Primary and Booster Vaccination Study With Pneumococcal V... | NCT01027845

NCT01027845

ID	Type	Description	Link
2011-003710-16	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10Pn Group	Experimental	Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.	Biological: Pneumococcal vaccine GSK1024850A Biological: DTPa
DTPa Group	Active Comparator	Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.	Biological: DTPa

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal vaccine GSK1024850A	Biological	Intramuscular injection, 4 doses	10Pn Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)	Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).	1 month following primary immunization (at Month 3)

Secondary Outcomes

Measure	Description	Time Frame
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)	Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
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).
Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of, or intercurrent diphtheria, tetanus, pertussis disease.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
Major congenital defects or serious chronic illness.
History of any seizures or progressive neurological disease.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Child in care.
Acute disease and/or fever at the time of enrolment.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Aichi		451-0052	Japan
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25830489	Background	Iwata S, Kawamura N, Kuroki H, Tokoeda Y, Miyazu M, Iwai A, Oishi T, Sato T, Suyama A, Francois N, Shafi F, Ruiz-Guinazu J, Borys D. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study. Hum Vaccin Immunother. 2015;11(4):826-37. doi: 10.1080/21645515.2015.1012019.

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
112640	Study Protocol	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

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

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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

FG000237 subjects
FG001123 subjects
FG0020 subjectsSubjects were not yet assigned to this group at the time of the primary vaccination
FG0030 subjectsSubjects were not yet assigned to this group at the time of the primary vaccination

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
BG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..
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

- ParticipantsOG000231
- ParticipantsOG001119

Title	Measurements
	OG0006.52(5.85 to 7.26)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group. At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1.					GMC ratio	0.16			2-Sided	95	0.14	0.18					Non-Inferiority	Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).

Secondary

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

Secondary

Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)

Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Posted

Geometric Mean

95% Confidence Interval

Titers

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

Secondary

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)

Posted

Geometric Mean

95% Confidence Interval

μg/mL

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group

Secondary

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)

Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

Secondary

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)

Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.

Posted

Geometric Mean

95% Confidence Interval

Titers

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).

Secondary

Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)

Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against Protein D before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Booster Group

Secondary

Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)

Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.

The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Diphtheria Toxoid or Tetanus Toxoid after primary vaccination.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)

Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against DT or TT before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Booster Group	Subjects from DTPa + Prevenar Group and DTPa - no Prevenar Group.

Secondary

Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)

Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL

The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Pertussis or Filamentous haemagglutinin after primary vaccination.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

1 month following primary immunization (at Month 3)

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)

Analysis was performed on the ATPcohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against PT or FHA before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e. subjects with or without Prevenar vaccination

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Booster Group

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.

The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) after each primary vaccine dose

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination

The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Posted

Number

Subjects

During the 8-day (Days 0-7) period following booster vaccination

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Booster Group	Subjects from DTPa + Prevenar Group and DTPa - no Prevenar Group.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination

General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) after each primary vaccine dose

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination

Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.

Posted

Number

Subjects

During the 8-day (Days 0-7) period following booster vaccination

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001

Secondary

Number of Subjects With Unsolicited AEs After Primary Vaccination

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.

Posted

Number

Subjects

Within the 31-day (Days 0-30) post-primary vaccination period, across doses

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Secondary

Number of Subjects With Unsolicited AEs After Booster Vaccination

The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.

Posted

Number

Subjects

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

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Booster Group	Subjects from DTPa + Prevenar Group and DTPa - no Prevenar Group.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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

The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.

Posted

Count of Participants

Participants

From study start at Month 0 up to study end at Month 15-17

ID	Title	Description
OG000	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).
OG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

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	10Pn Group	Healthy male or female subjects, between 90 and 118 days of age who received, during primary vaccination phase, 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase).	1	237	28	237	236	237
EG001	DTPa Group	Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..	0	123	19	123	122	123

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear malformation	Congenital, familial and genetic disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Faciodigitogenital dysplasia	Congenital, familial and genetic disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Strabismus	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Intussusception	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Sudden infant death syndrome	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Food allergy	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Acute tonsillitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 events3 affected237 at risk EG0013 events3 affected123 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected123 at risk
Croup infectious	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0013 events3 affected123 at risk
Exanthema subitum	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 events3 affected237 at risk EG0010 events0 affected123 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0011 events1 affected123 at risk
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Laryngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0012 events1 affected123 at risk
Meningitis staphylococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Otitis media	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected123 at risk
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected123 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0007 events6 affected237 at risk EG0011 events1 affected123 at risk
Pneumonia adenoviral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected123 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected237 at risk EG0011 events1 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected123 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0012 events2 affected123 at risk
Viral pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events1 affected237 at risk EG0010 events0 affected123 at risk
Febrile convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected123 at risk
Myelitis transverse	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0011 events1 affected123 at risk
Fibrinous bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk
Tuberculid	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected123 at risk
Kawasaki's disease	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected123 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00021 events17 affected237 at risk EG00118 events15 affected123 at risk
Conjunctivitis	Eye disorders	MedDRA 17.0	Systematic Assessment	EG00022 events18 affected237 at risk EG00113 events9 affected123 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG000133 events91 affected237 at risk EG00143 events37 affected123 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG00019 events15 affected237 at risk EG0019 events9 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00032 events29 affected237 at risk EG00114 events14 affected123 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG00065 events49 affected237 at risk EG00128 events25 affected123 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG000768 events230 affected237 at risk EG001368 events114 affected123 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00019 events18 affected237 at risk EG0015 events5 affected123 at risk
Impetigo	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected237 at risk EG0019 events8 affected123 at risk
Injection site induration	General disorders	MedDRA 17.0	Systematic Assessment	EG00086 events56 affected237 at risk EG00134 events23 affected123 at risk
Irritability	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG000358 events177 affected237 at risk EG001154 events81 affected123 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00060 events41 affected237 at risk EG00141 events24 affected123 at risk
Otitis media	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00010 events9 affected237 at risk EG0017 events7 affected123 at risk
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG000354 events167 affected237 at risk EG001115 events62 affected123 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG000284 events156 affected237 at risk EG00192 events64 affected123 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00016 events14 affected237 at risk EG0014 events4 affected123 at risk
Somnolence	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG000244 events131 affected237 at risk EG001113 events63 affected123 at risk
Swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG000610 events214 affected237 at risk EG001265 events113 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG000131 events85 affected237 at risk EG00169 events43 affected123 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00020 events19 affected237 at risk EG0019 events7 affected123 at risk

ID	Term
D013290	Streptococcal Infections
D011008	Pneumococcal Infections

ID	Term
C547294	PHiD-CV vaccine
D004369	Pentetic Acid

OG0010.04(0.03 to 0.04)

Healthy male or female subjects, between 90 and 118 days of age, who received, during the primary vaccination phase, 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age (booster vaccination phase). Subjects from this group who also received at least one dose of Prevenar (PCV7): Pfizer's (formerly Wyeth Lederle) 7-valent pneumococcal conjugate vaccine, given before pre-booster blood sample (as optional treatment considered as standard of care), were assigned to the DTPa + Prevenar Group in the booster phase, and subjects who did not receive any dose of Prevenar before pre-booster blood sample were assigned to the DTPa-no Prevenar Group in the booster phase. Some booster phase analyses were only performed on subjects of both pooled sub-groups, renamed as DTPa booster Group, at the time of the analysis..

Subjects from DTPa + Prevenar Group and DTPa - no Prevenar Group.

OG0010.04(0.04 to 0.05)

OG0020.24(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0010.85(0.71 to 1.02)

OG0020.03(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0010.78(0.64 to 0.94)

OG0010.08(0.07 to 0.1)

OG0020.05(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0010.15(0.12 to 0.17)

OG0010.34(0.27 to 0.44)

OG0010.33(0.25 to 0.42)

OG0010.05(0.04 to 0.05)

OG0010.09(0.08 to 0.11)

OG0011.01(0.83 to 1.25)

OG0010.96(0.79 to 1.17)

OG0013.17(2.74 to 3.67)

OG0020.09(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0012.92(2.53 to 3.38)

OG0020.16(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0010.94(0.79 to 1.11)

OG0010.77(0.65 to 0.92)

OG0010.51(0.38 to 0.68)

OG0010.68(0.51 to 0.91)

OG0010.55(0.42 to 0.73)

OG0010.88(0.7 to 1.12)

OG0014.7(4.1 to 5.5)

OG0024(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG00179(49.3 to 126.7)

OG002371(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG00169.3(43.1 to 111.5)

OG002493(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0014.2(3.9 to 4.5)

OG0014.7(4.1 to 5.3)

OG001118.5(66.3 to 211.7)

OG001119(68.5 to 206.9)

OG0011014.7(743.8 to 1384.1)

OG002588(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

(12109.3 to 16521.4)

OG0011165.6(855.7 to 1587.8)

OG0021278(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0011081.6(803.3 to 1456.4)

OG0024595(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG001958.8(680 to 1351.8)

OG002367(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG001826.7(669.3 to 1021)

OG001819.1(651.4 to 1030.1)

OG00111.5(8.2 to 16)

OG00112.7(9.1 to 17.7)

OG00121.1(13.5 to 32.9)

OG00120.9(13.7 to 31.8)

OG002191(NA to NA)The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable because number of subjects with concentrations within the specified range = 0)

OG0011048(561.5 to 1956.1)

OG0011758.3(949.4 to 3256.5)

OG0010.21(0.16 to 0.27)

OG0010.12(0.09 to 0.16)

OG0010.15(0.11 to 0.2)

OG001103.3(60.4 to 176.6)

OG0017.7(5.5 to 10.6)

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

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids