Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Infections, Streptococcal Clinical Trial

Official title:

Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345358
• Other study ID #: 107058
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2006
• Est. completion date: November 15, 2007

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 15, 2007
• Est. primary completion date: November 15, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Weeks to 60 Months

Eligibility

Inclusion Criteria:

• Male or female between, and including

• 9-12 weeks of age at the time of first vaccination for the <6 Mo group.

• 7-11 months of age at the time of first vaccination for the 7-11 Mo group.

• 12-23 months of age at the time of first vaccination for the 12-23 Mo group.

• 24 months to 5 years at the time of first vaccination for the >= 24 Mo group.

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

• 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.

• Born after a gestation period between 36 and 42 weeks.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).

• Previous vaccination against S. pneumoniae.

• 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 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 since birth or planned administration during the entire study period.

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

Biological:
• Synflorix
1, 2, 3 or 4 Intramuscular injections, depending on age group
• Infanrix IPV/Hib
4 intramuscular injections

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kotka
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Vantaa
Finland	GSK Investigational Site	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Vesikari T, Karvonen A, Korhonen T, Karppa T, Sadeharju K, Fanic A, Dieussaert I, Schuerman L. Immunogenicity of 10-valent pneumococcal nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine when administered as catch-up vaccination to children 7 months to 5 years of age. Pediatr Infect Dis J. 2011 Aug;30(8):e130-41. doi: 10.1097/INF.0b013e31821d1790. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination)	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations = 0.05 microg/mL.	At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1
Secondary	Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)	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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations =0.05 µg/mL.	At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Secondary	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)	Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations = 0.05 µg/mL.	At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Secondary	Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)	OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Seropositivity = Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.	At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Secondary	Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)	OPA titers against pneumococcal serotypes 6A, 19A (Opsono-6A, 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.	At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Secondary	Antibody Concentrations Against Protein D (Anti-PD). (Primary/Full Vaccination)	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. Seropositivity = Anti-PD antibody concentrations >= 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.	At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Secondary	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination)	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations =0.05 µg/mL.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination)	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as Anti-pneumococcal serotypes antibody concentrations >=0.05 µg/mL.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination)	Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations = 0.05 µg/mL.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination)	OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination)	OPA titers against pneumococcal serotypes 6A, 19A (Opsono-6A, 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Antibody Concentrations Against Protein D. (Booster Vaccination)	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. Seropositivity = Anti-PD antibody concentrations >= 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.	Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Secondary	Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations. (Primary Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >=0.1 IU/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Secondary	Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Primary Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >=0.15 µg/mL and >= 1.0 µg/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group
Secondary	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >= 5 EL.U/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	At 1 month after the administration of the primary vaccination course(Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group
Secondary	Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination)	Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8.	At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Secondary	Booster Vaccine Response to PT, FHA and PRN	Booster vaccine response to PT, FHA and PRN, defined as appearance of antibodies in subjects who were seronegative (S-) prior to the booster dose (i.e., with concentrations < 5 EL.U/mL), and at least two-fold increase of pre-booster vaccination antibody concentrations in those who were seropositive (S+) prior to the booster dose (i.e., with concentrations >= 5 EL.U/ mL). Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	Before and one month after the booster dose with Synflorix™
Secondary	Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination)	Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the =24 months priming group.	Within 4-day (Days 0-3) following the primary vaccination
Secondary	Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination)	Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).	Within 4-day (Days 0-3) following the booster vaccination
Secondary	Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination)	Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [=] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.	Within 4 day (Days 0-3) following the booster vacination
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs). (Primary Vaccination)	An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.	Within 31-day (Days 0-30) post primary vaccination
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs). (Booster Vaccination)	An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.	Within 31 day (Days 0-30) following the booster vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs) (Primary Vaccination)	A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.	During the Primary vaccination course up until start of Booster vaccination course
Secondary	Number of Subjects With Serious Adverse Events (SAEs). (Booster Vaccination)	A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.	During the booster vaccination course
Secondary	Number of Subjects With Solicited General Symptoms (Primary Vaccination)	Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [=] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the =24 months priming group.	Within 4-day (Days 0-3) following the primary vaccination
Secondary	Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >= 0.1 IU/mL.. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Secondary	Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Booster Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >= 0.15 µg/mL and >= 1.0 µg/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Secondary	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination)	Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >=5 EL.U/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Secondary	Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination)	Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.	Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

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