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Clinical Trial Results:
A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell disease between 8 weeks and 2 years of age, as compared to healthy children.

Summary
EudraCT number	2012-000254-64
Trial protocol	Outside EU/EEA
Global end of trial date	23 May 2013

Results information
Results version number	v3(current)
This version publication date	31 Mar 2023
First version publication date	25 Jul 2015
Other versions	v1 , v2
Version creation reason	Correction of full data set Correction of full data set and alignment between registries.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

114056

ISRCTN number

US NCT number

NCT01175083

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000673-PIP01-09

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

04 Aug 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 May 2013

Was the trial ended prematurely?

Main objective of the trial

To assess the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPw-HBV/Hib and OPV vaccines in children with sickle cell disease, one month after completion of the 3-dose primary vaccination course before 6 months of age

Protection of trial subjects

All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jun 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Burkina Faso: 300

Worldwide total number of subjects

300

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

300

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Period 1 title

Primary Epoch

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Arm description

Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Investigational medicinal product name

Tritanrix-HB

Investigational medicinal product code

Other name

DTPw-HBV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, 4 doses in the left thigh.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

4 doses administered orally.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

White frozen dried pellet in monodose vial to be reconstituted with DTPw-HBV vaccine, intramuscular injection 4 doses in the left thigh.

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Arm description

Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

Arm type

Active comparator

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Investigational medicinal product name

Tritanrix-HB

Investigational medicinal product code

Other name

DTPw-HB

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, 4 doses in the left thigh.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

4 doses administered orally.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

White frozen dried pellet in monodose vial to be reconstituted with DTPw-HBV vaccine, intramuscular injection 4 doses in the left thigh.

Synflorix 7-11S Group

Arm description

Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Synflorix 7-11NS Group

Arm description

Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

Arm type

Active comparator

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Synflorix 12-23S Group

Arm description

Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Synflorix 12-23NS Group

Arm description

Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Arm type

Active comparator

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Number of subjects in period 1	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Started	50	50	50	50	50	50
Completed	50	50	50	50	50	47
Not completed	0	0	0	0	0	3
Consent withdrawn by subject	-	-	-	-	-	2
Lost to follow-up	-	-	-	-	-	1

Period 2 title

Booster Epoch

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Investigational medicinal product name

Tritanrix-HB

Investigational medicinal product code

Other name

DTPw-HBV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, 4 doses in the left thigh.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

4 doses administered orally.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

White frozen dried pellet in monodose vial to be reconstituted with DTPw-HBV vaccine, intramuscular injection 4 doses in the left thigh.

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Investigational medicinal product name

Tritanrix-HB

Investigational medicinal product code

Other name

DTPw-HBV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, 4 doses in the left thigh.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

4 doses administered orally.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

White frozen dried pellet in monodose vial to be reconstituted with DTPw-HBV vaccine, intramuscular injection 4 doses in the left thigh.

Synflorix 7-11S Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Synflorix 7-11NS Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

GSK1024850A (Synflorix)

Investigational medicinal product code

Other name

GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

Number of subjects in period 2 ^[1]	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group
Started	49	49	50	50
Completed	49	49	49	49
Not completed	0	0	1	1
Consent withdrawn by subject	-	-	-	1
Death	-	-	1	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: One subject died between both Epochs and hence did not participate in the Booster Epoch.

Baseline characteristics

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Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Reporting group description

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Reporting group description

Reporting group title

Synflorix 7-11S Group

Reporting group description

Reporting group title

Synflorix 7-11NS Group

Reporting group description

Reporting group title

Synflorix 12-23S Group

Reporting group description

Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Reporting group title

Synflorix 12-23NS Group

Reporting group description

Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Reporting group values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group	Total
Number of subjects	50	50	50	50	50	50	300
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	50	50	50	50	50	50	300
Children (2-11 years)	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0
Adults (18-64 years)	0	0	0	0	0	0	0
From 65-84 years	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0
Gender categorical
Units: Subjects
Female	21	29	26	32	15	24	147
Male	29	21	24	18	35	26	153

End points

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Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Reporting group description

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Reporting group description

Reporting group title

Synflorix 7-11S Group

Reporting group description

Reporting group title

Synflorix 7-11NS Group

Reporting group description

Reporting group title

Synflorix 12-23S Group

Reporting group description

Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Reporting group title

Synflorix 12-23NS Group

Reporting group description

Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Reporting group description

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Reporting group description

Reporting group title

Synflorix 7-11S Group

Reporting group description

Reporting group title

Synflorix 7-11NS Group

Reporting group description

Primary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

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End point title

Concentrations of antibodies against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines ^[1] ^[2]

End point description

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

End point type

Primary

End point timeframe

One month after primary vaccination (Month 3)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	48	46
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-1 [Month 3] (N=48,46)	3.51 (2.77 to 4.44)	3.63 (2.91 to 4.53)
Anti-4 [Month 3] (N=47,46)	4.25 (3.18 to 5.67)	3.51 (2.73 to 4.51)
Anti-5 [Month 3] (N=47,46)	5.15 (4.07 to 6.51)	5.94 (4.91 to 7.18)
Anti-6B [Month 3] (N=48,46)	1.29 (0.83 to 1.99)	1.13 (0.74 to 1.72)
Anti-7F [Month 3] (N=48,46)	4.91 (3.84 to 6.28)	4.28 (3.49 to 5.26)
Anti-9V [Month 3] (N=47,46)	4.56 (3.51 to 5.92)	4.59 (3.7 to 5.7)
Anti-14 [Month 3] (N=46,46)	4.3 (3.08 to 6)	5.95 (4.27 to 8.29)
Anti-18C [Month 3] (N=47,45)	14.6 (11.01 to 19.36)	11.33 (8.47 to 15.17)
Anti-19F [Month 3] (N=47,46)	11.87 (9.05 to 15.57)	9.78 (7.01 to 13.64)
Anti-23F [Month 3] (N=48,46)	1.32 (0.9 to 1.93)	1.41 (0.95 to 2.11)

No statistical analyses for this end point

Primary: Concentrations of antibodies against protein D (PD) for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

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End point title

Concentrations of antibodies against protein D (PD) for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines ^[3] ^[4]

End point description

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

End point type

Primary

End point timeframe

One month after the primary vaccination (Month 3)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	47	46
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PD [Month 3] (N=47,46)	2789.09 (2313.89 to 3361.87)	3065.4 (2530.54 to 3713.31)

No statistical analyses for this end point

Secondary: Number of subjects with any and Grade 3 solicited local symptoms during the primary vaccination phase

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End point title

Number of subjects with any and Grade 3 solicited local symptoms during the primary vaccination phase

End point description

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

End point type

Secondary

End point timeframe

During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	50	50	50	50	50	50
Units: Subjects
Any Pain, Dose 1	8	12	7	10	9	6
Grade 3 Pain, Dose 1	0	0	0	0	0	0
Any Redness, Dose 1	0	0	0	0	0	0
Grade 3 Redness, Dose 1	0	0	0	0	0	0
Any Swelling, Dose 1	0	0	0	0	1	1
Grade 3 Swelling, Dose 1	0	0	0	0	0	0
Any Pain, Dose 2	7	7	5	7	5	3
Grade 3 Pain, Dose 2	0	0	0	0	0	0
Any Redness, Dose 2	0	0	0	0	0	0
Grade 3 Redness, Dose 2	0	0	0	0	0	0
Any Swelling, Dose 2	0	1	0	1	0	0
Grade 3 Swelling, Dose 2	0	0	0	0	0	0
Any Pain, Dose 3	4	6	0	0	0	0
Grade 3 Pain, Dose 3	0	0	0	0	0	0
Any Redness, Dose 3	0	0	0	0	0	0
Grade 3 Redness, Dose 3	0	0	0	0	0	0
Any Swelling, Dose 3	0	0	0	0	0	0
Grade 3 Swelling, Dose 3	0	0	0	0	0	0
Any Pain, Across	17	23	12	15	13	9
Grade 3 Pain, Across	0	0	0	0	0	0
Any Redness, Across	0	0	0	0	0	0
Grade 3 Redness, Across	0	0	0	0	0	0
Any Swelling, Across	0	1	0	1	1	1
Grade 3 Swelling, Across	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the primary vaccination phase

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End point title

Number of subjects with any, grade 3 and related solicited general symptoms during the primary vaccination phase

End point description

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

End point type

Secondary

End point timeframe

During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	50	50	50	50	50	50
Units: Subjects
Any Drowsiness, Dose 1	0	0	0	1	0	0
Grade 3 Drowsiness, Dose 1	0	0	0	0	0	0
Related Drowsiness, Dose 1	0	0	0	1	0	0
Any Irritability, Dose 1	0	2	0	0	1	0
Grade 3 Irritability, Dose 1	0	0	0	0	0	0
Related Irritability, Dose 1	0	0	0	0	1	0
Any Loss of appetite, Dose 1	0	0	0	0	0	1
Grade 3 Loss of appetite, Dose 1	0	0	0	0	0	0
Related Loss of appetite, Dose 1	0	0	0	0	0	1
Any Fever, Dose 1	34	31	22	26	21	15
Grade 3 Fever, Dose 1	0	0	0	0	0	0
Related Fever, Dose 1	31	29	19	22	21	13
Any Drowsiness, Dose 2	0	0	0	0	0	0
Grade 2 Drowsiness, Dose 2	0	0	0	0	0	0
Related Drowsiness, Dose 2	0	0	0	0	0	0
Any Irritability, Dose 2	0	0	0	0	1	0
Grade 3 Irritability, Dose 2	0	0	0	0	0	0
Related Irritability, Dose 2	0	0	0	0	1	0
Any Loss of appetite, Dose 2	0	0	0	0	0	0
Grade 3 Loss of appetite, Dose 2	0	0	0	0	0	0
Related Loss of appetite, Dose 2	0	0	0	0	0	0
Any Fever, Dose 2	40	30	22	11	12	12
Grade 3 Fever, Dose 2	0	0	0	0	0	0
Related Fever, Dose 2	38	28	20	9	10	9
Any Drowsiness, Dose 3	0	0	0	0	0	0
Grade 3 Drowsiness, Dose 3	0	0	0	0	0	0
Related Drowsiness, Dose 3	0	0	0	0	0	0
Any Irritability, Dose 3	3	4	0	0	0	0
Grade 3 Irritability, Dose 3	0	0	0	0	0	0
Related Irritability, Dose 3	3	3	0	0	0	0
Any Loss of appetite, Dose 3	0	1	0	0	0	0
Grade 3 Loss of appetite, Dose 3	0	0	0	0	0	0
Related Loss of appetite, Dose 3	0	0	0	0	0	0
Any Fever, Dose 3	30	30	0	0	0	0
Grade 3 Fever, Dose 3	0	0	0	0	0	0
Related Fever, Dose 3	26	28	0	0	0	0
Any Drowsiness, Across Doses	0	0	0	1	0	0
Grade 3 Drowsiness, Across Doses	0	0	0	0	0	0
Related Drowsiness, Across Doses	0	0	0	1	0	0
Any Irritability, Across Doses	3	6	0	0	2	0
Grade 3 Irritability, Across Doses	0	0	0	0	0	0
Related Irritability, Across Doses	3	3	0	0	2	0
Any Loss of appetite, Across Doses	0	1	0	0	0	1
Grade 3 Loss of appetite, Across Doses	0	0	0	0	0	0
Related Loss of appetite, Across Doses	0	0	0	0	0	1
Any Fever, Across Doses	48	43	31	29	29	20
Grade 3 Fever, Across Doses	0	0	0	0	0	0
Related Fever, Across Doses	46	43	29	25	28	17

No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited adverse events (AEs)

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End point title

Number of subjects with any unsolicited adverse events (AEs)

End point description

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.

End point type

Secondary

End point timeframe

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

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	50	50	50	50	50	50
Units: Subjects
Any AEs post primary vaccination [N=50,50,50,50]	37	34	32	37	23	25
Any AEs post-booster vaccination [N=49,49,50,50]	8	17	18	12	0	0

No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs)

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End point title

Number of subjects with serious adverse events (SAEs)

End point description

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.

End point type

Secondary

End point timeframe

During the entire study period from Month 0 to Month 9

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	50	50	50	50	50	50
Units: Subjects
Any SAEs	3	9	3	4	2	2

No statistical analyses for this end point

Secondary: Number of subjects with any and grade 3 solicited local symptoms during the booster vaccination phase

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End point title

Number of subjects with any and grade 3 solicited local symptoms during the booster vaccination phase

End point description

End point type

Secondary

End point timeframe

During the 4-day (Days 0-3) post-booster vaccination period

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	49	49	50	50
Units: Subjects
Any Pain	11	6	3	0
Grade 3 Pain	0	0	0	0
Any Redness	0	0	0	0
Grade 3 Redness	0	0	0	0
Any Swelling	1	0	1	0
Grade 3 Swelling	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the booster vaccination phase

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End point title

Number of subjects with any, grade 3 and related solicited general symptoms during the booster vaccination phase

End point description

End point type

Secondary

End point timeframe

During the 4-day (Days 0-3) post-booster vaccination period

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	49	49	50	50
Units: Subjects
Any Drowsiness	0	0	0	0
Grade 3 Drowsiness	0	0	0	0
Related Drowsiness	0	0	0	0
Any Irritability	6	0	0	0
Grade 3 Irritability	0	0	0	0
Related Irritability	5	0	0	0
Any Loss of appetite	0	0	0	0
Grade 3 Loss of appetite	0	0	0	0
Related Loss of appetite	0	0	0	0
Any Fever	38	31	14	13
Grade 3 Fever	0	0	0	0
Related Fever	35	28	13	13

No statistical analyses for this end point

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

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End point title

Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines ^[5]

End point description

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after primary vaccination (Month 3), prior to (Month 8) and one month after (Month 9) booster vaccination

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	48	45
Units: Titer
geometric mean (confidence interval 95%)
Anti-6A [Month 0] (N=47,41)	0.10 (0.07 to 0.14)	0.15 (0.1 to 0.23)
Anti-6A [Month 3] (N=46,43)	0.12 (0.08 to 0.17)	0.10 (0.07 to 0.13)
Anti-6A [Month 8] (N=37,30)	0.40 (0.27 to 0.61)	0.18 (0.1 to 0.3)
Anti-6A [Month 9] (N=36,29)	0.48 (0.31 to 0.74)	0.36 (0.23 to 0.55)
Anti-19A [Month 0] (N=47,44)	0.24 (0.17 to 0.36)	0.23 (0.16 to 0.33)
Anti-19A [Month 3] (N=48,45)	0.26 (0.17 to 0.39)	0.25 (0.17 to 0.37)
Anti-19A [Month 8] (N=44,38)	0.23 (0.15 to 0.37)	0.21 (0.13 to 0.35)
Anti-19A [Month 9] (N=44,37)	1.09 (0.65 to 1.83)	0.85 (0.5 to 1.43)

No statistical analyses for this end point

Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

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End point title

Concentrations of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose ^[6]

End point description

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for Synflorix 7-11S Group and the Synflorix 7-11NS Group.

End point values	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	50	50
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-1 [Month 0] (N=48,46)	0.03 (0.03 to 0.03)	0.04 (0.03 to 0.05)
Anti-1 [Month 2] (N=50,48)	5.48 (4.34 to 6.93)	3.99 (3.24 to 4.91)
Anti-1 [Month 3] (N=50,49)	2.68 (2.12 to 3.39)	2.44 (1.99 to 2.98)
Anti-1 [Month 4] (N=49,48)	5.51 (4.27 to 7.1)	4.92 (3.74 to 6.48)
Anti-4 [Month 0] (N=49,50)	0.03 (0.03 to 0.04)	0.03 (0.02 to 0.04)
Anti-4 [Month 2] (N=49,47)	10.88 (8.94 to 13.24)	7.55 (6 to 9.5)
Anti-4 [Month 3] (N=50,48)	5.72 (4.66 to 7.03)	4.32 (3.51 to 5.32)
Anti-4 [Month 4] (N=49,48)	9.75 (7.67 to 12.39)	7.88 (6.28 to 9.89)
Anti-5 [Month 0] (N=48,50)	0.04 (0.03 to 0.06)	0.06 (0.05 to 0.08)
Anti-5 [Month 2] (N=50,47)	6.76 (5.14 to 8.89)	4.59 (3.58 to 5.88)
Anti-5 [Month 3] (N=50,49)	3.68 (2.87 to 4.73)	3.4 (2.66 to 4.33)
Anti-5 [Month 4] (N=49,48)	7.75 (6.05 to 9.92)	7.87 (6.02 to 10.29)
Anti-6B [Month 0] (N=49,46)	0.03 (0.02 to 0.03)	0.03 (0.02 to 0.03)
Anti-6B [Month 2] (N=49,49)	1.61 (1.03 to 2.52)	1.48 (1.02 to 2.13)
Anti-6B [Month 3] (N=50,49)	1.51 (1.06 to 2.15)	1.35 (0.98 to 1.87)
Anti-6B [Month 4] (N=49,48)	3.12 (2.1 to 4.64)	2.93 (2.17 to 3.95)
Anti-7F [Month 0] (N=50,50)	0.04 (0.03 to 0.05)	0.04 (0.03 to 0.05)
Anti-7F [Month 2] (N=49,49)	8.51 (6.94 to 10.42)	6.67 (5.44 to 8.19)
Anti-7F [Month 3] (N=50,49)	5.46 (4.37 to 6.83)	4.68 (3.76 to 5.81)
Anti-7F [Month 4] (N=48,48)	11.08 (8.9 to 13.81)	10.29 (7.92 to 13.37)
Anti-9V [Month 0] (N=49,48)	0.04 (0.03 to 0.05)	0.04 (0.03 to 0.05)
Anti-9V [Month 2] (N=49,49)	2.55 (1.86 to 3.49)	1.67 (1.21 to 2.29)
Anti-9V [Month 3] (N=50,49)	1.9 (1.42 to 2.56)	1.52 (1.16 to 2)
Anti-9V [Month 4] (N=49,48)	4.73 (3.4 to 6.58)	3.76 (2.67 to 5.3)
Anti-14 [Month 0] (N=47,48)	0.08 (0.06 to 0.12)	0.07 (0.05 to 0.1)
Anti-14 [Month 2] (N=50,46)	4.91 (3.48 to 6.95)	4.81 (3.67 to 6.29)
Anti-14 [Month 3] (N=50,49)	4.71 (3.45 to 6.43)	4.98 (4.01 to 6.2)
Anti-14 [Month 4] (N=49,48)	10.24 (7.96 to 13.18)	10.69 (8.34 to 13.71)
Anti-18C [Month 0] (N=50,49)	0.03 (0.03 to 0.03)	0.03 (0.03 to 0.04)
Anti-18C [Month 2] (N=49,47)	12.92 (9.93 to 16.82)	14.62 (11.61 to 18.4)
Anti-18C [Month 3] (N=50,49)	8.43 (6.53 to 10.88)	11.49 (9.24 to 14.29)
Anti-18C [Month 4] (N=49,48)	23.57 (18.38 to 30.22)	31.88 (25.34 to 40.11)
Anti-19F [Month 0] (N=49,48)	0.05 (0.04 to 0.06)	0.04 (0.04 to 0.06)
Anti-19F [Month 2] (N=50,49)	11.13 (7.97 to 15.54)	9.77 (6.16 to 15.48)
Anti-19F [Month 3] (N=50,49)	6.54 (4.79 to 8.92)	7.39 (5.04 to 10.81)
Anti-19F [Month 4] (N=49,48)	15.59 (11.24 to 21.62)	15.85 (10.52 to 23.89)
Anti-23F [Month 0] (N=48,48)	0.03 (0.03 to 0.04)	0.04 (0.03 to 0.05)
Anti-23F [Month 2] (N=50,48)	1.29 (0.79 to 2.1)	0.93 (0.6 to 1.45)
Anti-23F [Month 3] (N=50,48)	1 (0.65 to 1.56)	1.08 (0.74 to 1.56)
Anti-23F [Month 4] (N=49,48)	3.11 (1.85 to 5.24)	3.17 (2.04 to 4.91)

No statistical analyses for this end point

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

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End point title

Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose ^[7]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for Synflorix 7-11S Group and the Synflorix 7-11NS Group.

End point values	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	50	49
Units: Titer
geometric mean (confidence interval 95%)
Anti-6A [Month 0] (N=47,44)	0.03 (0.03 to 0.04)	0.03 (0.03 to 0.04)
Anti-6A [Month 2] (N=48,46)	0.18 (0.11 to 0.3)	0.16 (0.11 to 0.24)
Anti-6A [Month3] (N=50,47)	0.23 (0.14 to 0.37)	0.22 (0.16 to 0.32)
Anti-6A [Month 4] (N=48,48)	0.44 (0.28 to 0.7)	0.43 (0.3 to 0.62)
Anti-19A [Month 0] (N=48,49)	0.04 (0.03 to 0.06)	0.06 (0.04 to 0.1)
Anti-19A [Month 2] (N=50,49	0.46 (0.28 to 0.76)	0.77 (0.5 to 1.18)
Anti-19A [Month3] (N=50,48)	0.44 (0.27 to 0.7)	0.77 (0.51 to 1.17)
Anti-19A [Month 4] (N=49,48)	1.49 (0.93 to 2.38)	2.35 (1.5 to 3.67)

No statistical analyses for this end point

Secondary: Concentration of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

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End point title

Concentration of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose ^[8]

End point description

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

End point type

Secondary

End point timeframe

Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Synflorix 12-23S Group and the Synflorix 12-23NS Group.

End point values	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	48	47
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-1 [Month 0] (N=47,45)	0.04 (0.03 to 0.05)	0.04 (0.03 to 0.05)
Anti-1 [Month 2] (N=48,47)	1.39 (1.07 to 1.8)	1.49 (1.18 to 1.89)
Anti-1 [Month 3] (N=48,46)	4.67 (3.75 to 5.81)	4.26 (3.38 to 5.37)
Anti-4 [Month 0] (N=48,47)	0.04 (0.03 to 0.05)	0.04 (0.03 to 0.05)
Anti-4 [Month 2] (N=47,47)	4.22 (3.23 to 5.51)	3.74 (2.96 to 4.72)
Anti-4 [Month 3] (N=47,46)	8.87 (7.03 to 11.19)	7.02 (5.85 to 8.43)
Anti-5 [Month 0] (N=48,47)	0.06 (0.04 to 0.08)	0.08 (0.06 to 0.11)
Anti-5 [Month 2] (N=48,47)	1.06 (0.77 to 1.47)	1.1 (0.83 to 1.44)
Anti-5 [Month 3] (N=48,46)	5.52 (4.23 to 7.2)	4.07 (3.06 to 5.42)
Anti-6B [Month 0] (N=48,47)	0.03 (0.03 to 0.04)	0.04 (0.03 to 0.05)
Anti-6B [Month 2] (N=48,47)	0.41 (0.28 to 0.62)	0.34 (0.24 to 0.48)
Anti-6B [Month 3] (N=48,46)	1.37 (0.91 to 2.07)	1.25 (0.87 to 1.79)
Anti-7F [Month 0] (N=48,47)	0.07 (0.05 to 0.11)	0.05 (0.04 to 0.07)
Anti-7F [Month 2] (N=48,47)	2.74 (2.13 to 3.52)	3.17 (2.56 to 3.93)
Anti-7F [Month 3] (N=48,46)	6.81 (5.32 to 8.7)	6.36 (5.25 to 7.69)
Anti-9V [Month 0] (N=48,47)	0.08 (0.05 to 0.12)	0.05 (0.04 to 0.07)
Anti-9V [Month 2] (N=48,47)	0.99 (0.72 to 1.34)	0.83 (0.62 to 1.11)
Anti-9V [Month 3] (N=48,46)	2.35 (1.85 to 3)	1.72 (1.31 to 2.25)
Anti-14 [Month 0] (N=47,46)	0.11 (0.07 to 0.16)	0.09 (0.06 to 0.12)
Anti-14 [Month 2] (N=48,47)	1.87 (1.46 to 2.4)	1.24 (0.92 to 1.66)
Anti-14 [Month 3] (N=47,45)	7.59 (5.84 to 9.87)	5.75 (4.33 to 7.62)
Anti-18C [Month 0] (N=48,47)	0.04 (0.03 to 0.06)	0.05 (0.04 to 0.07)
Anti-18C [Month 2] (N=48,47)	6.21 (4.77 to 8.1)	6.12 (4.56 to 8.21)
Anti-18C [Month 3] (N=47,45)	25.52 (20.66 to 31.53)	22.64 (18.14 to 28.26)
Anti-19F [Month 0] (N=48,47)	0.06 (0.04 to 0.09)	0.08 (0.05 to 0.12)
Anti-19F [Month 2] (N=48,47)	5.88 (4.44 to 7.8)	5.12 (3.79 to 6.94)
Anti-19F [Month 3] (N=48,46)	18 (13.97 to 23.2)	14.46 (10.81 to 19.34)
Anti-23F [Month 0] (N=48,47)	0.03 (0.03 to 0.04)	0.05 (0.03 to 0.07)
Anti-23F [Month 2] (N=48,47)	0.5 (0.32 to 0.77)	0.35 (0.25 to 0.49)
Anti-23F [Month 3] (N=47,46)	1.95 (1.32 to 2.87)	1.4 (1.05 to 1.87)

No statistical analyses for this end point

Secondary: Concentration of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

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End point title

Concentration of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose ^[9]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Synflorix 12-23S Group and the Synflorix 12-23NS Group.

End point values	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	48	47
Units: Titers
geometric mean (confidence interval 95%)
Anti-6A [Month 0] (N=45,44)	0.03 (0.03 to 0.03)	0.04 (0.03 to 0.05)
Anti-6A [Month 2] (N=47,47)	0.15 (0.1 to 0.23)	0.12 (0.08 to 0.18)
Anti-6A [Month 3] (N=47,46)	0.39 (0.23 to 0.66)	0.31 (0.2 to 0.48)
Anti-19A [Month 0] (N=47,45)	0.06 (0.04 to 0.09)	0.07 (0.04 to 0.11)
Anti-19A [Month 2] (N=48,47)	0.77 (0.5 to 1.17)	0.75 (0.47 to 1.19)
Anti-19A [Month 3] (N=48,46)	3.15 (2.13 to 4.65)	2.79 (1.93 to 4.05)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

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End point title

Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines ^[10]

End point description

Opsonophagocytic activity has been assessed against vaccine 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) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	46	41
Units: Titer
geometric mean (confidence interval 95%)
Opsono-1 Month 3 (N=45,41)	106.4 (56 to 202.2)	94.6 (49.9 to 179.5)
Opsono-1 Month 8 (N=41,33)	11.7 (6.8 to 20.1)	10.9 (6 to 20.1)
Opsono-1 Month 9 (N=41,35)	930.5 (606.3 to 1427.9)	750.4 (401.4 to 1403)
Opsono-4 Month 3 (N=44,38)	1316.6 (1014 to 1709.7)	992.5 (680 to 1448.4)
Opsono-4 Month 8 (N=40,31)	222.1 (130.6 to 377.8)	108.3 (51.6 to 227.6)
Opsono-4 Month 9 (N=41,33)	2064.2 (1625.3 to 2621.8)	2079.3 (1425.7 to 3032.7)
Opsono-5 Month 3 (N=44,41)	106.9 (66.8 to 171.2)	119.4 (81.4 to 175.2)
Opsono-5 Month 8 (N=40,33)	14.9 (8.9 to 24.9)	15.8 (9.6 to 26.1)
Opsono-5 Month 9 (N=41,33)	273.2 (200.6 to 372)	277.5 (168.8 to 456.1)
Opsono-6B Month 3 (N=41,37)	1043.3 (605.3 to 1798.3)	446.2 (207.4 to 960)
Opsono-6B Month 8 (N=39,32)	285.3 (150.1 to 542.1)	245.6 (115 to 524.3)
Opsono-6B Month 9 (N=40,33)	952.2 (638.8 to 1419.3)	989.2 (530.6 to 1843.9)
Opsono-7F Month 3 (N=42,37)	4644.1 (3519.3 to 6128.4)	4924.2 (3430.2 to 7068.8)
Opsono-7F Month 8 (N=40,32)	1747.2 (1225.4 to 2491.3)	1585.7 (1133.8 to 2217.8)
Opsono-7F Month 9 (N=39,32)	7262.9 (5257.6 to 10033.1)	8120.3 (5802.1 to 11364.8)
Opsono-9V Month 3 (N=46,39)	1438.6 (1084 to 1909.3)	1116.8 (679.6 to 1835.2)
Opsono-9V Month 8 (N=38,32)	215.5 (97.5 to 476.1)	244.5 (123.9 to 482.2)
Opsono-9V Month 9 (N=40,32)	2062.3 (1569 to 2710.8)	2987.2 (2149.4 to 4151.6)
Opsono-14 Month 3 (N=44,41)	1689.9 (1090.7 to 2618.2)	1062.3 (562.8 to 2005.2)
Opsono-14 Month 8 (N=39,26)	215.9 (113.6 to 410.1)	132.5 (60.3 to 291.5)
Opsono-14 Month 9 (N=40,33)	1571.5 (1114.2 to 2216.4)	1454.1 (741.8 to 2850.5)
Opsono-18C Month 3 (N=40,37)	873.8 (591.7 to 1290.4)	524.7 (319.6 to 861.6)
Opsono-18C Month 8 (N=39,30)	46.5 (28.5 to 75.7)	28.7 (17.5 to 47.3)
Opsono-18C Month 9 (N=39,31)	1246 (776.7 to 1999)	1011.8 (686.4 to 1491.4)
Opsono-19F Month 3 (N=43,39)	558.9 (376.3 to 830.2)	266.1 (148.2 to 477.8)
Opsono-19F Month 8 (N=41,32)	60.7 (37.1 to 99.3)	43.4 (22.6 to 83.2)
Opsono-19F Month 9 (N=40,33)	652.9 (413.3 to 1031.5)	486.7 (278.9 to 849.4)
Opsono-23F Month 3 (N=44,37)	705.1 (309.2 to 1607.8)	759.7 (326.7 to 1766.6)
Opsono-23F Month 8 (N=36,31)	85.2 (27.5 to 264.4)	41.6 (14.6 to 118.9)
Opsono-23F Month 9 (N=39,33)	4231.2 (2793.7 to 6408.3)	1454 (736.1 to 2872.3)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

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End point title

Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines ^[11]

End point description

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (Opsono-6A, Opsono-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	42	41
Units: Titers
geometric mean (confidence interval 95%)
Opsono-6A [Month 3] (N=42,41)	24.73 (11.46 to 53.37)	9.45 (5.32 to 16.75)
Opsono-6A [Month 8] (N=40,33)	18.23 (8.97 to 37.09)	17.59 (8.08 to 38.3)
Opsono-6A [Month 9] (N=38,32)	35.35 (15.6 to 80.12)	30.7 (12.14 to 77.64)
Opsono-19A [Month 3] (N=38,34)	9.42 (5.65 to 15.7)	5.04 (3.83 to 6.63)
Opsono-19A [Month 8] (N=34,23)	6.31 (4.28 to 9.32)	5.83 (3.95 to 8.61)
Opsono-19A [Month 9] (N=26,28)	22.06 (9.49 to 51.3)	19.44 (10.25 to 36.86)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

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End point title

Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose ^[12]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for Synflorix 7-11S Group and the Synflorix 7-11NS Group.

End point values	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	49	45
Units: Titers
geometric mean (confidence interval 95%)
Opsono-6A [Month 2] (N=49,39)	40.59 (19.11 to 86.23)	51.23 (22.85 to 114.88)
Opsono-6A [Month 3] (N=44,45)	38.11 (17.04 to 85.21)	36.27 (16.89 to 77.89)
Opsono-6A [Month 4] (N=45,43)	77.09 (35.58 to 167.04)	98.18 (43.05 to 223.96)
Opsono-19A [Month 2] (N=40,31)	15.21 (7.95 to 29.08)	108.31 (49.55 to 236.78)
Opsono-19A [Month 3] (N=37,26)	14.65 (7.71 to 27.81)	19.4 (8.04 to 46.82)
Opsono-19A [Month 4] (N=31,29)	76.09 (30.5 to 189.83)	449.06 (170.05 to 1185.87)
Opsono-6A [Month 0] (N=46,40)	4.81 (3.71 to 6.24)	5.02 (3.64 to 6.90)
Opsono-19A [Month 0] (N=41,40)	4.49 (3.91 to 5.16)	4.33 (3.68 to 5.10)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

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End point title

Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose ^[13]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Synflorix 12-23S Group and the Synflorix 12-23NS Group.

End point values	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	47	45
Units: Titer
geometric mean (confidence interval 95%)
Opsono-1 Month 2 (N=46,45)	9.3 (6.1 to 14.3)	10.9 (6.8 to 17.4)
Opsono-1 Month 3 (N=45,43)	195.7 (119.9 to 319.3)	115.1 (64 to 206.8)
Opsono-4 Month 2 (N=44,43)	1086.3 (758.4 to 1555.9)	1539.4 (1128.4 to 2100.1)
Opsono-4 Month 3 (N=44,43)	2089.7 (1635 to 2670.8)	3193.9 (2241.3 to 4551.4)
Opsono-5 Month 2 (N=45,45)	9.8 (7.1 to 13.7)	9.6 (6.6 to 13.7)
Opsono-5 Month 3 (N=44,44)	151.3 (99.8 to 229.2)	84 (53.5 to 131.8)
Opsono-6B Month 2 (N=41,42)	345.1 (172.4 to 690.7)	278.4 (131.8 to 588.4)
Opsono-6B Month 3 (N=43,43)	748.4 (425.9 to 1315)	866.4 (511.8 to 1466.7)
Opsono-7F Month 2 (N=44,45)	5462.3 (4108.9 to 7261.4)	5802.2 (4678.6 to 7195.6)
Opsono-7F Month 3 (N=44,42)	10279.4 (7836.7 to 13483.6)	10131.4 (8303.7 to 12361.6)
Opsono-9V Month 2 (N=43,44)	1976.2 (1392.6 to 2804.4)	2359 (1514.3 to 3674.9)
Opsono-9V Month 3 (N=44,43)	3778.2 (2880 to 4956.4)	4276.8 (3122.3 to 5858.3)
Opsono-14 Month 2 (N=42,40)	711.2 (400.7 to 1262.4)	865.6 (583.2 to 1284.9)
Opsono-14 Month 3 (N=45,40)	2704.5 (1856.4 to 3940)	2737.5 (1890 to 3965.1)
Opsono-18C Month 2 (N=32,34)	1035.5 (507.6 to 2112.5)	449.2 (222.8 to 905.9)
Opsono-18C Month 3 (N=40,40)	2873.1 (2070 to 3987.6)	2126.8 (1509.7 to 2996.3)
Opsono-19F Month 2 (N=44,43)	229.1 (132.9 to 395)	248 (143 to 430.1)
Opsono-19F Month 3 (N=45,43)	1845.3 (1169.3 to 2912.1)	1271.4 (825.4 to 1958.3)
Opsono-23F Month 2 (N=44,44)	2572.2 (1264.1 to 5233.9)	2433.6 (1309.7 to 4522)
Opsono-23F Month 3 (N=42,41)	5016.6 (3176.6 to 7922.4)	5325.4 (2857.8 to 9923.9)
Opsono-1 Month 0 (N=47,43)	6.9 (4.5 to 10.8)	5.6 (4.2 to 7.6)
Opsono-4 Month 0 (N=46,44)	8.0 (4.7 to 13.6)	7.3 (4.3 to 12.3)
Opsono-5 Month 0 (N=47,45)	5.5 (4.2 to 7.4)	4.4 (3.6 to 5.4)
Opsono-6B Month 0 (N=41,38)	13.6 (6.7 to 27.6)	9.9 (5.2 to 18.7)
Opsono-7F Month 0 (N=44,36)	1436.6 (1014.4 to 2034.6)	1228.1 (783.3 to 1925.5)
Opsono-9V Month 0 (N=40,37)	119.5 (50.4 to 283.2)	81.3 (35.7 to 185.0)
Opsono-14 Month 0 (N=40,34)	16.3 (8.3 to 31.8)	12.0 (5.3 to 27.0)
Opsono-18C Month 0 (N=44,40)	4.9 (4.0 to 6.0)	4.0 (4.0 to 4.0)
Opsono-19F Month 0 (N=46,42)	5.5 (5.5 to 7.3)	4.0 (4.0 to 4.0)
Opsono-23F Month 0 (N=39,38)	68.1 (21.1 to 219.6)	37.6 (12.3 to 114.3)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

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End point title

Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose ^[14]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Synflorix 12-23S Group and the Synflorix 12-23NS Group.

End point values	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	44	42
Units: Titers
geometric mean (confidence interval 95%)
Opsono-6A [Month 2] (N=44,42)	82.82 (40.27 to 170.33)	77.25 (31.81 to 187.64)
Opsono-6A [Month 3] (N=40,39)	147.91 (63.11 to 346.68)	157.37 (59.23 to 418.11)
Opsono-19A [Month 2] (N=23,27)	28.37 (11.84 to 67.98)	25.68 (11.6 to 56.84)
Opsono-19A [Month 3] (N=19,23)	214.17 (75.58 to 606.93)	321.14 (144.75 to 712.5)
Opsono-6A [Month 0] (N=44,40)	9.26 (5.76 to 14.89)	6.35 (4.02 to 10.02)
Opsono-19A [Month 0] (N=44,40)	5.85 (4.27 to 8.01)	6.32 (4.09 to 9.76)

No statistical analyses for this end point

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination followed by a booster dose

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End point title

Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination followed by a booster dose ^[15]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for Synflorix 7-11S Group and the Synflorix 7-11NS Group.

End point values	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	50	50
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PD [Month 0] (N=47,48)	72.73 (57.23 to 92.42)	88.74 (70.85 to 111.13)
Anti-PD [Month 2] (N=50,50)	1313.39 (1014.3 to 1700.67)	1489.78 (1171.98 to 1893.76)
Anti-PD [Month 3] (N=50,49)	932.52 (732.63 to 1186.96)	1063.54 (844.52 to 1339.37)
Anti-PD [Month 4] (N=49,48)	2695.5 (2150.74 to 3378.24)	2638.27 (2049.91 to 3395.49)

No statistical analyses for this end point

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination without any booster dose

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End point title

Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination without any booster dose ^[16]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Synflorix 12-23S Group and the Synflorix 12-23NS Group.

End point values	Synflorix 12-23S Group	Synflorix 12-23NS Group
Number of subjects analysed	48	47
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PD [Month 0] (N=47,46)	79.59 (62.08 to 102.04)	76.22 (61.39 to 94.63)
Anti-PD [Month 2] (N=48,47)	199.23 (150.51 to 263.72)	184.34 (140.21 to 242.35)
Anti-PD [Month 3] (N=48,46)	1376.56 (1020.71 to 1856.46)	760.99 (553.23 to 1046.77)

No statistical analyses for this end point

Secondary: Concentration of antibodies against diphtheria toxoid (DT) and tetanus toxoid (TT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

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End point title

Concentration of antibodies against diphtheria toxoid (DT) and tetanus toxoid (TT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine ^[17]

End point description

Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	48	46
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-DT Month 0 (N=48,45)	0.07 (0.05 to 0.08)	0.06 (0.05 to 0.07)
Anti-DT Month 3 (N=48,46)	3.22 (2.59 to 4)	3.5 (2.82 to 4.34)
Anti-DT Month 8 (N=44,37)	0.62 (0.5 to 0.77)	0.9 (0.72 to 1.12)
Anti-DT Month 9 (N=44,38)	6.58 (5.44 to 7.97)	7.55 (6.11 to 9.32)
Anti-TT Month 0 (N=48,46)	1.54 (1.13 to 2.09)	1.22 (0.85 to 1.76)
Anti-TT Month 3 (N=48,46)	4.04 (3.26 to 5.01)	4.13 (3.27 to 5.22)
Anti-TT Month 8 (N=44,38)	1.19 (0.96 to 1.48)	1.33 (1.08 to 1.63)
Anti-TT Month 9 (N=44,38)	10.88 (9.24 to 12.81)	11.11 (9.62 to 12.83)

No statistical analyses for this end point

Secondary: Concentrations of antibodies against Bordetella pertussis (BPT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

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End point title

Concentrations of antibodies against Bordetella pertussis (BPT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine ^[18]

End point description

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the Tritanrix-HepB/Hib+Polio Sabin <6S Group and the Tritanrix-HepB/Hib+Polio Sabin <6NS Group.

End point values	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Number of subjects analysed	48	46
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-BPT Month 0 (N=48,46)	7.71 (7.29 to 8.16)	7.77 (7.39 to 8.17)
Anti-BPT Month 3 (N=48,46)	105.61 (86.93 to 128.3)	101.74 (84.56 to 122.42)
Anti-BPT Month 8 (N=44,38)	22.67 (17.45 to 29.45)	22.69 (17.88 to 28.8)
Anti-BPT Month 9 (N=44,38)	177.87 (152.1 to 207.99)	190.58 (167.67 to 216.63)

No statistical analyses for this end point

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

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End point title

Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose ^[19]

End point description

End point type

Secondary

End point timeframe

Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for Synflorix 7-11S Group and the Synflorix 7-11NS Group.

End point values	Synflorix 7-11S Group	Synflorix 7-11NS Group
Number of subjects analysed	49	47
Units: Titers
geometric mean (confidence interval 95%)
Opsono-1 Month 0 (N=47,43)	4.9 (3.8 to 6.3)	4.5 (3.6 to 5.7)
Opsono-1 Month 2 (N=48,45)	134.7 (83.6 to 216.9)	88.1 (53.7 to 144.6)
Opsono-1 Month 3 (N=48,46)	74.2 (42.6 to 129.3)	48 (26.6 to 86.7)
Opsono-1 Month 4 (N=48,44)	516.0 (307.6 to 865.7)	511.3 (293.2 to 891.8)
Opsono-4 Month 0 (N=44,44)	5.1 (3.6 to 7.2)	11.8 (5.7 to 24.5)
Opsono-4 Month 2 (N=49,44)	1636.3 (1217.5 to 2199.2)	1771.1 (1359.0 to 2308.2)
Opsono-4 Month 3 (N=45,45)	812.7 (584.5 to 1130.1)	1048.3 (790.4 to 1390.3)
Opsono-4 Month 4 (N=48,43)	2130.5 (1639.1 to 2769.2)	2415.5 (1686.5 to 3459.8)
Opsono-5 Month 0 (N=47,44)	4.4 (3.8 to 5.1)	4.0 (4.0 to 4.0)
Opsono-5 Month 2 (N=49,46)	105.7 (67.7 to 165.1)	85.8 (59.4 to 124.0)
Opsono-5 Month 3 (N=47,47)	54.1 (34.9 to 83.6)	49.2 (31.7 to 76.3)
Opsono-5 Month 4 (N=48,43)	277.4 (180.7 to 425.7)	289.6 (190.9 to 439.3)
Opsono-6B Month 0 (N=43,41)	7.9 (4.6 to 13.8)	8.5 (4.7 to 15.4)
Opsono-6B Month 2 (N=48,43)	702.5 (413.2 to 1194.2)	696.6 (388.5 to 1249.2)
Opsono-6B Month 3 (N=44,45)	708.3 (422.9 to 1186.1)	615.5 (337.3 to 1123.1)
Opsono-6B Month 4 (N=46,43)	1360.0 (860.2 to 2150.3)	1305.4 (731.9 to 2328.4)
Opsono-7F Month 0 (N=41,40)	215.3 (91.2 to 508.1)	643.5 (293.4 to 1411.7)
Opsono-7F Month 2 (N=47,40)	6694.3 (5055.1 to 8864.9)	10452.0 (7782.7 to 14036.6)
Opsono-7F Month 3 (N=46,46)	7776.9 (6000.8 to 10078.7)	9336.3 (6752.4 to 12908.9)
Opsono-7F Month 4 (N=47,39)	10854.8 (9051.6 to 13017.2)	9362.8 (6882.3 to 12737.3)
Opsono-9V Month 0 (N=42,44)	16.9 (8.3 to 34.5)	20.3 (9.2 to 44.5)
Opsono-9V Month 2 (N=48,42)	2858.2 (1875.3 to 4356.2)	2667.9 (1677.9 to 4242.0)
Opsono-9V Month 3 (N=44,46)	1982.9 (1192.1 to 3298.2)	1986.2 (1167.8 to 3378.2)
Opsono-9V Month 4 (N=48,41)	3047.9 (2389.7 to 3887.3)	2719.2 (1681.0 to 4398.9)
Opsono-14 Month 0 (N=40,39)	5.5 (3.8 to 8.1)	5.9 (3.8 to 9.1)
Opsono-14 Month 2 (N=44,43)	2109.5 (1299.0 to 3425.9)	4009.9 (2501.9 to 6426.7)
Opsono-14 Month 3 (N=46,46)	1431.6 (865.2 to 2368.6)	2128.3 (1477.5 to 3065.9)
Opsono-14 Month 4 (N=46,40)	3414.9 (2237.4 to 5211.9)	3717.3 (2403.9 to 5748.5)
Opsono-18C Month 0 (N=44,43)	4.1 (3.9 to 4.5)	4.6 (3.4 to 6.2)
Opsono-18C Month 2 (N=39,37)	744.4 (393.3 to 1409.2)	1605.6 (937.1 to 2751.1)
Opsono-18C Month 3 (N=40,42)	411.4 (214.4 to 789.7)	746.4 (430.5 to 1294.1)
Opsono-18C Month 4 (N=44,40)	2218.9 (1577.5 to 3121.2)	3238.7 (1874.7 to 5595.0)
Opsono-19F Month 0 (N=44,43)	4.2 (3.8 to 4.7)	4.0 (4.0 to 4.0)
Opsono-19F Month 2 (N=47,43)	393.4 (393.4 to 722.0)	491.5 (256.8 to 940.6)
Opsono-19F Month 3 (N=45,46)	160.2 (86.8 to 295.6)	279.5 (161.1 to 484.9)
Opsono-19F Month 4 (N=47,41)	1347.7 (813.6 to 2232.3)	1174.4 (605.6 to 2277.3)
Opsono-23F Month 0 (N=43,40)	7.6 (4.1 to 13.9)	15.3 (6.4 to 36.6)
Opsono-23F Month 2 (N=46,44)	1545.1 (788.3 to 3028.2)	2107.5 (1155.0 to 3845.5)
Opsono-23F Month 3 (N=40,46)	1168.8 (560.8 to 2435.8)	1026.2 (458.3 to 2298.0)
Opsono-23F Month 4 (N=47,43)	2038.8 (977.1 to 4254.4)	3525.1 (1974.2 to 6294.4)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.

Adverse event reporting additional description

The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Reporting group description

Reporting group title

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Reporting group description

Reporting group title

Synflorix 7-11S Group

Reporting group description

Reporting group title

Synflorix 7-11NS Group

Reporting group description

Reporting group title

Synflorix 12-23S Group

Reporting group description

Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Reporting group title

Synflorix 12-23NS Group

Reporting group description

Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Serious adverse events	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 50 (6.00%)	9 / 50 (18.00%)	3 / 50 (6.00%)	4 / 50 (8.00%)	2 / 50 (4.00%)	2 / 50 (4.00%)
number of deaths (all causes)	1	1	1	0	0	0
number of deaths resulting from adverse events
General disorders and administration site conditions
Pyrexia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Enteritis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Gastroenteritis
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 50 (2.00%)	6 / 50 (12.00%)	1 / 50 (2.00%)	2 / 50 (4.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 1	0 / 6	0 / 1	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malaria
alternative assessment type: Non-systematic
subjects affected / exposed	3 / 50 (6.00%)	3 / 50 (6.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	1 / 50 (2.00%)	2 / 50 (4.00%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 0	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 50 (2.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis Salmonella
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis acute
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Malnutrition
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Tritanrix-HepB/Hib+Polio Sabin <6S Group	Tritanrix-HepB/Hib+Polio Sabin <6NS Group	Synflorix 7-11S Group	Synflorix 7-11NS Group	Synflorix 12-23S Group	Synflorix 12-23NS Group
Total subjects affected by non serious adverse events
subjects affected / exposed	50 / 50 (100.00%)	49 / 50 (98.00%)	47 / 50 (94.00%)	47 / 50 (94.00%)	41 / 50 (82.00%)	31 / 50 (62.00%)
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
subjects affected / exposed	1 / 50 (2.00%)	0 / 50 (0.00%)	3 / 50 (6.00%)	0 / 50 (0.00%)	10 / 50 (20.00%)	0 / 50 (0.00%)
occurrences all number	1	0	5	0	13	0
General disorders and administration site conditions
Pain
subjects affected / exposed	23 / 50 (46.00%)	26 / 50 (52.00%)	15 / 50 (30.00%)	15 / 50 (30.00%)	14 / 50 (28.00%)	9 / 50 (18.00%)
occurrences all number	30	31	17	17	16	9
Pyrexia
subjects affected / exposed	49 / 50 (98.00%)	47 / 50 (94.00%)	37 / 50 (74.00%)	35 / 50 (70.00%)	29 / 50 (58.00%)	21 / 50 (42.00%)
occurrences all number	143	123	63	52	33	28
Eye disorders
Conjunctivitis
subjects affected / exposed	2 / 50 (4.00%)	3 / 50 (6.00%)	1 / 50 (2.00%)	1 / 50 (2.00%)	2 / 50 (4.00%)	0 / 50 (0.00%)
occurrences all number	2	3	1	1	2	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	8 / 50 (16.00%)	6 / 50 (12.00%)	4 / 50 (8.00%)	4 / 50 (8.00%)	1 / 50 (2.00%)	1 / 50 (2.00%)
occurrences all number	8	6	4	4	1	1
Enteritis
subjects affected / exposed	2 / 50 (4.00%)	5 / 50 (10.00%)	7 / 50 (14.00%)	4 / 50 (8.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)
occurrences all number	2	5	7	4	0	1
Abdominal pain
subjects affected / exposed	3 / 50 (6.00%)	1 / 50 (2.00%)	2 / 50 (4.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	3	1	2	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	4 / 50 (8.00%)	5 / 50 (10.00%)	3 / 50 (6.00%)	2 / 50 (4.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)
occurrences all number	4	5	3	2	1	0
Psychiatric disorders
Irritability
subjects affected / exposed	9 / 50 (18.00%)	6 / 50 (12.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	2 / 50 (4.00%)	0 / 50 (0.00%)
occurrences all number	9	6	0	0	2	0
Infections and infestations
Malaria
subjects affected / exposed	10 / 50 (20.00%)	13 / 50 (26.00%)	18 / 50 (36.00%)	18 / 50 (36.00%)	10 / 50 (20.00%)	8 / 50 (16.00%)
occurrences all number	10	14	19	20	10	8
Bronchitis
subjects affected / exposed	9 / 50 (18.00%)	10 / 50 (20.00%)	6 / 50 (12.00%)	9 / 50 (18.00%)	1 / 50 (2.00%)	4 / 50 (8.00%)
occurrences all number	10	12	6	10	1	4
Gastroenteritis
subjects affected / exposed	6 / 50 (12.00%)	6 / 50 (12.00%)	3 / 50 (6.00%)	7 / 50 (14.00%)	1 / 50 (2.00%)	5 / 50 (10.00%)
occurrences all number	6	7	3	7	1	5
Rhinitis
subjects affected / exposed	4 / 50 (8.00%)	7 / 50 (14.00%)	5 / 50 (10.00%)	4 / 50 (8.00%)	3 / 50 (6.00%)	4 / 50 (8.00%)
occurrences all number	4	7	6	4	3	4
Nasopharyngitis
subjects affected / exposed	7 / 50 (14.00%)	5 / 50 (10.00%)	3 / 50 (6.00%)	8 / 50 (16.00%)	4 / 50 (8.00%)	5 / 50 (10.00%)
occurrences all number	7	6	3	8	4	5
Gastrointestinal fungal infection
subjects affected / exposed	4 / 50 (8.00%)	6 / 50 (12.00%)	3 / 50 (6.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
occurrences all number	5	6	3	1	0	0
Ear infection
subjects affected / exposed	3 / 50 (6.00%)	2 / 50 (4.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)
occurrences all number	3	2	0	1	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

15 Apr 2010

The oral polio vaccine was to be provided in multidose vials Changes in the randomization of treatment Inconsistencies regarding the age for booster vaccination in the 7-11 month groups Changes in the priority ranking of immunological assays Changes in the definition of the Epochs Update of Rationale of the study

03 Sep 2010

•For clarification, the inclusion criteria for children with sickle cell disease have been further detailed. •An additional blood sample for SCD testing was planned to be taken at the pre-vaccination timepoint from subjects aged 7-11 and 12-23 months without hemoglobin status confirmed by electrophoresis available. •Presentation of oral polio vaccine that was to be used has changed: 10- or 20-dose vials were used. In addition, the use of one 10- or 20-dose vial to vaccinate up to 10 or 20 subjects, respectively, on the same day was allowed. •The immunogenicity objectives related to the co-administered OPV have been removed since there are no plans to test poliovirus immune response. •The contact details for the emergency code break have been clarified.

08 May 2012

The main changes and their rationale are the following: •Additional information was given about administration of vaccines through the local EPI program. •Extension of the recruitment period due to a lower enrolment rate than expected. •Additional exclusion criterion for children of the <6S and <6NS groups to clarify differences between groups with regard to administration of vaccines included in the EPI program either as study vaccines or outside the study. •Additional exclusion criterion for all groups, i.e. exclusion of subjects being heterozygous or carriers of abnormal haemoglobin (e.g. haemoglobin S, haemoglobin C) who are not considered to have SCD, to avoid potential bias and to keep homogeneity of the examined groups.

09 Apr 2013

In the past few months, GSK Biologicals has been investigating the quality of some serology assays used in clinical studies, including the Streptococcus pneumonia opsonophagocytic activity (OPA) assay used in the present trial. This protocol amendment reflected the fact that delays in the availability of the assay results would lead to changes in the analysis plan. Therefore, the sequence of analysis has been modified to perform study analysis in one final step on all immunogenicity and safety data obtained up to one month after administration of the last dose of study vaccine for all study groups. The results of this final analysis were presented in a final clinical study report.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Primary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Primary: Concentrations of antibodies against protein D (PD) for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Primary: Concentrations of antibodies against protein D (PD) for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Number of subjects with any and Grade 3 solicited local symptoms during the primary vaccination phase

Secondary: Number of subjects with any and Grade 3 solicited local symptoms during the primary vaccination phase

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the primary vaccination phase

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the primary vaccination phase

Secondary: Number of subjects with any unsolicited adverse events (AEs)

Secondary: Number of subjects with any unsolicited adverse events (AEs)

Secondary: Number of subjects with serious adverse events (SAEs)

Secondary: Number of subjects with serious adverse events (SAEs)

Secondary: Number of subjects with any and grade 3 solicited local symptoms during the booster vaccination phase

Secondary: Number of subjects with any and grade 3 solicited local symptoms during the booster vaccination phase

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the booster vaccination phase

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms during the booster vaccination phase

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentration of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects receiving Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Opsonophagocytic titers against cross-reactive pneumococcal serotypes for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against protein D (PD) for subjects who received a two-dose primary vaccination without any booster dose

Secondary: Concentration of antibodies against diphtheria toxoid (DT) and tetanus toxoid (TT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

Secondary: Concentration of antibodies against diphtheria toxoid (DT) and tetanus toxoid (TT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

Secondary: Concentrations of antibodies against Bordetella pertussis (BPT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

Secondary: Concentrations of antibodies against Bordetella pertussis (BPT) for subjects who were co-administered Tritanrix-HepB/Hib vaccine

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Secondary: Opsonophagocytic titers against vaccine pneumococcal serotypes for subjects who received a two-dose primary vaccination followed by a booster dose

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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