Study in Toddlers to Demonstrate Non-inferiority of GSK B... | NCT00326118

ID	Type	Description
106446	Other Identifier	GSK
106449	Other Identifier	GSK
106450	Other Identifier	GSK
106452	Other Identifier	GSK
106454	Other Identifier	GSK

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meningitec + Hiberix Group	Active Comparator	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.	Biological: Priorix™ Biological: Hiberix™ Biological: Meningitec™
Menitorix Group	Experimental	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.	Biological: Haemophilus influenzae type b and meningococcal serogroup C (vaccine) Biological: Priorix™

Name	Type	Description	Arm Group Labels	Other Names
Haemophilus influenzae type b and meningococcal serogroup C (vaccine)	Biological	One intramuscular dose at 12-18 months of age	Menitorix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)	Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.	1 month after vaccination
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer	rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.	1 month after vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values	rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary phase:

Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 18 months of age at the time of vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.

Long-term persistence phase:

- Having participated in the vaccination study 106445

Exclusion Criteria:

For the primary vaccination phase:

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) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
Previous administration of a booster dose of Hib vaccine.
Previous vaccination against measles, mumps, rubella.
History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of neurological disorders or more than one episode of febrile convulsion.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional exclusion criteria for the long-term persistence phase: to be checked each year.

Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
History of H. influenzae type b, meningococcal serogroup C diseases.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Garran	Australian Capital Territory	2606	Australia
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21068692	Background	Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.
23080288

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
106445	Statistical Analysis Plan	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
FG001	Meningitec + Hiberix Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
BG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)

Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.

The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.

Posted

Number

Subjects

1 month after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Units	Counts
Participants	OG000292 OG001100

Title

Denominators

Categories

Title	Measurements
	OG000292 OG001100

Primary

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer

rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.

Posted

Number

Subjects

1 month after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values

rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.

Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.

Posted

Number

Subjects

Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group

Secondary

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values

rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.

Posted

Number

Subjects

5 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm

Secondary

Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers

Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.

Posted

Geometric Mean

95% Confidence Interval

Titer

Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.

Posted

Geometric Mean

95% Confidence Interval

Titer

5 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values

Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).

Posted

Number

Subjects

Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values

Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.

Posted

Number

Subjects

5 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs).

Posted

Geometric Mean

95% Confidence Interval

microgram per milliliter (µg/mL)

Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.

Posted

Geometric Mean

95% Confidence Interval

microgram per milliliter (µg/mL)

5 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Units	Counts

Secondary

Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values

Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.

Posted

Number

Subjects

Prior to, 1 month, 1 year, 2 years and 3 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Anti-polysaccharide C (Anti-PSC) Antibody Concentrations

Concentrations given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.

Posted

Geometric Mean

95% Confidence Interval

micrograms per milliliter (µg/mL)

Prior to, 1 month, 1 year, 2 years and 3 years after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.

Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.

Posted

Number

Subjects

Within 4 days (Day 0 -Day 3) after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Units	Counts

Secondary

Number of Subjects Reporting Unsolicited Symptoms

Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.

Posted

Number

Subjects

Within 31 days (Day 0 - Day 30) after vaccination

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Units

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs)

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.

For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.

Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.

Posted

Number

Subjects

Throughout the entire study period (up to year 5)

ID	Title	Description
OG000	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
OG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

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	Menitorix Group	Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.			4	324	293	324
EG001	Meningitec + Hiberix Group	Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.			2	109	104	109

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected109 at risk
Breath holding	Psychiatric disorders	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected109 at risk
Convulsion	Nervous system disorders	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected109 at risk
Croup infectious	Infections and infestations	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected109 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected109 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected109 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected109 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected109 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected109 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00054 affected324 at risk EG00113 affected109 at risk
Teething	Gastrointestinal disorders		Non-systematic Assessment	EG00040 affected324 at risk EG00115 affected109 at risk
Pyrexia	General disorders		Non-systematic Assessment	EG00037 affected324 at risk EG00113 affected109 at risk
Rash	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG00024 affected324 at risk EG00117 affected109 at risk
Diarrhea	Gastrointestinal disorders		Non-systematic Assessment	EG00025 affected324 at risk EG0018 affected109 at risk
Vomiting	Gastrointestinal disorders		Non-systematic Assessment	EG00022 affected324 at risk EG0019 affected109 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG00017 affected324 at risk EG0013 affected109 at risk
Injection site reaction	General disorders		Non-systematic Assessment	EG0007 affected324 at risk EG00110 affected109 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0009 affected324 at risk EG0019 affected109 at risk
Irritability	General disorders		Non-systematic Assessment	EG0000 affected324 at risk EG0019 affected109 at risk
Pain	General disorders		Systematic Assessment	EG00091 affected324 at risk EG00142 affected109 at risk
Redness	General disorders		Systematic Assessment	EG000146 affected324 at risk EG00164 affected109 at risk
Swelling	General disorders		Systematic Assessment	EG00078 affected324 at risk EG00141 affected109 at risk
Drowsiness	General disorders		Systematic Assessment	EG000102 affected324 at risk EG00140 affected109 at risk
Fever (above or equal to 38 degrees Celsius)	General disorders		Systematic Assessment	EG00076 affected324 at risk EG00130 affected109 at risk
Irritability	General disorders		Systematic Assessment	EG000154 affected324 at risk EG00169 affected109 at risk
Loss of appetite	General disorders		Systematic Assessment	EG000102 affected324 at risk EG00140 affected109 at risk

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D014612	Vaccines
D022542	Measles-Mumps-Rubella Vaccine
C514867	Hiberix

ID	Term
D001688	Biological Products
D045424	Complex Mixtures
D017778	Vaccines, Combined
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D012411	Rubella Vaccine