Pneumococcal Vaccine Booster Study in Healthy Children 11... | NCT00463437

NCT00463437

ID	Type	Description	Link
2006-005733-38	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Experimental	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Infanrix hexa Biological: Infanrix IPV Hib Biological: Meningitec
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Experimental	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Infanrix hexa Biological: Infanrix IPV Hib Biological: NeisVac-C
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Experimental	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Infanrix penta Biological: Infanrix IPV Biological: Menitorix
Prevenar™ + Menitorix™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal conjugate vaccine GSK1024850A	Biological	Intramuscular injection, 1 dose.	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)	Fever was measured as rectal temperature.	During the 4-day (Day 0-3) period after the booster vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling.	During the 4-day (Day 0-3) period after the booster vaccination
Number of Subjects Reporting Solicited General Symptoms

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine.
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.

Exclusion Criteria:

Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines).
Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005.
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Acute disease at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bad Saulgau	Baden-Wurttemberg	88348	Germany
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19325447	Background	Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.
19325452

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
109507	Study Protocol	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
BG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
BG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
BG003	Prevenar™ + Menitorix™	Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
BG004	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 Reporting Fever Above 39.0 Degree Celsius (°C)

Fever was measured as rectal temperature.

Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.

Posted

Number

subjects

During the 4-day (Day 0-3) period after the booster vaccination

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
OG003	Prevenar™ + Menitorix™	Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Units	Counts
Participants	OG0000 OG0010 OG002355 OG003

Title

Denominators

Categories

Title	Measurements
	OG00211 OG0038

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Subjects from the Total Vaccinated cohort for whom data were available.

Posted

Number

subjects

During the 4-day (Day 0-3) period after the booster vaccination

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Secondary

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.

Subjects from the Total Vaccinated cohort for whom data were available.

Posted

Number

subjects

During the 4-day (Day 0-3) period after the booster vaccination

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AE)

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.

Posted

Number

subjects

During the 31-day (Day 0-30) period after the booster vaccination

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Secondary

Number of Subjects Reporting Serious Adverse Events (SAE)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Posted

Number

subjects

During the 31-day (Day 0-30) period after the booster vaccination

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects Reporting Serious Adverse Events (SAE)

Posted

Number

subjects

From the beginning of the study up to the end of the extended 6-month safety follow-up period

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8.

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value

Anti-pneumococcal antibody cut-off value assessed was ≥ 8.

The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value

Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

Secondary

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value

Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Secondary

Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value

Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Secondary

Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value

Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

Before (pre) and one month after (post) the booster administration

ID	Title	Description
OG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
OG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
OG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.	15	297	359
EG001	GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.	9	303	363
EG002	GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.	13	302	358
EG003	Prevenar™ + Menitorix™	Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.	13	287	357

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0002 affected359 at risk EG0014 affected363 at risk EG0022 affected358 at risk EG0033 affected357 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0002 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003
Febrile convulsion	Nervous system disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0011 affected363 at risk EG0022 affected358 at risk EG003
Gastroenteritis rotavirus	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Bronchopneumonia	Infections and infestations	Non-systematic Assessment	EG0001 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0001 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0011 affected363 at risk EG0022 affected358 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003
Acute tonsillitis	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Bronchpneumopathy	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Breath holding	Psychiatric disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Concussion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Electric shock	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Epilepsy	Nervous system disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Laryngitis	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Pyelonephritis acute	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0010 affected363 at risk EG0021 affected358 at risk EG003
Salmonellosis	Infections and infestations	Non-systematic Assessment	EG0001 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Tracheitis	Infections and infestations	Non-systematic Assessment	EG0001 affected359 at risk EG0010 affected363 at risk EG0020 affected358 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003
Viral infection	Infections and infestations	Non-systematic Assessment	EG0000 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected359 at risk EG0011 affected363 at risk EG0020 affected358 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0006 affected359 at risk EG00119 affected363 at risk EG00214 affected358 at risk EG00318 affected357 at risk
Pain	General disorders	Systematic Assessment	EG000196 affected359 at risk EG001195 affected363 at risk EG002193 affected358 at risk EG003
Redness	General disorders	Systematic Assessment	EG000194 affected359 at risk EG001183 affected363 at risk EG002186 affected358 at risk EG003
Swelling	General disorders	Systematic Assessment	EG000162 affected359 at risk EG001148 affected363 at risk EG002150 affected358 at risk EG003
Drowsiness	General disorders	Systematic Assessment	EG000124 affected359 at risk EG001142 affected363 at risk EG002139 affected358 at risk EG003
Fever	General disorders	Systematic Assessment	EG000109 affected359 at risk EG001122 affected363 at risk EG002105 affected358 at risk EG003
Irritability	General disorders	Systematic Assessment	EG000170 affected359 at risk EG001190 affected363 at risk EG002191 affected358 at risk EG003
Loss of appetite	General disorders	Systematic Assessment	EG000101 affected359 at risk EG00199 affected363 at risk EG002112 affected358 at risk EG003

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D009187	Myelitis
D002494	Central Nervous System Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013118	Spinal Cord Diseases
D000090862	Neuroinflammatory Diseases
D009468	Neuromuscular Diseases
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D013290	Streptococcal Infections

ID	Term
D006509	Hepatitis B
D013742	Tetanus
D011051	Poliomyelitis
D004165	Diphtheria
D005334	Fever
D008589	Meningococcal Infections
D011008	Pneumococcal Infections

ID	Term
D000069443	Heptavalent Pneumococcal Conjugate Vaccine
D022242	Pneumococcal Vaccines
C541235	diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
C410218	serogroup C meningococcal conjugate vaccine

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D017778	Vaccines, Combined