posted

Number

Subjects

One month (Month 5) post-primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Primary

Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens

Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).

Posted

Number

Subjects

One month (Month 5) post-primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

Posted

Number

Subjects

Before (Pre) and one month after (Post) the primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Before (Pre) and one month after (Post) the primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Titers for Poliovirus Type 1, 2 and 3 Antibodies

Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before (Pre) and one month after (Post) the primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Before (Pre) and one month after (Post) the primary vaccination course

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying 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 vaccinated subjects for whom data were available and who had the symptom sheet filled-in.

Posted

Number

Subjects

During the 4-day (Days 0-3) post-vaccination period, across doses

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Number of Subjects Reporting 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 > 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.

Posted

Number

Subjects

During the 4-day (Days 0-3) post-vaccination period, across doses

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Number of Subjects Reporting 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 vaccinated subjects for whom data were available.

Posted

Number

Subjects

During the 31-day (Days 0-30) post-vaccination period

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Secondary

Number 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.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Posted

Number

Subjects

During the entire study period (from Month 0 up to Month 5)

ID	Title	Description
OG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
OG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Infanrix-IPV Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.			15	224	200	224
EG001	Infanrix + IMOVAX Polio Group	Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.			17	228	196	228

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Patent ductus arteriosus	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 affected224 at risk EG0011 affected228 at risk
Febrile convulsion	Nervous system disorders	Systematic Assessment	EG0001 affected224 at risk EG0010 affected228 at risk
Pyrexia	General disorders	Systematic Assessment	EG0002 affected224 at risk EG0011 affected228 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected224 at risk EG0012 affected228 at risk
Hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0001 affected224 at risk EG0010 affected228 at risk
Bronchiolitis	Infections and infestations	Systematic Assessment	EG0007 affected224 at risk EG0013 affected228 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0004 affected224 at risk EG0015 affected228 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0003 affected224 at risk EG0015 affected228 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0002 affected224 at risk EG0012 affected228 at risk
Kawasaki's disease	Infections and infestations	Systematic Assessment	EG0000 affected224 at risk EG0011 affected228 at risk
Otitis media acute	Infections and infestations	Systematic Assessment	EG0001 affected224 at risk EG0010 affected228 at risk
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0001 affected224 at risk EG0010 affected228 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 affected224 at risk EG0010 affected228 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bronchiolitis	Infections and infestations	Systematic Assessment	EG00014 events14 affected224 at risk EG00111 events7 affected228 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0008 events7 affected224 at risk EG00112 events12 affected228 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG000130 events84 affected224 at risk EG001115 events78 affected228 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00018 events16 affected224 at risk EG00120 events17 affected228 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00016 events12 affected224 at risk EG0018 events8 affected228 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG000212 events115 affected224 at risk EG001209 events116 affected228 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG00011 events10 affected224 at risk EG00114 events13 affected228 at risk
Irritability	Psychiatric disorders	Systematic Assessment	EG000238 events140 affected224 at risk EG001241 events139 affected228 at risk
Pain	General disorders	Systematic Assessment	EG000164 events92 affected224 at risk EG001161 events96 affected228 at risk
Pyrexia	General disorders	Systematic Assessment	EG00091 events74 affected224 at risk EG00148 events40 affected228 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG000152 events95 affected224 at risk EG001161 events99 affected228 at risk
Swelling	General disorders	Systematic Assessment	EG000114 events74 affected224 at risk EG001129 events79 affected228 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG00098 events72 affected224 at risk EG00188 events61 affected228 at risk

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections

ID	Term
C451839	DTPa-HBV-IPV combined vaccine
D004369	Pentetic Acid
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit