Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496015

Enrollment

750

Registered

2007-07-04

Start date

2007-07-02

Completion date

2009-02-17

Last updated

2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Streptococcal

Keywords

Streptococcus Pneumoniae Vaccines, Meningococcal disease, Carriage, Prophylactic antipyretic, Safety, Pneumococcal vaccine, Fever, Pneumococcal disease, Immunogenicity, Meningococcal vaccine, Booster vaccination

Brief summary

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).

Detailed description

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

Interventions

BIOLOGICALInfanrix hexa.

1 intramuscular injection.

BIOLOGICALMeningococcal vaccine GSK134612.

1 intramuscular injection.

DRUGParacetamol.

Body weight of \< 7 kg: none; Body weight of ≥ 7 kg to \< 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.

BIOLOGICALPneumococcal conjugate vaccine GSK1024850A.

1 intramuscular injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 15 Months

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 12-15 months of age at the time of the vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. Subjects in the unprimed group • A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.

Exclusion criteria

For all subjects: * 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 * Indication, other than specified in the protocol, for prophylactic antipyretic treatment. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the 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 dose of study vaccines. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines. * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b 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 administration of the dose of study vaccines or planned administration during the study period. * Subjects of which both parents have a history of atopia. * Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination. * Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours. DTPa-HBV-IPV/Hib vaccine: * Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines. * Encephalopathy. * As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness. For subjects in the AP-AP, AP-NAP and NAP groups: • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017. For subjects in the AP-AP group: • Subject with any contraindication to treatment with paracetamol. For subjects in the unprimed group: * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y. * Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end. * Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry. * History of meningococcal disease due to serogroup A, C, W, or Y. * Administration of any pneumococcal vaccine since birth. * Full vaccination history since birth not available.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	Within 4 days (Day 0-3) after primary vaccine dose.	The cut-off for core fever was 38.0 degrees Celsius (ºC).

Secondary

Measure	Time frame	Description
Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	During the 4-day (Days 0-3) post-primary vaccination period	Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters (mm) from injection site.
Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	During the 4-day (Day 0-3) post-vaccination period	Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature \>40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reported With Unsolicited Adverse Events (AEs)	Within 31 days (Days 0-30) after primary vaccine dose.	The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reported With Serious Adverse Events (SAEs)	Throughout the entire study period (Month 0-Month 12)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.	Up to 6 months after vaccination with Mencevax™	Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.
Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination	Certain pneumococcal serotypes includes 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). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).
Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination	Certain pneumococcal serotypes included 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). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-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. The seropositivity cut-off for the assay was ≥ 8.
Concentrations of Antibodies Against Protein D (Anti-PD)	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination	The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).
Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination	Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination	OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination	The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.	Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination	Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.	Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).
Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	Within 4 days (Day 0-3) after primary vaccination dose	The cut-off value for core fever (rectal temperature) was 39.0ºC.
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group	Prior to vaccination (Pre)	The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	1 month post-vaccination (M1)	The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	1 month post-vaccination (M1)	The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	1 month post-vaccination (M1)	The seroprotection cut-off for the assay was ≥ 10 mIU/mL.
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	1 month post-vaccination (M1)	The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.
Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	1 month post-vaccination (M1)	The seroprotection cut-off for the assay was ≥ 8.
Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	12 month post-vaccination (M12)	The seroprotection cut-off for the assay was ≥ 8.
Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Number of Nasopharyngeal Swabs With H. Influenzae	Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)	Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.
Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group	Prior to vaccination (Pre)	The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Countries

Czechia

Participant flow

Recruitment details

This was a multicenter study with the same centers as the primary vaccination study 10PN-PD-DIT-010 (107017/NCT00370318) and all subjects enrolled in the primary vaccination study and having received Synflorix vaccine were invited to participate in the study. In addition, an age-matched pneumococcal vaccine unprimed control group has been enrolled.

Participants by arm

Arm	Count
Synflorix I Group Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.	178
Synflorix II Group Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment	27
Synflorix PRE Group Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.	172
Synflorix POST Group Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.	37
Mencevax + Infanrix Hexa Group Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.	336
Total	750

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
Overall Study	Other	1	0	0	1	0

Baseline characteristics

Characteristic	Synflorix I Group	Synflorix II Group	Synflorix PRE Group	Synflorix POST Group	Mencevax + Infanrix Hexa Group	Total
Age, Continuous	12.6 Months STANDARD_DEVIATION 0.77	13.2 Months STANDARD_DEVIATION 0.74	12.7 Months STANDARD_DEVIATION 0.77	13.1 Months STANDARD_DEVIATION 1.15	13.1 Months STANDARD_DEVIATION 1.1	12.6 Months STANDARD_DEVIATION 0.77
Race/Ethnicity, Customized Geographic ancestry Other - African + White-Caucasian	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African heritage	0 Participants	0 Participants	0 Participants	0 Participants	9 Participants	9 Participants
Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European heritage	177 Participants	27 Participants	172 Participants	37 Participants	327 Participants	740 Participants
Sex: Female, Male Female	90 Participants	11 Participants	79 Participants	18 Participants	155 Participants	353 Participants
Sex: Female, Male Male	88 Participants	16 Participants	93 Participants	19 Participants	181 Participants	397 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 178	0 / 27	0 / 172	0 / 37	0 / 336
other Total, other adverse events	153 / 178	23 / 27	154 / 172	35 / 37	290 / 336
serious Total, serious adverse events	13 / 178	5 / 27	13 / 172	4 / 37	30 / 336

Outcome results

Primary

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

The cut-off for core fever was 38.0 degrees Celsius (ºC).

Time frame: Within 4 days (Day 0-3) after primary vaccine dose.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	64 Participants
Synflorix II Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	14 Participants
Synflorix PRE Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	100 Participants
Synflorix POST Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	16 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off	146 Participants

95% CI: [11.78, 32.11]

Secondary

Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

Certain pneumococcal serotypes included 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). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Population: The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M12	0.42 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M12	0.46 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M12	0.67 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F PRE	0.74 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M1	2.86 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M1	2.9 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V PRE	0.61 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M12	0.68 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M12	1.46 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M1	1.67 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M1	6 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M12	0.26 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F PRE	0.98 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 PRE	0.4 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M12	0.56 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M1	3.01 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M12	0.34 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 PRE	0.36 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M1	1.99 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M1	4.96 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M1	2.3 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C PRE	0.47 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F PRE	0.38 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M12	0.89 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B PRE	0.35 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 PRE	0.22 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M1	4.58 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M1	1.35 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 PRE	0.82 μg/mL
Synflorix I Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M12	0.4 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M1	0.89 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M12	0.36 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M12	0.55 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M1	2.84 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M1	4.37 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F PRE	0.55 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M1	2.57 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M12	0.21 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M12	0.29 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M1	2.37 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M12	0.82 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V PRE	0.59 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M1	3.46 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M12	0.94 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M12	0.45 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 PRE	0.31 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 PRE	0.18 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M1	1.64 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M1	1.33 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M1	4.84 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 PRE	0.52 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B PRE	0.18 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M12	0.18 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M1	2 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F PRE	0.63 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F PRE	0.3 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C PRE	0.29 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 PRE	0.24 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M12	0.35 μg/mL
Synflorix II Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M12	0.44 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M1	7 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M1	4.21 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F PRE	1.05 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 PRE	0.31 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M1	2.62 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M12	0.39 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 PRE	0.6 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M12	0.5 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 PRE	0.59 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M1	3.68 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M12	0.72 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B PRE	0.55 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M1	2.45 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M12	0.56 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M1	4.13 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M12	0.91 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V PRE	1 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M1	4.39 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M12	0.97 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 PRE	1.57 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M1	5.95 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M12	1.54 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C PRE	0.78 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M12	1.05 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F PRE	1.48 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M1	7.55 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M12	1.8 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F PRE	0.54 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M1	2.92 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M12	0.8 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F PRE	0.45 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M12	0.86 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M1	2.25 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 PRE	1.27 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B PRE	0.5 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M1	5.86 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M12	0.58 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M12	1.25 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M1	3.03 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M12	0.98 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C PRE	0.54 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 PRE	0.53 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M12	0.55 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M1	3.95 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M1	6.13 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 PRE	0.45 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M1	3.86 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M12	0.92 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M12	0.41 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F PRE	1.4 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M1	2.97 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M1	8.77 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 PRE	0.26 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M12	2.04 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M12	0.96 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M1	4.38 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V PRE	0.99 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F PRE	0.87 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M1	4.35 μg/mL
Synflorix POST Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M12	0.54 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 PRE	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-23F M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M12	0.11 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-14 M1	0.05 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M12	0.06 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 PRE	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-5 M1	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-6B M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M1	0.05 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-1 PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-18C M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-4 PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-19F M12	0.12 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-9V M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.	ANTI-7F M12	0.04 μg/mL

Secondary

Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M1	0.4 μg/mL
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M12	0.22 μg/mL
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M12	0.14 μg/mL
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-PRE	0.15 μg/mL
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-PRE	0.12 μg/mL
Synflorix I Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M1	0.84 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M12	0.1 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M12	0.13 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M1	0.29 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-PRE	0.08 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-PRE	0.12 μg/mL
Synflorix II Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M1	0.56 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M1	0.86 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M12	0.24 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-PRE	0.21 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M12	0.36 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M1	1.34 μg/mL
Synflorix PRE Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-PRE	0.23 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M12	0.41 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-PRE	0.2 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M12	0.2 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-PRE	0.19 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M1	0.75 μg/mL
Synflorix POST Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M1	1.54 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M12	0.06 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M1	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-6A-M12	0.04 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-PRE	0.03 μg/mL
Mencevax + Infanrix Hexa Group	Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)	Anti-19A-M1	0.04 μg/mL

Secondary

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Time frame: 12 month post-vaccination (M12)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Arm	Measure	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	219.3 mIU/mL
Synflorix II Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	147.3 mIU/mL
Synflorix PRE Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	231.2 mIU/mL
Synflorix POST Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	139.2 mIU/mL
Mencevax + Infanrix Hexa Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	535.1 mIU/mL

Secondary

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Time frame: 1 month post-vaccination (M1)

Arm	Measure	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	1883.9 mIU/mL
Synflorix II Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	1460.6 mIU/mL
Synflorix PRE Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	2133 mIU/mL
Synflorix POST Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	1818.5 mIU/mL
Mencevax + Infanrix Hexa Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations	20610 mIU/mL

Secondary

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.

Time frame: Prior to vaccination (Pre)

Arm	Measure	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group	1336.1 mIU/mL

Secondary

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).

Time frame: 1 month post-vaccination (M1)

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PT, M1	83.3 EL.U/mL
Synflorix I Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PRN, M1	222.8 EL.U/mL
Synflorix I Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-FHA, M1	467.9 EL.U/mL
Synflorix II Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-FHA, M1	431.1 EL.U/mL
Synflorix II Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PT, M1	81.6 EL.U/mL
Synflorix II Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PRN, M1	153.4 EL.U/mL
Synflorix PRE Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-FHA, M1	453.8 EL.U/mL
Synflorix PRE Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PT, M1	82 EL.U/mL
Synflorix PRE Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PRN, M1	254.9 EL.U/mL
Synflorix POST Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PT, M1	76.7 EL.U/mL
Synflorix POST Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PRN, M1	220.4 EL.U/mL
Synflorix POST Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-FHA, M1	400.4 EL.U/mL
Mencevax + Infanrix Hexa Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-FHA, M1	580.8 EL.U/mL
Mencevax + Infanrix Hexa Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PT, M1	163.1 EL.U/mL
Mencevax + Infanrix Hexa Group	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Anti-PRN, M1	350.7 EL.U/mL

Secondary

Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8.

Time frame: 12 month post-vaccination (M12)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 3, M12	431.3 Titers
Synflorix I Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 2, M12	311.2 Titers
Synflorix I Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 1, M12	208.2 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 2, M12	212.4 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 1, M12	150.4 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 3, M12	301 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 3, M12	506.3 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 1, M12	234.5 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 2, M12	310.6 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 3, M12	672.2 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 1, M12	220.8 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 2, M12	400 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 2, M12	322.7 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 1, M12	335.4 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers	Anti-Polio 3, M12	203.3 Titers

Secondary

Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8.

Time frame: 1 month post-vaccination (M1)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 1, M1	1193 Titers
Synflorix I Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 2, M1	1354.1 Titers
Synflorix I Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 3, M1	2354.2 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 2, M1	2047.9 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 1, M1	1534.2 Titers
Synflorix II Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 3, M1	2233.3 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 3, M1	2647.5 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 2, M1	1413.2 Titers
Synflorix PRE Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 1, M1	1058.7 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 2, M1	2215.8 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 1, M1	1208.6 Titers
Synflorix POST Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 3, M1	3576.5 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 3, M1	8192 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 2, M1	8192 Titers
Mencevax + Infanrix Hexa Group	Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers	Anti-Polio 1, M1	4096 Titers

Secondary

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.

Time frame: 1 month post-vaccination (M1)

Arm	Measure	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	23.066 μg/mL
Synflorix II Group	Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	26.006 μg/mL
Synflorix PRE Group	Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	27.373 μg/mL
Synflorix POST Group	Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	22.011 μg/mL
Mencevax + Infanrix Hexa Group	Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	20.985 μg/mL

Secondary

Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Time frame: Prior to vaccination (Pre)

Arm	Measure	Value (GEOMETRIC_MEAN)
Synflorix I Group	Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group	0.512 IU/mL

Secondary

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Time frame: 1 month post-vaccination (M1)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-T, M1	7.382 IU/mL
Synflorix I Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-D, M1	10.112 IU/mL
Synflorix II Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-T, M1	8.684 IU/mL
Synflorix II Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-D, M1	9.839 IU/mL
Synflorix PRE Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-T, M1	9.583 IU/mL
Synflorix PRE Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-D, M1	12.285 IU/mL
Synflorix POST Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-T, M1	8.196 IU/mL
Synflorix POST Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-D, M1	11 IU/mL
Mencevax + Infanrix Hexa Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-T, M1	11.79 IU/mL
Mencevax + Infanrix Hexa Group	Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).	Anti-D, M1	7.291 IU/mL

Secondary

Concentrations of Antibodies Against Protein D (Anti-PD)

The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Population: The analyses were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-PRE	365.1 EL.U/mL
Synflorix I Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M12	468.1 EL.U/mL
Synflorix I Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M1	1654 EL.U/mL
Synflorix II Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M1	1813.5 EL.U/mL
Synflorix II Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-PRE	356.5 EL.U/mL
Synflorix II Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M12	418 EL.U/mL
Synflorix PRE Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M1	3134.2 EL.U/mL
Synflorix PRE Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-PRE	685.5 EL.U/mL
Synflorix PRE Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M12	834.6 EL.U/mL
Synflorix POST Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-PRE	584.3 EL.U/mL
Synflorix POST Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M12	713.4 EL.U/mL
Synflorix POST Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M1	2612.3 EL.U/mL
Mencevax + Infanrix Hexa Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M1	64.6 EL.U/mL
Mencevax + Infanrix Hexa Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-PRE	65.6 EL.U/mL
Mencevax + Infanrix Hexa Group	Concentrations of Antibodies Against Protein D (Anti-PD)	Anti-PD-M12	74.4 EL.U/mL

Secondary

Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSA, Pre	0.16 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSA, M1	36.28 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSA, M12	0.99 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSC, Pre	0.15 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSC, M1	14.12 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSC, M12	0.42 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSW-135, Pre	0.15 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSW-135, M1	6.11 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSW-135, M12	1.21 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSY, Pre	0.15 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSY, M1	8.03 μg/mL
Synflorix I Group	Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations	Anti-PSY, M12	1.81 μg/mL

Secondary

Number of Nasopharyngeal Swabs With H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	M12	57 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	Pre	41 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	M1	39 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	M3	34 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	M7	49 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With H. Influenzae	Overall	124 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	M7	64 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	M12	46 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	M3	62 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	Pre	48 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	Overall	160 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With H. Influenzae	M1	56 Swabs

Secondary

Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M1	20 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M7	22 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M12	22 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	Pre	19 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	Overall	61 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M3	17 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	Overall	86 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	Pre	21 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M1	30 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M3	31 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M12	19 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae	M7	28 Swabs

Secondary

Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M1	19 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M7	19 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M12	19 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M3	21 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	Overall	55 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	Pre	13 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	Overall	59 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	Pre	15 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M1	22 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M3	27 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M7	21 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)	M12	18 Swabs

Secondary

Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M3	32 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M1	30 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M7	29 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M12	22 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	Overall	82 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	Pre	26 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	Overall	111 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M3	45 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M7	42 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	Pre	27 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M12	39 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)	M1	42 Swabs

Secondary

Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (NUMBER)
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M7	42 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	Overall	111 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M3	49 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	Pre	43 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M12	34 Swabs
Synflorix I Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M1	45 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M12	43 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M3	55 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M7	50 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	M1	47 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	Overall	115 Swabs
Synflorix II Group	Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)	Pre	53 Swabs

Secondary

Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

Time frame: Up to 6 months after vaccination with Mencevax™

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.	Subject(s) with any rash(es)	7 Participants
Synflorix I Group	Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.	Subject(s) with any NOCI(s)	1 Participants
Synflorix I Group	Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.	Subject(s) with any ER visit(s)	0 Participants
Synflorix I Group	Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.	Subject(s) with any visit(s) at physician office	53 Participants

Secondary

Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters (mm) from injection site.

Time frame: During the 4-day (Days 0-3) post-primary vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Pain	2 Participants
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Swelling	2 Participants
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Redness	7 Participants
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Redness	89 Participants
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Pain	54 Participants
Synflorix I Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Swelling	52 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Swelling	1 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Redness	9 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Pain	10 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Redness	1 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Swelling	8 Participants
Synflorix II Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Pain	2 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Redness	74 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Redness	14 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Swelling	9 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Pain	79 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Pain	10 Participants
Synflorix PRE Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Swelling	50 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Pain	3 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Swelling	13 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Redness	1 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Pain	19 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Swelling	3 Participants
Synflorix POST Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Redness	12 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Redness	146 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Pain	4 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Redness	16 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Pain	114 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Grade 3 Swelling	12 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.	Any Swelling	71 Participants

Secondary

Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature \>40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.

Time frame: During the 4-day (Day 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	42 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	84 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	1 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	86 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	80 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Fever (rectal temperature > 40.0°C)	62 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (rectal temperature > 40.0°C)	1 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	91 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	47 Participants
Synflorix I Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (rectal temperature ≥ 38.0°C)	64 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	8 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (rectal temperature > 40.0°C)	0 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	11 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	11 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (rectal temperature ≥ 38.0°C)	14 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Fever (rectal temperature > 40.0°C)	14 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	17 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	0 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	17 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
Synflorix II Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	7 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	98 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	79 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	41 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	105 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (rectal temperature ≥ 38.0°C)	100 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	2 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (rectal temperature > 40.0°C)	1 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	46 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	4 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Fever (rectal temperature > 40.0°C)	99 Participants
Synflorix PRE Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	84 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	18 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (rectal temperature ≥ 38.0°C)	16 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Fever (rectal temperature > 40.0°C)	16 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	2 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	19 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	18 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (rectal temperature > 40.0°C)	0 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	10 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	10 Participants
Synflorix POST Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	18 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	146 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	129 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	120 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	88 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (rectal temperature > 40.0°C)	3 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (rectal temperature ≥ 38.0°C)	146 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	147 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	71 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	2 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	3 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Related Fever (rectal temperature > 40.0°C)	140 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	2 Participants

Secondary

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

The cut-off value for core fever (rectal temperature) was 39.0ºC.

Time frame: Within 4 days (Day 0-3) after primary vaccination dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	4 Participants
Synflorix II Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	0 Participants
Synflorix PRE Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	14 Participants
Synflorix POST Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	1 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off	16 Participants

Secondary

Number of Subjects Reported With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: Throughout the entire study period (Month 0-Month 12)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Serious Adverse Events (SAEs)	13 Participants
Synflorix II Group	Number of Subjects Reported With Serious Adverse Events (SAEs)	5 Participants
Synflorix PRE Group	Number of Subjects Reported With Serious Adverse Events (SAEs)	13 Participants
Synflorix POST Group	Number of Subjects Reported With Serious Adverse Events (SAEs)	4 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects Reported With Serious Adverse Events (SAEs)	30 Participants

Secondary

Number of Subjects Reported With Unsolicited Adverse Events (AEs)

The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within 31 days (Days 0-30) after primary vaccine dose.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects Reported With Unsolicited Adverse Events (AEs)	22 Participants
Synflorix II Group	Number of Subjects Reported With Unsolicited Adverse Events (AEs)	3 Participants
Synflorix PRE Group	Number of Subjects Reported With Unsolicited Adverse Events (AEs)	64 Participants
Synflorix POST Group	Number of Subjects Reported With Unsolicited Adverse Events (AEs)	30 Participants

Secondary

Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

Certain pneumococcal serotypes includes 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). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Population: The analysis were performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M1	140 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M12	129 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V PRE	117 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M1	134 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M12	132 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M12	97 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F PRE	130 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B PRE	110 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M1	141 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M12	115 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M12	135 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 PRE	74 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M1	138 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M1	140 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M12	113 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F PRE	128 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M12	113 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M12	89 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 PRE	123 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C PRE	118 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M12	131 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M1	141 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M1	135 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M1	140 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M12	103 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 PRE	131 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 PRE	102 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M1	140 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F PRE	103 Participants
Synflorix I Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M1	141 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M1	24 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B PRE	13 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F PRE	14 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V PRE	20 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M12	20 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M12	11 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M12	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M1	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M1	25 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M12	18 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M1	23 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C PRE	14 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F PRE	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M1	25 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M12	14 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M12	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 PRE	15 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M12	18 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M12	22 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M12	16 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 PRE	22 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M1	25 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M1	24 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 PRE	14 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M1	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M12	18 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F PRE	21 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M1	24 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M1	24 Participants
Synflorix II Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 PRE	15 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C PRE	154 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M1	166 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F PRE	156 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M12	166 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M1	163 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 PRE	115 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M12	122 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 PRE	147 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 PRE	142 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M12	159 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B PRE	143 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M12	148 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M12	165 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V PRE	152 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 PRE	159 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M1	166 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M12	166 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M12	147 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M1	167 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M12	157 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F PRE	163 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M1	165 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M12	165 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F PRE	132 Participants
Synflorix PRE Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M12	154 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M1	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M12	27 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M12	35 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 PRE	30 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M1	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F PRE	30 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M1	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F PRE	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 PRE	27 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M12	34 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 PRE	35 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M1	37 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 PRE	31 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M12	33 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M12	35 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M1	37 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F PRE	34 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M1	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M1	37 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C PRE	29 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M1	37 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M1	35 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M12	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M12	30 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M12	30 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B PRE	32 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M1	37 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V PRE	34 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M12	36 Participants
Synflorix POST Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M12	30 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M12	31 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M1	10 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V M12	30 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M12	20 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M12	21 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 PRE	25 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 M1	6 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 PRE	6 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M1	29 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-4 PRE	6 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-14 M12	63 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M12	11 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F PRE	2 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C PRE	8 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M1	9 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 M1	5 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-5 M1	10 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-18C M12	29 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-1 PRE	6 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M12	24 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-23F M1	4 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M1	24 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F PRE	17 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F PRE	5 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M1	9 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B M1	1 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-7F M12	20 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-6B PRE	1 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-19F M12	90 Participants
Mencevax + Infanrix Hexa Group	Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off	ANTI-9V PRE	5 Participants

Secondary

Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA M1 ≥ 2.0 μg/mL	271 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA M12 ≥ 0.3 μg/mL	133 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA M12 ≥ 2.0 μg/mL	47 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC PRE ≥ 0.3 μg/mL	3 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 M1 ≥ 0.3 μg/mL	258 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA PRE ≥ 0.3 μg/mL	12 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA PRE ≥ 2.0 μg/mL	1 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSA M1≥ 0.3 μg/mL	271 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC PRE ≥ 2.0 μg/mL	0 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC M1 ≥ 0.3 μg/mL	278 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC M1≥ 2.0 μg/mL	277 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC M12 ≥ 0.3 μg/mL	94 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSC M12 ≥ 2.0 μg/mL	9 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 PRE ≥ 0.3 μg/mL	1 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 PRE ≥ 2.0 μg/mL	0 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 M1 ≥ 2.0 μg/mL	234 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 M12 ≥ 0.3 μg/mL	117 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSW-135 M12 ≥ 2.0 μg/mL	45 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY PRE ≥ 0.3 μg/mL	3 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY PRE ≥ 2.0 μg/mL	0 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY M1 ≥ 0.3 μg/mL	261 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY M1 ≥ 2.0 μg/mL	249 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY M12 ≥ 0.3 μg/mL	131 Participants
Synflorix I Group	Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values	ANTI-PSY M12 ≥ 2.0 μg/mL	59 Participants

Secondary

Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M3	22 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M12	39 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M7	37 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	Overall	104 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M1	21 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	Overall	129 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M1	32 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M3	40 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M7	42 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.	M12	35 Participants

Secondary

Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M3	63 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M12	65 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M1	43 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M7	70 Participants
Synflorix I Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	Overall	161 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	Overall	195 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M3	76 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M7	73 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M12	70 Participants
Synflorix II Group	Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs	M1	56 Participants

Secondary

Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Time frame: Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC, Pre, ≥ 1:128	17 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC, M1, ≥ 1:128	294 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135, M1, ≥ 1:128	301 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA,Pre, ≥ 1:8	69 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA, Pre, ≥ 1:128	44 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA, M1, ≥ 1:8	298 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA, M1, ≥ 1:128	298 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA, M12, ≥ 1:8	136 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenA, M12, ≥ 1:128	134 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC,Pre, ≥ 1:8	50 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC, M1, ≥ 1:8	300 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC, M12, ≥ 1:8	154 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenC, M12, ≥ 1:128	105 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135,Pre, ≥ 1:8	114 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135, Pre, ≥ 1:128	59 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135, M1, ≥ 1:8	301 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135, M12, ≥ 1:8	138 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenW-135, M12, ≥ 1:128	129 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY,Pre, ≥ 1:8	167 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY, Pre, ≥ 1:128	93 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY, M1, ≥ 1:8	300 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY, M1, ≥ 1:128	300 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY, M12, ≥ 1:8	137 Participants
Synflorix I Group	Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values	rSBA-MenY, M12, ≥ 1:128	127 Participants

Secondary

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M1	39.2 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-PRE	72.4 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-PRE	5 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M12	59.4 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M12	7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M1	251.5 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-PRE	4.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M1	105.1 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M1	39.7 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M12	4.8 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-PRE	35.6 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M12	23 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M1	401.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-PRE	4.8 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M12	52.1 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-PRE	65.4 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M1	89.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M12	8.9 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M12	37.2 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-PRE	66 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M1	403.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-PRE	5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M1	99.6 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M12	9.5 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M12	4.7 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-M1	4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M1	16.1 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-PRE	9.7 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-19A-PRE	4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A	OPSONO-6A-M12	17.1 Titers

Secondary

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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. The seropositivity cut-off for the assay was ≥ 8.

Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M12	1503.3 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C PRE	6.1 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V PRE	420.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M12	12.8 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M12	434.5 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M1	2234.8 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M12	19.9 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M12	791.6 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 PRE	189.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M1	1581.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M1	144.6 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 PRE	8.5 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 PRE	6.1 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M1	134.3 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M12	386.4 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M12	10.3 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M1	2335.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B PRE	32.5 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F PRE	288.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M12	64.3 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M1	496.7 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 PRE	23.8 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M1	629.4 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M12	46.9 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M1	1547.9 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F PRE	21.2 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F PRE	413.6 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M12	11.9 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M1	4025.8 Titers
Synflorix I Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M1	652.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M12	97.7 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M12	12.5 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M12	10.5 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M12	438.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M12	39.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V PRE	472.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C PRE	6 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F PRE	310.1 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M1	1749 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M1	752.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B PRE	15.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M1	1515 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 PRE	150.2 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 PRE	8.8 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M12	552.2 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M12	14.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M12	24.7 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M1	193.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F PRE	221.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 PRE	5.6 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M1	971.6 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 PRE	10.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M1	148.3 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M12	1606.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M12	433.8 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F PRE	17.4 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M1	105 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M1	372.9 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M1	269.7 Titers
Synflorix II Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M1	1223.1 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 PRE	44.9 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M1	417 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M12	27.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M1	2297 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M12	51.2 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 PRE	16.6 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M1	289.3 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M12	23.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B PRE	45.2 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M1	985.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M12	53.9 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F PRE	584.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M1	4674.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M12	1285.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V PRE	407.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M1	2403.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M12	906.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 PRE	293.2 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M1	1865.2 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M12	447.5 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C PRE	11.7 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M1	737.8 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F PRE	35.1 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M1	1062.2 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M12	101.3 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F PRE	408 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M1	3154 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M12	857.5 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 PRE	8.1 Titers
Synflorix PRE Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M12	23.1 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M12	23.5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M12	1738.3 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M1	325 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C PRE	9.5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M1	2212.2 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M1	537.6 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F PRE	258.4 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M12	558 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M12	29.4 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F PRE	36.4 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M1	718.3 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M1	1303.2 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M1	1198.8 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M12	121.3 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B PRE	49.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M12	20.5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F PRE	305.3 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M12	15.4 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M1	1808.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M1	227.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M12	670.2 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 PRE	15.1 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 PRE	29.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M12	716.8 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 PRE	6 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 PRE	227.4 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M1	1155.5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M1	1964.5 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V PRE	365.7 Titers
Synflorix POST Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M12	72.5 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M12	4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M12	287.8 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M12	6.8 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M1	267.3 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 PRE	11.5 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F PRE	20.2 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C PRE	4.5 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M12	127.2 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F PRE	90 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M1	5.1 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 M1	4.3 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M1	4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 M12	4.7 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M12	19.1 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-14 M1	158 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-18C M12	4.6 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M1	261.8 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B M1	20.9 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 M1	7.8 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V M1	87.4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F PRE	5.3 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-5 PRE	4.2 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-4 PRE	5.9 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-1 PRE	4.9 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M1	4.5 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-6B PRE	9.9 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-9V PRE	69.2 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-23F M12	147.1 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-19F M12	6.4 Titers
Mencevax + Infanrix Hexa Group	Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F	OPSONO-7F M12	681.1 Titers

Secondary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group

Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenA, M1	2151.3 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenW-135,Pre	16.3 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenW-135, M1	5393.6 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenY, M12	665.2 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenA,Pre	11.5 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenA, M12	677.6 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenC,Pre	6.9 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenC, M1	811.2 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenC, M12	191.1 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenW-135, M12	573.1 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenY,Pre	30.2 Titers
Synflorix I Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group	rSBA-MenY, M1	2863.7 Titers

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

Concentrations of Antibodies Against Protein D (Anti-PD)

Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

Number of Nasopharyngeal Swabs With H. Influenzae

Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

Number of Subjects Reported With Serious Adverse Events (SAEs)

Number of Subjects Reported With Unsolicited Adverse Events (AEs)

Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group