A Study to Assess the Immunogenicity and Safety of GSK Bi... | NCT02858440

ID	Type	Description	Link
2013-005577-43	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
DTPa-IPV/Hib Group	Experimental	All subjects receive three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.	Biological: Infanrix-IPV/Hib

Name	Type	Description	Arm Group Labels	Other Names
Infanrix-IPV/Hib	Biological	Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination	A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).	At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination	A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.	At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination	A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).	At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination	A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.	At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination	A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.	At Month 16 (i.e. one month after booster vaccination)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female child between 3 and 4 months of age at the time of the first vaccination.
Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born full-term.

Exclusion Criteria:

Child in care
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
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 vaccine/product
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects.
Serious chronic illness.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
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		Barnaul		656056	Russia
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
32048889	Derived	Romanenko V, Osipova I, Galustyan A, Scherbakov M, Baudson N, Farhi D, Anaya L, Kuriyakose SO, Meyer N, Janssens W. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course and a booster dose in healthy children in Russia: a phase III, non-randomized, open-label study. Hum Vaccin Immunother. 2020 Sep 1;16(9):2265-2273. doi: 10.1080/21645515.2020.1720437. Epub 2020 Feb 12.

ID	Title	Description
FG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 11, 2016	May 8, 2019

ID	Title	Description
BG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	BG000235

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 for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination

A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).

The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

Posted

Count of Participants

Participants

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000176

Title

Denominators

Categories

Anti-D antibody ≥ 0.1 IU/mL

Title	Measurements
	OG000176

Anti-T antibody ≥ 0.1 IU/mL

Title	Measurements
	OG000176

Primary

Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination

A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.

Posted

Count of Participants

Participants

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Primary

Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination

A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).

Posted

Count of Participants

Participants

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Primary

Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination

A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.

Posted

Count of Participants

Participants

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination

A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.

The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

Posted

Count of Participants

Participants

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination

A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.

Posted

Count of Participants

Participants

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination

A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.

Posted

Count of Participants

Participants

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination

A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.

Posted

Count of Participants

Participants

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination

The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination

The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination

The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination

The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentration for Anti-PRP, Post Primary Vaccination

The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentration for Anti-PRP, Post Booster Vaccination

The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination

The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 4 (i.e. one month after 3rd dose of primary vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination

The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 16 (i.e. one month after booster vaccination)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination

The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

Total vaccinated cohort (TVC) for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any Solicited Local AEs Following Booster Vaccination

The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination

The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.

TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any Solicited General AEs Following Booster Vaccination

Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination

An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.

TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Unsolicited AEs Following Booster Vaccination

Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.

TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented, and TVC for analysis of safety of the booster epoch: all subjects with the booster vaccine dose administration documented.

Posted

Count of Participants

Participants

During the entire study period (i.e. from Day 0 until Month 16)

ID	Title	Description
OG000	DTPa-IPV/Hib Group	All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agitation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected235 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected235 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000150 events93 affected235 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected235 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Dystonia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Ear infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Food allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Idiopathic intracranial hypertension	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Infantile colic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected235 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG000369 events140 affected235 at risk
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG000226 events103 affected235 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG000239 events102 affected235 at risk
Nightmare	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Motor dysfunction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected235 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Poor quality sleep	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG000104 events67 affected235 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected235 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Regurgitation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected235 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00018 events15 affected235 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG000270 events131 affected235 at risk
Tracheitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 events4 affected235 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Varicella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected235 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Irritability postvaccinal	General disorders	MedDRA 21.0	Systematic Assessment	EG000398 events157 affected235 at risk
Enteritis infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected235 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk

ID	Term
D004165	Diphtheria
D013742	Tetanus
D014917	Whooping Cough
D006509	Hepatitis B
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
D003015	Clostridium Infections
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
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
D016871	Pasteurellaceae Infections

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Proctitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Gastric infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected235 at risk