Primary Vaccination Study With a Pneumococcal Conjugate V... | NCT00814710

NCT00814710

ID	Type	Description	Link
2011-004644-22	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synflorix & Tritanrix-HebB/Hib Group	Experimental	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Tritanrix-HepB/Hib
Hiberix group & Tritanrix-HebB Group	Active Comparator	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Biological: Hiberix Biological: Tritanrix-HepB

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal conjugate vaccine GSK1024850A	Biological	Intramuscular injection, 3 doses	Synflorix & Tritanrix-HebB/Hib Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes	Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.	One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)	Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	One month after primary immunization (month 3)

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes	Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
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).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Babies for which birth weight is < 2 kilogram.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Kolkata		700073	India
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22634448	Background	Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
25008901

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
111188	Study Protocol	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
FG001	Hiberix Group and Tritanrix-HepB Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
BG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
BG002	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

Anti-1

Title	Measurements
	OG0003.27(2.91 to 3.67) OG0010.03(0.03 to 0.04)

Anti-4

Title	Measurements
	OG000

Primary

Concentration of Antibody Against Protein D (PD)

Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units

Secondary

Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes

Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Number of Subjects Seropositive for Pneumococcal Serotypes

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Number of Subjects Seropositive for Protein D (PD)

Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants	OG000

Secondary

Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)

Concentration is expressed as GMC in µg/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants	OG000

Secondary

Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)

Concentrations were expressed as GMCs in international units per milliliter (IU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)

Concentration was expressed as GMC in EL.U/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants	OG000

Secondary

Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).

Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts

Secondary

Number of Subjects Seropostive for B. Pertussis

Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants	OG000

Secondary

Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)

Seroprotection was defined as:

Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)

Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Posted

Number

subjects

One month after primary immunization (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Solicited Local and General Symptoms

Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.

Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.

Posted

Number

subjects

Within 4 days (day 0-3) after vaccination

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

An AE is 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.

Unsolicited AE covers any AE 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

Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

subjects

Within 31 days (day 0-30) after vaccination

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Number

subjects

Following first vaccination (Month 0) throughout the entire study period (month 3)

ID	Title	Description
OG000	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
OG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Units	Counts
Participants

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	Synflorix and Tritanrix-HepB/Hib Group	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)			5	240	231	240
EG001	Hiberix Group and Tritanrix-HepB Group	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)			1	120	114	120

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedRA	Non-systematic Assessment	EG0003 affected240 at risk EG0010 affected120 at risk
Bronchopneumonia	Infections and infestations	MedRA	Non-systematic Assessment	EG0002 affected240 at risk EG0011 affected120 at risk
Chikungunya virus infection	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk
Gastroenteritis	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk
Pyrexia	General disorders	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk
Sepsis	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedRA	Non-systematic Assessment	EG0001 affected240 at risk EG0010 affected120 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders		Systematic Assessment	EG000209 affected238 at risk EG001105 affected119 at risk
Redness	General disorders		Systematic Assessment	EG000128 affected238 at risk EG00176 affected119 at risk
Swelling	General disorders		Systematic Assessment	EG000166 affected238 at risk EG00183 affected119 at risk
Drowsiness	General disorders		Systematic Assessment	EG00073 affected238 at risk EG00134 affected119 at risk
Fever	General disorders		Systematic Assessment	EG000182 affected238 at risk EG00185 affected119 at risk
Irritability	General disorders		Systematic Assessment	EG000178 affected238 at risk EG00188 affected119 at risk
Loss of appetite	General disorders		Systematic Assessment	EG00096 affected238 at risk EG00149 affected119 at risk
Rhinitis	Infections and infestations	MedRA	Non-systematic Assessment	EG00013 affected240 at risk EG0016 affected120 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedRA	Non-systematic Assessment	EG00013 affected240 at risk EG0014 affected120 at risk

ID	Term
D013290	Streptococcal Infections
D011008	Pneumococcal Infections

ID	Term
C514867	Hiberix
C524362	Tritanrix-HepB vaccine

OG0010.04(0.03 to 0.05)

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections