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Clinical Trial Results:
A Phase II, open-label, randomised controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine (M72/AS01E) when administered intramuscularly according to different immunisation schedules to healthy infants, living in a TB-endemic region

Summary
EudraCT number	2012-004380-44
Trial protocol	Outside EU/EEA
Global end of trial date	16 Mar 2012

Results information
Results version number	v4(current)
This version publication date	19 Apr 2023
First version publication date	18 Jul 2015
Other versions	v1 , v2 , v3
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

112899

ISRCTN number

US NCT number

NCT01098474

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)

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

17 Jul 2012

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Apr 2011

Global end of trial reached?

Yes

Global end of trial date

16 Mar 2012

Was the trial ended prematurely?

Main objective of the trial

To evaluate the safety of 1 or 2 doses of the TB candidate vaccine when given to healthy infants concomitantly with the EPI regimen containing the DTPw-HBV/Hib, 7Pn and OPV vaccines. To evaluate the safety of 1 or 2 doses of the TB candidate vaccine when given to healthy infants after receiving the EPI vaccines containing the DTPw-HBV/Hib, 7Pn and OPV vaccines.

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

07 Jul 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Gambia: 301

Worldwide total number of subjects

301

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)

301

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

One enrolled subject was not administered any vaccine and hence was not considered as having started the study.

Number of subjects started

301

Number of subjects completed

300

Reason: Number of subjects

No vaccination received: 1

Period 1 title

Active Phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

SB692342 2 dose Group

Arm description

Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, on a 0, 1 month schedule after having completed their primary EPI regimen.

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Two doses of 0,5 mL vaccine were administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1 month schedule after having completed their primary EPI regimen.

SB692342 1 dose Group

Arm description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of 0,5 mL vaccine was administered intramuscularly in the anterolateral region of the right thigh, at Month 0,after having completed their primary EPI regimen.

Control Menjugate Group

Arm description

Subjects received three doses of the control Menjugate vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first two doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.

Arm type

Active comparator

Investigational medicinal product name

Menjugate

Investigational medicinal product code

Other name

MenC

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of the 0,5 mL control vaccine were administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first 2 doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.

SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group

Arm description

Subjects received two doses of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, 1 month apart, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix HepB+Hiberix vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin vaccine, administered orally, and Prevnar vaccine, administered instramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Two doses of GSK’s investigational vaccine 692342 (0,5 mL)were administered, 1 Month apart, intramuscularly in the anterolateral region of the right thigh, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix, HepB+Hiberix, Polio Sabin and Prevnar, on a 1, 2 months schedule.

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last two doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, received intramuscularly in the anterolateral region of the left thigh, Polio Sabin and Prevnar were administered together with two doses of GSK’s investigational vaccine 692342, on a 1, 2 months schedule.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

SB692392 1 dose +Tritanrix + Prevnar+ Polio Sabin Group

Arm description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin vaccine, administered orally, and Prevnar vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of GSK’s investigational vaccine 692342 (0,5 mL) was administered, intramuscularly in the anterolateral region of the right thigh, concommitantly with the last dose of the primary EPI regimen containing Tritanrix, HepB+Hiberix, Polio Sabin and Prevnar, at month 2.

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix, received intramuscularly in the anterolateral region of the left thigh, Polio Sabin and Prevnar was administered together with one dose of GSK’s investigational vaccine 692342, at month 2.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin received orally and Prevnar was administered together with one dose of GSK’s investigational vaccine 692342, at month 2.

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar received intramuscularly in the right arm, was administered together with one dose of GSK’s investigational vaccine 692342, at month 2.

Control Tritanrix + Prevnar + Polio Sabin Group

Arm description

Subjects received three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix vaccine, administered in the anterolateral region of the left thigh, Polio Sabin vaccine, administered orally, and Prevnar vaccine administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Arm type

Active comparator

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

Number of subjects in period 1 ^[1]	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group	SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose +Tritanrix + Prevnar+ Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Started	50	50	50	49	52	49
Completed	48	49	45	49	52	49
Not completed	2	1	5	0	0	0
Consent withdrawn by subject	1	1	2	-	-	-
Unspecified	-	-	3	-	-	-
Lost to follow-up	1	-	-	-	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: One enrolled subject was not administered any vaccine and hence was not considered as having started the study.

Period 2 title

Follow-up Phase

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Two doses of GSK’s investigational vaccine 692342 (0,5 mL) were administered, 1 Month apart, intramuscularly in the anterolateral region of the right tight, concomintantly with the last two doses of the primary EPI regimen containing Tritanrix, HepB+Hiberix, Polio Sabin and Prevnar, at month 1 and 2 during the active phase.

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last two doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, received intramuscularly in the anterolateral region of the left thight, Polio Sabin and Prevnar were administered together with two doses of GSK’s investigational vaccine 692342. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

The last two doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin received orally and Prevnar were administered together with two doses of GSK’s investigational vaccine 692342. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last two doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar received instramuscularly in the right arm, were administered together with two doses of GSK’s investigational vaccine 692342. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of GSK’s investigational vaccine 692342 (0,5 mL) was were administered, 1 Month apart, intramuscularly in the anterolateral region of the right thight, concomintantly with the last dose of the primary EPI regimen containing Tritanrix™ HepB+Hiberix™, Polio Sabin™ administered orally and Prevnar® administered intramuscularly in the right arm.

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix, received intramuscularly in the anterolateral region of the left thigh, Polio Sabin and Prevnar were administered together with one dose of GSK’s investigational vaccine 692342.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix , Polio Sabin received orally and Prevnar were administered together with one dose of GSK’s investigational vaccine 692342.

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

The last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar received instramuscularly in the right arm, were administered together with one dose of GSK’s investigational vaccine 692342.

Control Tritanrix + Prevnar + Polio Sabin Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Tritanrix HepB+Hiberix

Investigational medicinal product code

Other name

DTPw-HBV/Hib

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

Investigational medicinal product name

Prevnar

Investigational medicinal product code

Other name

7Pn

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

Investigational medicinal product name

Polio Sabin

Investigational medicinal product code

Other name

OPV

Pharmaceutical forms

Suspension for injection

Routes of administration

Oral use

Dosage and administration details

Three doses of the primary EPI regimen containing Tritanrix HepB+Hiberix, Polio Sabin and Prevnar were administered on a 0, 1, 2 Months schedule.

SB692342 2 dose Group

Arm description

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Two doses of 0,5 mL vaccine were administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1 month schedule after having completed their primary EPI regimen.

SB692342 1 dose Group

Arm description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Arm type

Experimental

Investigational medicinal product name

GSK Biologicals’ candidate tuberculosis vaccine (692342)

Investigational medicinal product code

Other name

SB692342

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose of 0,5 mL vaccine was administered intramuscularly in the anterolateral region of the right thigh, at Month 0,after having completed their primary EPI regimen.

Control Menjugate Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Menjugate

Investigational medicinal product code

Other name

MenC

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Three doses of 0,5 mL control vaccine were administered intramuscularly in the anterolateral region of the right thigh, on a 0, 1, 7 months schedule. The first 2 doses were administered 1 month apart during the primary vaccination phase and the third dose was administered 6 months after the last primary vaccination dose.

Number of subjects in period 2	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Started	49	52	49	48	49	45
Completed	47	50	44	48	49	45
Not completed	2	2	5	0	0	0
Consent withdrawn by subject	2	-	1	-	-	-
Travelled out of study area	-	1	-	-	-	-
Unspecified	-	-	4	-	-	-
Lost to follow-up	-	1	-	-	-	-

Baseline characteristics

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Reporting group title

SB692342 2 dose Group

Reporting group description

Reporting group title

SB692342 1 dose Group

Reporting group description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Reporting group title

Control Menjugate Group

Reporting group description

Reporting group title

SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692392 1 dose +Tritanrix + Prevnar+ Polio Sabin Group

Reporting group description

Reporting group title

Control Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group	SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose +Tritanrix + Prevnar+ Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group	Total
Number of subjects	50	50	50	49	52	49	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	49	52	49	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
Age continuous
Units: months
arithmetic mean (standard deviation)	5.8 ± 0.68	5.7 ± 0.61	5.7 ± 0.65	2.1 ± 0.28	2 ± 0.19	2.1 ± 0.31	-
Gender categorical
Units: Subjects
Female	34	20	23	25	16	23	141
Male	16	30	27	24	36	26	159

End points

Top of page

Reporting group title

SB692342 2 dose Group

Reporting group description

Reporting group title

SB692342 1 dose Group

Reporting group description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Reporting group title

Control Menjugate Group

Reporting group description

Reporting group title

SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692392 1 dose +Tritanrix + Prevnar+ Polio Sabin Group

Reporting group description

Reporting group title

Control Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

Control Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692342 2 dose Group

Reporting group description

Reporting group title

SB692342 1 dose Group

Reporting group description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Reporting group title

Control Menjugate Group

Reporting group description

Primary: Number of subjects with grade 3 solicited local symptoms after dose 1, dose 2 and across doses

Top of page

End point title

Number of subjects with grade 3 solicited local symptoms after dose 1, dose 2 and across doses ^[1] ^[2]

End point description

Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

End point type

Primary

End point timeframe

From Day 0 to Day 6

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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Grade 3 Pain, D1 (N=50,50,50)	0	0	0
Grade 3 Swelling, D1 (N=50,50,50)	0	0	0
Grade 3 Pain, D2 (N=49,0 ,48)	0	0	0
Grade 3 Swelling, D2 (N=49,0,48)	0	0	0
Grade 3 Pain, Across (N=50,50,50)	0	0	0
Grade 3 Swelling, Across (N=50,50,50)	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 solicited local symptoms after dose 2, dose 3 and across doses

Top of page

End point title

Number of subjects with grade 3 solicited local symptoms after dose 2, dose 3 and across doses ^[3]

End point description

Solicited local symptoms were only collected after Dose 2 of EPI vaccination. Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

End point type

Primary

End point timeframe

From Day 0 to Day 6

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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	47	52	48
Units: Subjects
Grade 3 Pain, D2 (N=47,0 ,47)	0	0	0
Grade 3 Swelling, D2 (N=47,0,47)	2	0	2
Grade 3 Pain, D3 (N=47,52,48)	2	0	0
Grade 3 Swelling, D3 (N=47,52,48)	3	6	3
Grade 3 Pain, Across (N=47,52,48)	2	0	0
Grade 3 Swelling, Across (N=47,52,48)	3	6	5

No statistical analyses for this end point

Primary: Number of subjects with grade 3 solicited general symptoms after dose 1, dose 2 and across doses

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End point title

Number of subjects with grade 3 solicited general symptoms after dose 1, dose 2 and across doses ^[4] ^[5]

End point description

Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.

End point type

Primary

End point timeframe

From Day 0 to Day 6

Notes
[4] - 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.
[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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Grade 3 Drowsiness, D1 (N=50,50,50)	0	0	0
Grade 3 Irritability, D1 (N=50,50,50)	0	0	0
Grade 3 Loss of appetite, D1 (N=50,50,50)	0	0	0
Grade 3 Temperature /Axillary, D1 (N=50,50,50)	0	0	0
Grade 3 Drowsiness, D2 (N=49,0 ,48)	0	0	0
Grade 3 Irritability, D2 (N=49,0,48)	0	0	0
Grade 3 Loss of appetite, D2 (N=49,0,48)	0	0	0
Grade 3 Temperature/Axillary, D2 (N=49,0,48)	0	0	1
Grade 3 Drowsiness, Across (N=50,50,50)	0	0	0
Grade 3 Irritability, Across (N=50,50,50)	0	0	0
Grade 3 Loss of appetite, Across (N=50,50,50)	0	0	0
Grade 3 Fever/Axillary, Across (N=50,50,50)	0	0	1

No statistical analyses for this end point

Primary: Number of subjects with grade 3 solicited general symptoms after dose 2, dose 3 and across doses

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End point title

Number of subjects with grade 3 solicited general symptoms after dose 2, dose 3 and across doses ^[6]

End point description

Solicited general symptoms were only collected after Dose 2 of EPI vaccination. Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.

End point type

Primary

End point timeframe

From Day 0 to Day 6

Notes
[6] - 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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	47	52	48
Units: Subjects
Grade 3 Drowsiness, D2 (N=47,0 ,47)	0	0	0
Grade 3 Irritability, D2 (N=47,0,47)	0	0	0
Grade 3 Loss of appetite, D2 (N=47,0,47)	0	0	0
Grade 3 Temperature/Axillary, D2 (N=47,0,47)	0	0	0
Grade 3 Drowsiness, D3 (N=47,52,48)	0	0	0
Grade 3 Irritability, D3 (N=47,52,48)	2	0	0
Grade 3 Loss of appetite, D3 (N=47,52,48)	0	0	0
Grade 3 Temperature/Axillary, D3 (N=47,52,48)	0	0	0
Grade 3 Drowsiness, Across (N=47,52,48)	0	0	0
Grade 3 Irritability, Across (N=47,52,48)	2	0	0
Grade 3 Loss of appetite, Across (N=47,52,48)	0	0	0
Grade 3 Fever/Axillary, Across (N=47,52,48)	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 unsolicited adverse events (AEs)

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End point title

Number of subjects with grade 3 unsolicited adverse events (AEs) ^[7] ^[8]

End point description

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

End point type

Primary

End point timeframe

From Day 0 to Day 29

Notes
[7] - 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.
[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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	47	50	52	50	48
Units: Subjects
Grade 3 AEs	28	25	27	14	26	22

No statistical analyses for this end point

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

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End point title

Number of subjects with serious adverse events (SAEs) ^[9] ^[10]

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

Primary

End point timeframe

From Month 0 to Month 17

Notes
[9] - 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.
[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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	50	52	50	49
Units: Subjects
Any SAEs	0	1	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[11] ^[12]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: lesser than (<) 5.0 grams per deciliter (g/dL); WBC.: 1.0 to 1.4 x 10³/micro liter (µL); PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x upper limit of normal (ULN) and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

At Day 0

Notes
[11] - 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.
[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 the SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	50	52	50	49
Units: Subjects
Haem, PRE, Grade 3	0	0	0	0	0	0
WBC, PRE, Grade 3	0	0	0	0	0	0
PLA, PRE, Grade 3	0	0	0	0	0	0
ALA, PRE, Grade 3	0	0	0	0	0	0
CREA PRE, Grade 3	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[13] ^[14]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Seven days post Dose 1, at Day 7 [PI(D7)]

Notes
[13] - 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.
[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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Haem, PI(D7), Grade 3	0	0	0
WBC, PI(D7) Grade 3	0	0	0
PLA, PI(D7), Grade 3	0	0	0
ALA, PI(D7), Grade 3	0	0	0
CREA PI(D7), Grade 3	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[15] ^[16]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Seven days post Dose 2, at Day 37 [PII(D37)]

Notes
[15] - 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.
[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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	52	50	49
Units: Subjects
Haem, PII(D37), Grade 3	0	0	0	0	0
WBC, PII(D37) Grade 3	0	0	0	0	0
PLA, PII(D37), Grade 3	0	0	0	0	0
ALA, PII(D37), Grade 3	0	0	0	0	0
CREA PII(D37), Grade 3	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[17]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Seven days post Dose 3, at Day 67 [PIII(D67)]

Notes
[17] - 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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(D67), Grade 3	0	0	0
WBC, PIII(D67) Grade 3	0	0	0
PLA, PIII(D67), Grade 3	0	0	0
ALA, PIII(D67), Grade 3	0	0	0
CREA PIII(D67), Grade 3	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[18] ^[19]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

One Month post Dose 1, at Month 1 [PI(M1)]

Notes
[18] - 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.
[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 the SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Haem, PI(M1), Grade 3	0	0	0
WBC, PI(M1) Grade 3	0	0	0
PLA, PI(M1), Grade 3	0	0	0
ALA, PI(M1), Grade 3	0	0	0
CREA PI(M1), Grade 3	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[20] ^[21]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

One Month post Dose 2, at Month 2 [PII(M2)]

Notes
[20] - 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.
[21] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M2), Grade 3	0	0
WBC, PII(M2) Grade 3	0	0
PLA, PII(M2), Grade 3	0	0
ALA, PII(M2), Grade 3	0	0
CREA PII(M2), Grade 3	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[22]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

One Month post Dose 3, at Month 3 [PIII(M3)]

Notes
[22] - 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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(M3), Grade 3	0	0	0
WBC, PIII(M3) Grade 3	0	0	0
PLA, PIII(M3), Grade 3	0	0	0
ALA, PIII(M3), Grade 3	0	0	0
CREA PIII(M3), Grade 3	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[23] ^[24]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Six Months post Dose 1, at Month 6 [PI(M6)]

Notes
[23] - 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.
[24] - 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 SB692342 1 dose Group from the baseline period.

End point values	SB692342 1 dose Group
Number of subjects analysed	50
Units: Subjects
Haem, PI(M6), Grade 3	0
WBC, PI(M6) Grade 3	0
PLA, PI(M6), Grade 3	0
ALA, PI(M6), Grade 3	0
CREA PI(M6), Grade 3	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[25] ^[26]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Six Months post Dose 2, at Month 7 [PII(M7)]

Notes
[25] - 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.
[26] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M7), Grade 3	0	0
WBC, PII(M7) Grade 3	0	0
PLA, PII(M7), Grade 3	0	0
ALA, PII(M7), Grade 3	0	0
CREA PII(M7), Grade 3	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[27] ^[28]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Six Months post Dose 3, at Month 13 [PIII(M13)]

Notes
[27] - 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.
[28] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PIII(M13), Grade 3	0	0
WBC, PIII(M13) Grade 3	0	0
PLA, PIII(M13), Grade 3	0	0
ALA, PIII(M13), Grade 3	0	0
CREA PIII(M13), Grade 3	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[29] ^[30]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Twelve Months post Dose 1, at Month 12 [PI(M12)]

Notes
[29] - 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.
[30] - 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 SB692342 2 dose Group from the baseline period.

End point values	SB692342 2 dose Group
Number of subjects analysed	50
Units: Subjects
Haem, PI(M12), Grade 3	0
WBC, PI(M12) Grade 3	0
PLA, PI(M12), Grade 3	0
ALA, PI(M12), Grade 3	0
CREA PI(M12), Grade 3	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

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End point title

Number of subjects with grade 3 haematological and biochemical levels ^[31] ^[32]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Twelve Months post Dose 2, at Month 13 [PII(M13)]

Notes
[31] - 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.
[32] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M13), Grade 3	0	0
WBC, PII(M13) Grade 3	0	0
PLA, PII(M13), Grade 3	0	0
ALA, PII(M13), Grade 3	0	0
CREA PII(M13), Grade 3	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

Top of page

End point title

Number of subjects with grade 3 haematological and biochemical levels ^[33]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Twelve Months post Dose 3, at Month 14 [PIII(M14)]

Notes
[33] - 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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(M14), Grade 3	0	0	0
WBC, PIII(M14) Grade 3	0	0	0
PLA, PIII(M14), Grade 3	0	0	1
ALA, PIII(M14), Grade 3	0	0	0
CREA PIII(M14), Grade 3	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with grade 3 haematological and biochemical levels

Top of page

End point title

Number of subjects with grade 3 haematological and biochemical levels ^[34]

End point description

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.

End point type

Primary

End point timeframe

Six Months post Dose 3, at Month 8 [PIII(M8)]

Notes
[34] - 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.

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	50	49
Units: Subjects
Haem, PIII(M8), Grade 3	0	0	0
WBC, PIII(M8) Grade 3	0	0	0
PLA, PIII(M8), Grade 3	0	0	0
ALA, PIII(M8), Grade 3	0	1	0
CREA PIII(M8), Grade 3	0	0	0

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

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End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers ^[35]

End point description

Immune markers expressed were among Interleukin-2 (IL-2),Interferon-gamma (INF-γ),Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Before vaccination (PRE)

Notes
[35] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	37	36	42	39	34	39
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD4 all doubles, PRE	47 (23 to 87)	59.5 (30.5 to 125)	42.5 (22 to 71)	88 (27 to 181)	44.5 (11 to 65)	52 (33 to 149)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 (1 to 1)	1 (1 to 24.5)	1 (1 to 12)	14 (1 to 53)	1 (1 to 15)	1 (1 to 30)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE	1 (1 to 12)	1 (1 to 12)	1 (1 to 1)	1 (1 to 17)	1 (1 to 1)	1 (1 to 14)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE	1 (1 to 11)	1 (1 to 13)	1 (1 to 1)	1 (1 to 15)	1 (1 to 1)	1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE	14 (1 to 51)	1 (1 to 28)	11.5 (1 to 41)	3 (1 to 62)	1 (1 to 16)	1 (1 to 52)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 (1 to 12)	1 (1 to 24)	1 (1 to 12)	1 (1 to 27)	1 (1 to 1)	1 (1 to 27)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE	1 (1 to 12)	1 (1 to 6)	1 (1 to 12)	1 (1 to 1)	1 (1 to 11)	1 (1 to 16)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE	1 (1 to 1)	1 (1 to 11.5)	1 (1 to 1)	1 (1 to 20)	1 (1 to 1)	1 (1 to 15)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE	1 (1 to 38)	5.5 (1 to 29.5)	1 (1 to 40)	28 (1 to 63)	1 (1 to 40)	20 (1 to 62)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE	1 (1 to 1)	1 (1 to 12.5)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE	1 (1 to 11)	1 (1 to 27.5)	1 (1 to 19)	1 (1 to 11)	1.5 (1 to 14)	1 (1 to 21)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE	1 (1 to 11)	1 (1 to 21.5)	1 (1 to 13)	12 (1 to 47)	1 (1 to 22)	15 (1 to 49)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers ^[36]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Seven Days post each dose (D7)

Notes
[36] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	37	42	43	43	37	44
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD4 all doubles, D7	499 (250 to 1267)	593.5 (269 to 1094)	128 (83 to 379)	174 (67 to 321)	55 (33 to 81)	52.5 (33 to 85)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	24 (1 to 83)	42.5 (14 to 66)	1 (1 to 39)	16 (1 to 43)	1 (1 to 15)	1 (1 to 19)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7	47 (15 to 143)	61.5 (18 to 157)	12 (1 to 25)	12 (1 to 29)	1 (1 to 12)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7	25 (1 to 103)	19.5 (1 to 71)	1 (1 to 26)	13 (1 to 38)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7	65 (12 to 286)	82.5 (29 to 320)	24 (1 to 52)	14 (1 to 44)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7	1 (1 to 15)	1 (1 to 22)	1 (1 to 1)	1 (1 to 12)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7	1 (1 to 32)	11 (1 to 38)	1 (1 to 11)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7	19 (9 to 61)	36.5 (1 to 105)	1 (1 to 19)	13 (1 to 49)	1 (1 to 1)	1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7	52 (1 to 144)	112 (25 to 297)	24 (1 to 102)	21 (1 to 58)	9 (1 to 63)	1 (1 to 37)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	12 (1 to 32)	14.5 (1 to 45)	1 (1 to 24)	1 (1 to 21)	1 (1 to 12)	11.5 (1 to 15.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7	64 (12 to 107)	35.5 (1 to 88)	3 (1 to 24)	1 (1 to 13)	1 (1 to 13)	1 (1 to 7.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7	173 (38 to 232)	102 (31 to 237)	22 (1 to 86)	22 (1 to 67)	1 (1 to 1)	1 (1 to 14.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7	576 (245 to 1126)	493 (309 to 960)	138 (42 to 208)	26 (1 to 134)	1 (1 to 45)	1 (1 to 42.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7	1 (1 to 18)	1 (1 to 36)	1 (1 to 11)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7	25 (10 to 58)	27.5 (5 to 85)	1 (1 to 28)	1 (1 to 20)	11 (1 to 21)	1 (1 to 13.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7	232 (85 to 444)	160.5 (61 to 314)	30 (5 to 69)	40 (12 to 91)	1 (1 to 17)	14 (1 to 44.5)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers ^[37]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

One Month post each dose (M1)

Notes
[37] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	41	43	44	41	34	42
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD4 all doubles, M1	640 (403 to 1200)	859 (348 to 1950)	173.5 (93.5 to 476)	235 (142 to 485)	31 (22 to 66)	55.5 (30 to 115)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	52 (1 to 157)	50 (12 to 253)	17 (1 to 63)	25 (1 to 88)	1 (1 to 12)	12 (1 to 26)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1	142 (48 to 300)	195 (66 to 408)	30 (11.5 to 82.5)	56 (14 to 88)	1 (1 to 12)	1 (1 to 17)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1	14 (1 to 45)	24 (1 to 132)	1 (1 to 14)	12 (1 to 26)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1	109 (49 to 143)	138 (56 to 327)	27 (1 to 59)	28 (12 to 63)	1 (1 to 1)	1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1	1 (1 to 19)	17 (1 to 37)	1 (1 to 1)	1 (1 to 12)	1 (1 to 1)	1 (1 to 11)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1	15 (1 to 44)	14 (1 to 63)	1 (1 to 6)	1 (1 to 1)	1 (1 to 1)	1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1	14 (1 to 41)	24 (1 to 64)	1 (1 to 12)	12 (1 to 24)	1 (1 to 1)	1 (1 to 14)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1	51 (1 to 107)	51 (1 to 162)	1 (1 to 50.5)	16 (1 to 96)	1 (1 to 42)	1 (1 to 42)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	28 (1 to 109)	20 (1 to 60)	1 (1 to 45)	12 (1 to 24)	1 (1 to 1)	1 (1 to 15)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1	95 (32 to 251)	127 (63 to 257)	28 (1 to 59.5)	15 (1 to 78)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1	57 (26 to 204)	63 (27 to 118)	19 (1 to 76)	24 (1 to 44)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1	431 (239 to 838)	449 (253 to 793)	115.5 (42.5 to 277.5)	127 (36 to 257)	3 (1 to 33)	23 (1 to 66)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1	1 (1 to 27)	1 (1 to 29)	1 (1 to 7)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1	53 (5 to 106)	51 (3 to 108)	9.5 (1 to 38)	19 (1 to 58)	1 (1 to 15)	11 (1 to 35)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1	54 (18 to 107)	71 (25 to 141)	19.5 (1 to 49)	11 (1 to 48)	1 (1 to 14)	1 (1 to 21)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers ^[38]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Six Months post each dose (M6)

Notes
[38] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	36	40	42	43	34	44
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD4 all doubles, M6	633 (324 to 1062)	512 (318.5 to 992.5)	107.5 (47 to 184)	107 (72 to 191)	39 (23 to 71)	41 (23 to 73.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	63 (18.5 to 129)	65 (13 to 125)	12 (1 to 28)	16 (1 to 48)	1 (1 to 13)	1 (1 to 13.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6	223 (78 to 403)	202.5 (101.5 to 434)	28 (1 to 50)	17 (1 to 64)	1 (1 to 15)	1 (1 to 12.5)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6	18.5 (1 to 25.5)	15.5 (1 to 29)	1 (1 to 1)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6	68.5 (40.5 to 163)	65 (34.5 to 184.5)	1 (1 to 22)	13 (1 to 41)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6	1 (1 to 1)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6	12 (1 to 20.5)	1 (1 to 26)	1 (1 to 11)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6	1 (1 to 6.5)	1 (1 to 28)	1 (1 to 1)	1 (1 to 1)	1 (1 to 11)	1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6	16.5 (1 to 71)	40.5 (1 to 95.5)	1 (1 to 28)	2 (1 to 44)	1 (1 to 39)	13.5 (1 to 48.5)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	13.5 (1 to 59.5)	13 (1 to 52.5)	1 (1 to 14)	1 (1 to 17)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6	72 (38 to 206.5)	86.5 (27 to 156.5)	12 (1 to 28)	5 (1 to 40)	1 (1 to 13)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6	31 (1 to 84.5)	26 (7 to 55)	1 (1 to 13)	1 (1 to 16)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6	310.5 (60 to 591.5)	171.5 (126.5 to 369)	35.5 (1 to 68)	48 (8 to 99)	10 (1 to 27)	12.5 (1 to 41)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6	1 (1 to 18)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6	19 (1 to 71.5)	27 (1 to 61)	1 (1 to 12)	1 (1 to 14)	1 (1 to 14)	1 (1 to 13.5)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6	19.5 (1 to 58)	14 (1 to 46.5)	1 (1 to 14)	1 (1 to 16)	1 (1 to 18)	1 (1 to 14)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers ^[39]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Twelve Months post each dose (M12)

Notes
[39] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	38	41	45	41	33	43
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD4 all doubles, M12	456.5 (237 to 1062)	403 (245 to 745)	104 (59 to 201)	98 (52 to 157)	38 (22 to 61)	41 (22 to 79)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	51 (18 to 145)	65 (18 to 99)	16 (1 to 42)	14 (1 to 48)	1 (1 to 1)	1 (1 to 14)
CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12	176 (73 to 424)	144 (80 to 329)	28 (12 to 52)	26 (13 to 47)	1 (1 to 14)	1 (1 to 12)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12	7 (1 to 39)	13 (1 to 40)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12	56.5 (24 to 145)	67 (24 to 149)	13 (1 to 21)	1 (1 to 16)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12	1 (1 to 13)	1 (1 to 13)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12	12.5 (1 to 37)	1 (1 to 23)	1 (1 to 1)	1 (1 to 13)	1 (1 to 1)	1 (1 to 12)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12	1 (1 to 12)	1 (1 to 17)	1 (1 to 13)	1 (1 to 1)	1 (1 to 12)	1 (1 to 13)
CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12	10.5 (1 to 57)	29 (1 to 81)	1 (1 to 48)	14 (1 to 67)	22 (1 to 58)	13 (1 to 72)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	13 (1 to 29)	1 (1 to 17)	1 (1 to 16)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12	60 (15 to 138)	39 (13 to 91)	12 (1 to 21)	1 (1 to 12)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12	21 (1 to 56)	19 (1 to 40)	1 (1 to 12)	1 (1 to 12)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12	179 (84 to 283)	155 (74 to 300)	30 (1 to 66)	50 (22 to 87)	1 (1 to 20)	3 (1 to 25)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12	1 (1 to 15)	1 (1 to 12)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12	3.5 (1 to 38)	1 (1 to 35)	3 (1 to 40)	1 (1 to 39)	1 (1 to 27)	1 (1 to 19)
CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12	14.5 (1 to 49)	2 (1 to 54)	1 (1 to 25)	1 (1 to 25)	1 (1 to 27)	1 (1 to 41)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers ^[40]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Before vaccination (PRE)

Notes
[40] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	37	36	42	39	34	39
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD8 all doubles, PRE	11 (11 to 81)	40.5 (11 to 70.5)	11 (11 to 61)	11 (11 to 93)	11 (11 to 65)	11 (11 to 47)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE	1 (1 to 44)	1 (1 to 42)	1 (1 to 53)	1 (1 to 46)	1 (1 to 50)	1 (1 to 55)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE	8 (1 to 116)	117 (40 to 260)	57 (1 to 138)	61 (1 to 166)	53.5 (1 to 91)	65 (1 to 302)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE	1 (1 to 64)	1 (1 to 14.5)	1 (1 to 1)	1 (1 to 1)	1 (1 to 28)	1 (1 to 27)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE	1 (1 to 40)	1 (1 to 1)	1 (1 to 23)	1 (1 to 1)	1 (1 to 2)	1 (1 to 43)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

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End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers ^[41]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Seven Days after each dose (D7)

Notes
[41] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	37	42	43	43	37	44
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD8 all doubles, D7	61 (11 to 147)	55 (11 to 161)	43 (11 to 101)	46 (11 to 82)	11 (11 to 11)	11 (11 to 28)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7	1 (1 to 1)	1 (1 to 31)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7	34 (1 to 104)	37 (1 to 119)	6 (1 to 116)	1 (1 to 100)	3 (1 to 54)	1 (1 to 25)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7	61 (1 to 185)	161.5 (1 to 574)	1 (1 to 107)	34 (1 to 303)	1 (1 to 61)	123 (1 to 289.5)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7	6 (1 to 64)	7.5 (1 to 72)	1 (1 to 67)	1 (1 to 10)	1 (1 to 85)	1 (1 to 48)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7	37 (1 to 89)	1 (1 to 50)	1 (1 to 70)	1 (1 to 31)	1 (1 to 30)	1 (1 to 2.5)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers ^[42]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

One Month after each dose (M1)

Notes
[42] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	41	43	44	41	34	42
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD8 all doubles, M1	69 (11 to 145)	82 (11 to 163)	29.5 (11 to 80)	81 (26 to 139)	11 (11 to 28)	11 (11 to 53)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1	1 (1 to 1)	1 (1 to 32)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1	1 (1 to 1)	1 (1 to 32)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 56)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1	1 (1 to 55)	1 (1 to 46)	1 (1 to 52)	11 (1 to 99)	2.5 (1 to 85)	4 (1 to 109)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1	1 (1 to 12)	1 (1 to 28)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1	1 (1 to 139)	142 (1 to 308)	2.5 (1 to 116)	109 (2 to 218)	1 (1 to 48)	86 (1 to 330)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1	18 (1 to 87)	12 (1 to 111)	1 (1 to 50)	1 (1 to 90)	1 (1 to 51)	1 (1 to 35)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1	1 (1 to 65)	1 (1 to 65)	1 (1 to 5.5)	1 (1 to 64)	1 (1 to 5)	1 (1 to 1)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers ^[43]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Six Months after each dose (M6)

Notes
[43] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	36	40	42	43	34	44
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD8 all doubles, M6	11 (11 to 53)	11 (11 to 20)	11 (11 to 32)	11 (11 to 11)	11 (11 to 29)	11 (11 to 11)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6	1 (1 to 25.5)	2 (1 to 65)	1 (1 to 44)	1 (1 to 63)	1 (1 to 52)	2 (1 to 59)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6	1 (1 to 29.5)	27.5 (1 to 60)	38 (1 to 91)	1 (1 to 56)	28 (1 to 67)	1 (1 to 43.5)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6	1 (1 to 54.5)	1 (1 to 55.5)	1 (1 to 3)	1 (1 to 60)	1 (1 to 36)	1 (1 to 49)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6	1 (1 to 33)	1 (1 to 36.5)	1 (1 to 1)	1 (1 to 40)	1 (1 to 1)	1 (1 to 1)

No statistical analyses for this end point

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Top of page

End point title

Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers ^[44]

End point description

Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).

End point type

Secondary

End point timeframe

Twelve Months after each dose (M12)

Notes
[44] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	38	41	45	41	33	43
Units: T cells/million cells
median (inter-quartile range (Q1-Q3))
CD8 all doubles, M12	11 (11 to 52)	11 (11 to 35)	11 (11 to 38)	11 (11 to 41)	11 (11 to 41)	11 (11 to 42)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12	1 (1 to 29)	1 (1 to 64)	1 (1 to 68)	1 (1 to 35)	1 (1 to 32)	1 (1 to 40)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12	14.5 (1 to 92)	16 (1 to 77)	1 (1 to 59)	1 (1 to 35)	1 (1 to 57)	15 (1 to 66)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 1)	1 (1 to 5)	1 (1 to 1)
CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12	1 (1 to 34)	1 (1 to 50)	1 (1 to 58)	1 (1 to 65)	1 (1 to 117)	1 (1 to 22)
CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12	1.5 (1 to 67)	1 (1 to 48)	1 (1 to 25)	1 (1 to 128)	11 (1 to 57)	1 (1 to 33)

No statistical analyses for this end point

Secondary: Number of seropositive subjects against M72 antigen

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End point title

Number of seropositive subjects against M72 antigen ^[45]

End point description

A seropositive subject was a subject whose M72 antibody concentration was greater than or equal to 2.8 ELISA units per millilitre (EL.U/mL).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]

Notes
[45] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	43	44	48	46	39	46
Units: Subjects
Anti-M72, PRE (N=43;44;48;46;39;46)	0	0	0	0	1	0
Anti-M72, M1 (N=42;43;45;44;34;43)	42	43	39	39	1	0
Anti-M72, M6 (N=40;41;45;45;36;45)	40	41	32	35	0	1
Anti-M72, M12 (N=41;42;47;45;35;43)	41	42	35	31	1	2

No statistical analyses for this end point

Secondary: Concentration of antibodies against M72 antigen

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End point title

Concentration of antibodies against M72 antigen ^[46]

End point description

Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]

Notes
[46] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	43	44	48	46	39	46
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-M72, PRE (N=43;44;48;46;39;46)	1.4 (1.4 to 1.4)	1.4 (1.4 to 1.4)	1.4 (1.4 to 1.4)	1.4 (1.4 to 1.4)	1.5 (1.3 to 1.7)	1.4 (1.4 to 1.4)
Anti-M72, M1 (N=42;43;45;44;34;43)	1275.2 (981.3 to 1657.2)	1264 (928 to 1721.5)	8 (6 to 10.7)	7.4 (5.3 to 10.2)	1.5 (1.3 to 1.7)	1.4 (1.4 to 1.4)
Anti-M72, M6 (N=40;41;45;45;36;45)	98.9 (75.2 to 130.1)	102.6 (78.7 to 133.9)	4.6 (3.4 to 6.2)	4.9 (3.8 to 6.4)	1.4 (1.4 to 1.4)	1.4 (1.4 to 1.5)
Anti-M72, M12 (N=41;42;47;45;35;43)	68.3 (50.7 to 92)	76 (56.6 to 102)	5.3 (3.9 to 7)	4.3 (3.2 to 5.8)	1.4 (1.4 to 1.5)	1.5 (1.4 to 1.7)

No statistical analyses for this end point

Secondary: Number of seroprotected subjects against diphtheria toxoid (Anti-D) and tetanus toxoid (Anti-T)

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End point title

Number of seroprotected subjects against diphtheria toxoid (Anti-D) and tetanus toxoid (Anti-T)

End point description

A seroprotected subject was a subject whose anti-diphtheria toxoid (anti-D)/anti-tetanus toxoid (anti-T) antibody concentration was greater than or equal to (≥) 0.1 international-units per millilitre (IU/mL).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	43	43	43
Units: Subjects
Anti-D, PRE (N=37,38,38)	6	10	6
Anti-D,PIII(M3) (N=43,43,43)	43	43	43
Anti-T, PRE(N=37,38,38)	32	35	35
Anti-T,PIII(M3) (N=43,43,43)	43	43	43

No statistical analyses for this end point

Secondary: Anti-D, Anti-T antibody concentrations

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End point title

Anti-D, Anti-T antibody concentrations

End point description

Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	43	43	43
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-D, PRE (N=37,38,38)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)
Anti-D,PIII(M3) (N=43,43,43)	2.1 (1.6 to 2.7)	2.4 (1.8 to 3.1)	2.5 (2 to 3.1)
Anti-T, PRE(N=37,38,38)	0.6 (0.4 to 1)	1 (0.6 to 1.5)	1 (0.6 to 1.6)
Anti-T,PIII(M3) (N=43,43,43)	5.5 (4.3 to 7.1)	4.8 (3.6 to 6.4)	6.3 (4.8 to 8.3)

No statistical analyses for this end point

Secondary: Number of seroprotected subjects against Haemophilus influenza Type B (Anti-PRP)

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End point title

Number of seroprotected subjects against Haemophilus influenza Type B (Anti-PRP)

End point description

A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per millilitre (µg/mL).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	47	46	48
Units: Subjects
Anti-PRP, PRE (N=47,46,48)	8	14	12
Anti-PRP,PIII(M3) (N=44,44,43)	44	44	43

No statistical analyses for this end point

Secondary: Anti-PRP antibody concentrations

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End point title

Anti-PRP antibody concentrations

End point description

Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	47	46	48
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PRP, PRE (N=47,46,48)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.2)	0.1 (0.1 to 0.2)
Anti-PRP,PIII(M3) (N=44,44,43)	28.2 (20.3 to 39.1)	30.3 (21.8 to 42.1)	31.2 (21.8 to 44.7)

No statistical analyses for this end point

Secondary: Number of seropositive subjects against Bordetella Pertussis (Anti-BPT)

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End point title

Number of seropositive subjects against Bordetella Pertussis (Anti-BPT)

End point description

A seropositive subject was a subject whose anti-BPT antibody concentration was ≥ 15 EL.U/mL.

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	43	43
Units: Subjects
Anti-BPT, PRE (N=41,40,43)	1	1	1
Anti-BPT,PIII(M3) (N=44,43,43)	44	43	43

No statistical analyses for this end point

Secondary: Anti-BPT antibody concentrations

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End point title

Anti-BPT antibody concentrations

End point description

Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	43	43
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-BPT, PRE (N=41,40,43)	7.7 (7.3 to 8)	7.6 (7.4 to 7.9)	7.6 (7.4 to 7.9)
Anti-BPT,PIII(M3) (N=44,43,43)	139.4 (117.7 to 164.9)	132.1 (116.6 to 149.5)	131.5 (113.5 to 152.5)

No statistical analyses for this end point

Secondary: Number of seropositive subjects against Hepatitis B (Anti-HB)

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End point title

Number of seropositive subjects against Hepatitis B (Anti-HB)

End point description

A seropositive subject was a subject whose anti-HB antibody concentration was ≥ 10 milli-international units per millilitre (mIU/mL).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: Subjects
Anti-HB, PRE (N=41,40,41)	9	14	13
Anti-HB, PIII(M3) (N=44,44,43)	42	43	42

No statistical analyses for this end point

Secondary: Number of seropositive subjects against Hepatitis B (Anti-HB) with antibody concentrations ≥100mIU/mL

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End point title

Number of seropositive subjects against Hepatitis B (Anti-HB) with antibody concentrations ≥100mIU/mL

End point description

A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Following from this, the table shows data with titers ≥ 100 mIU/mL.

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: Subjects
Anti-HB, PRE (N=41,40,41)	2	2	2
Anti-HB,PIII(M3) (N=44,44,43)	42	42	42

No statistical analyses for this end point

Secondary: Anti-HB antibody concentrations

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End point title

Anti-HB antibody concentrations

End point description

Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: mIU/mL
geometric mean (confidence interval 95%)
Anti-HB, PRE (N=41,40,41)	8.3 (6 to 11.4)	10 (7.1 to 14)	9 (6.7 to 12.2)
Anti-HB,PIII(M3) (N=44,44,43)	1725.5 (1045 to 2849)	1471.8 (947.5 to 2286)	2153 (1468.2 to 3157.4)

No statistical analyses for this end point

Secondary: Number of seropositive subjects against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)

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End point title

Number of seropositive subjects against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)

End point description

A seropositive subject was a subject whose anti-polio antibody titer was ≥ 1:8.

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	46	45	48
Units: Subjects
Anti-Polio1, PRE (N=46,45,48)	36	38	39
Anti-Polio1, PIII(M3) (N=44,44,43)	41	43	42
Anti-Polio2,PRE (N=46,45,48)	33	32	38
Anti-Polio2,PIII(M3) (N=44,44,43)	43	42	42
Anti-Polio3,PRE (N=46,45,48)	21	18	14
Anti-Polio3,PIII(M3) (N=44,44,43)	42	38	39

No statistical analyses for this end point

Secondary: Anti-Polio1, Anti-Polio2, Anti-Polio3 antibody titers

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End point title

Anti-Polio1, Anti-Polio2, Anti-Polio3 antibody titers

End point description

Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	46	45	48
Units: Titer
geometric mean (confidence interval 95%)
Anti-Polio1, PRE (N=46,45,48)	56.3 (30.7 to 103.2)	48.8 (27.3 to 87.5)	103.8 (58.1 to 185.3)
Anti-Polio1, PIII(M3) (N=44,44,43)	299.9 (167.6 to 536.7)	397.8 (240.2 to 658.8)	573.1 (368.7 to 890.6)
Anti-Polio2,PRE (N=46,45,48)	51.8 (28.8 to 93.2)	53.2 (28 to 101)	61.2 (34.8 to 107.8)
Anti-Polio2,PIII(M3) (N=44,44,43)	458.7 (307.7 to 683.7)	524.3 (331.1 to 830.3)	499.9 (317.7 to 786.5)
Anti-Polio3,PRE (N=46,45,48)	15.2 (9 to 25.6)	15.4 (8.6 to 27.6)	10.9 (6.7 to 17.9)
Anti-Polio3,PIII(M3) (N=44,44,43)	154.8 (100.8 to 237.8)	103.5 (59.7 to 179.6)	123 (73.6 to 205.8)

No statistical analyses for this end point

Secondary: Number of seropositive subjects against Streptococcus pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)

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End point title

Number of seropositive subjects against Streptococcus pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)

End point description

A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL.

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: Subjects
Anti-4, PRE (N=39,39,40)	18	21	12
Anti-4, PIII(M3) (N=43,43,43)	43	43	43
Anti-6B,PRE (N=38,39,40)	29	27	26
Anti-6B,PIII(M3) (N=44,43,43)	44	41	40
Anti-9V,PRE (N=37,39,39)	28	33	25
Anti-9V,PIII(M3) (N=43,43,43)	43	43	43
Anti-14,PRE (N=39,38,40)	39	38	38
Anti-14,PIII(M3) (N=44,44,43)	44	44	43
Anti-18C, PRE (N=42,40,42)	30	35	26
Anti-18C, PIII(M3) (N=43,44,43)	43	44	43
Anti-19F, PRE (N=37,38,40)	35	37	39
Anti-19F, PIII(M3) (N=44,44,43)	44	44	43
Anti-23F,PRE (N=41,40,42)	25	30	26
Anti-23F, PIII(M3) (N=44,43,43)	43	43	42

No statistical analyses for this end point

Secondary: Number of subjects with S. pneumoniae antibody concentrations ≥ 0.2 µg/mL

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End point title

Number of subjects with S. pneumoniae antibody concentrations ≥ 0.2 µg/mL

End point description

A seroconverted subject is a vaccinated subject with at least a four fold increased antibody titer post vaccination.

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: Subjects
Anti-4, PRE (N=39,39,40)	5	10	2
Anti-4, PIII(M3) (N=43,43,43)	43	43	43
Anti-6B,PRE (N=38,39,40)	8	5	6
Anti-6B,PIII(M3) (N=44,43,43)	38	40	35
Anti-9V,PRE (N=37,39,39)	18	20	10
Anti-9V,PIII(M3) (N=43,43,43)	43	43	43
Anti-14,PRE (N=39,38,40)	34	33	33
Anti-14,PIII(M3) (N=44,44,43)	44	43	43
Anti-18C, PRE (N=42,40,42)	10	17	9
Anti-18C, PIII(M3) (N=43,44,43)	43	43	42
Anti-19F, PRE (N=37,38,40)	30	30	26
Anti-19F, PIII(M3) (N=44,44,43)	43	44	43
Anti-23F,PRE (N=41,40,42)	9	11	14
Anti-23F, PIII(M3) (N=44,43,43)	42	41	42

No statistical analyses for this end point

Secondary: Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F antibody concentrations

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End point title

Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F antibody concentrations

End point description

Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).

End point type

Secondary

End point timeframe

Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	44	44	43
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-4, PRE (N=39,39,40)	0.1 (0 to 0.1)	0.1 (0.1 to 0.1)	0 (0 to 0)
Anti-4, PIII(M3) (N=43,43,43)	7.7 (6.2 to 9.7)	6.4 (5.3 to 7.8)	8.1 (6.5 to 10)
Anti-6B,PRE (N=38,39,40)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)
Anti-6B,PIII(M3) (N=44,43,43)	2.3 (1.4 to 3.8)	1.5 (0.9 to 2.4)	1.5 (0.8 to 2.7)
Anti-9V,PRE (N=37,39,39)	0.1 (0.1 to 0.1)	0.2 (0.1 to 0.3)	0.1 (0.1 to 0.1)
Anti-9V,PIII(M3) (N=43,43,43)	5.8 (4.4 to 7.7)	4.1 (3 to 5.6)	6 (4.5 to 8.1)
Anti-14,PRE (N=39,38,40)	0.8 (0.6 to 1.2)	1.1 (0.7 to 1.6)	0.7 (0.4 to 1)
Anti-14,PIII(M3) (N=44,44,43)	3.6 (2.5 to 5.3)	3.3 (2.3 to 4.7)	4.2 (2.8 to 6.2)
Anti-18C, PRE (N=42,40,42)	0.1 (0.1 to 0.1)	0.2 (0.1 to 0.2)	0.1 (0.1 to 0.1)
Anti-18C, PIII(M3) (N=43,44,43)	7.2 (5.7 to 9)	5.1 (3.8 to 7)	6.1 (4.2 to 8.8)
Anti-19F, PRE (N=37,38,40)	0.4 (0.3 to 0.6)	0.5 (0.3 to 0.7)	0.3 (0.2 to 0.5)
Anti-19F, PIII(M3) (N=44,44,43)	5.8 (4.1 to 8.2)	5.4 (4.2 to 6.9)	5.9 (4.5 to 7.5)
Anti-23F,PRE (N=41,40,42)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)
Anti-23F, PIII(M3) (N=44,43,43)	3.2 (2.1 to 4.8)	3 (2 to 4.6)	3.8 (2.5 to 5.7)

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) ^[47]

End point description

End point type

Secondary

End point timeframe

From Day 0 up to 12 months post last vaccination

Notes
[47] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	50	52	50	49
Units: Subjects
Any SAEs	2	1	3	1	3	1

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, grade 1 (G1), grade 2 (G2) or grade 4 (G4) Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, grade 1 (G1), grade 2 (G2) or grade 4 (G4) Haematological and Biochemical Markers ^[48]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, G1, G2 and G4 . Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Before vaccination (PRE)

Notes
[48] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692342 1 dose Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	50	52	50	49
Units: Subjects
Haem, PRE, Normal	49	48	50	51	48	49
Haem, PRE, G1	0	1	0	0	1	0
Haem, PRE, G2	1	0	0	1	0	0
Haem, PRE, G4	0	0	0	0	0	0
WBC, PRE, Normal	45	48	49	52	43	47
WBC, PRE, G1	0	0	0	0	0	0
WBC, PRE, G2	0	0	0	0	0	0
WBC, PRE, G4	0	0	0	0	0	0
PLA, PRE, Normal	48	49	49	52	48	49
PLA, PRE, G1	2	0	0	0	1	0
PLA, PRE, G2	0	0	0	0	0	0
PLA, PRE, G4	0	0	0	0	0	0
ALA, PRE, Normal	42	47	39	51	40	48
ALA, PRE, G1	0	1	0	0	0	1
ALA, PRE, G2	0	0	0	0	1	0
ALA, PRE, G4	0	0	0	0	0	0
CREA PRE, Normal	42	48	39	51	41	49
CREA PRE, G1	0	0	0	0	0	0
CREA PRE, G2	0	0	0	0	0	0
CREA PRE, G4	0	0	0	0	0	0
Haem, PRE, Missing	0	0	0	0	1	0
WBC, PRE, Missing	5	1	1	0	7	2
PLA, PRE, Missing	0	0	0	0	1	0
ALA, PRE, Missing	8	1	11	1	9	0
CREA, PRE, Missing	8	1	11	1	9	0

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[49]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Seven days post Dose 1 [PI(D7)]

Notes
[49] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Haem, PI(D7), Normal	49	48	48
Haem, PI(D7), G1	0	0	0
Haem, PI(D7), G2	0	0	0
Haem, PI(D7), G4	0	0	0
WBC, PI(D7), Normal	46	47	45
WBC, PI(D7), G1	0	0	0
WBC, PI(D7), G2	0	0	0
WBC, PI(D7), G4	0	0	0
PLA, PI(D7), Normal	49	49	47
PLA, PI(D7), G1	0	1	1
PLA, PI(D7), G2	0	0	0
PLA, PI(D7), G4	0	0	0
ALA, PI(D7), Normal	48	48	48
ALA, PI(D7), G1	0	0	0
ALA, PI(D7), G2	0	0	0
ALA, PI(D7), G4	0	0	0
CREA PI(D7), Normal	48	48	49
CREA PI(D7), G1	0	0	0
CREA PI(D7), G2	0	0	0
CREA PI(D7), G4	0	0	0
Haem, PI(D7), Missing	1	2	0
WBC, PI(D7), Missing	4	3	5
PLA, PI(D7), Missing	0	0	1
ALA, PI(D7), Missing	2	2	2
CREA, PI(D7), Missing	2	2	1

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[50]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Seven days post Dose 2 [PII(D37)]

Notes
[50] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Menjugate Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	50	49	52	50	49
Units: Subjects
Haem, PII(D37), Normal	47	45	0	47	47
Haem, PII(D37), G1	1	0	0	1	0
Haem, PII(D37), G2	0	0	0	0	0
Haem, PII(D37), G4	0	0	0	0	0
WBC, PII(D37), Normal	42	44	0	44	44
WBC, PII(D37), G1	0	0	0	0	0
WBC, PII(D37), G2	0	0	0	0	0
WBC, PII(D37), G4	0	0	0	0	0
PLA, PII(D37), Normal	47	45	0	48	47
PLA, PII(D37), G1	1	0	0	0	0
PLA, PII(D37), G2	0	0	0	0	0
PLA, PII(D37), G4	0	0	0	0	0
ALA, PII(D37), Normal	48	46	0	48	47
ALA, PII(D37), G1	0	0	0	0	0
ALA, PII(D37), G2	0	0	0	0	0
ALA, PII(D37), G4	0	0	0	0	0
CREA PII(D37), Normal	48	46	0	48	47
CREA PII(D37), G1	0	0	0	0	0
CREA PII(D37), G2	0	0	0	0	0
CREA PII(D37), G4	0	0	0	0	0
Haem, PII(D36), Missing	2	4	52	2	2
WBC, PII(D36), Missing	8	5	52	6	5
PLA, PII(D36), Missing	2	4	52	2	2
ALA, PII(D36), Missing	2	3	52	2	2
CREA, PII(D36), Missing	2	3	52	2	2

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Seven days post Dose 3 [PIII(D67)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(D67), Normal	46	51	46
Haem, PIII(D67), G1	0	0	0
Haem, PIII(D67), G2	0	0	0
Haem, PIII(D67), G4	0	0	0
WBC, PIII(D67), Normal	44	49	46
WBC, PIII(D67), G1	0	0	0
WBC, PIII(D67), G2	0	0	0
WBC, PIII(D67), G4	0	0	0
PLA, PIII(D67), Normal	46	51	46
PLA, PIII(D67), G1	0	0	0
PLA, PIII(D67), G2	0	0	0
PLA, PIII(D67), G4	0	0	0
ALA, PIII(D67), Normal	46	51	45
ALA, PIII(D67), G1	0	1	0
ALA, PIII(D67), G2	0	0	0
ALA, PIII(D67), G4	0	0	0
CREA PIII(D67), Normal	46	52	45
CREA PIII(D67), G1	0	0	0
CREA PIII(D67), G2	0	0	0
CREA PIII(D67), G4	0	0	0
Haem, PIII(D67), Missing	3	1	3
WBC, PIII(D67), Missing	5	3	3
PLA, PIII(D67), Missing	3	1	3
ALA, PIII(D67), Missing	3	0	4
CREA, PIII(D67), Missing	3	0	4

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[51]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

One Month post Dose 1 [PI(M1)]

Notes
[51] - 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 SB692342 2 dose Group, the SB692342 1 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	SB692342 1 dose Group	Control Menjugate Group
Number of subjects analysed	50	50	50
Units: Subjects
Haem, PI(M1), Normal	0	45	0
Haem, PI(M1), G1	0	2	0
Haem, PI(M1), G2	0	0	0
Haem, PI(M1), G4	0	0	0
WBC, PI(M1), Normal	0	46	0
WBC, PI(M1), G1	0	0	0
WBC, PI(M1), G2	0	0	0
WBC, PI(M1), G4	0	0	0
PLA, PI(M1), Normal	0	47	0
PLA, PI(M1), G1	0	0	0
PLA, PI(M1), G2	0	0	0
PLA, PI(M1), G4	0	0	0
ALA, PI(M1), Normal	0	42	0
ALA, PI(M1), G1	0	0	0
ALA, PI(M1), G2	0	0	0
ALA, PI(M1), G4	0	0	0
CREA PI(M1), Normal	0	42	0
CREA PI(M1), G1	0	0	0
CREA PI(M1), G2	0	0	0
CREA PI(M1), G4	0	0	0
Haem, PI(M1), Missing	50	3	50
WBC, PI(M1), Missing	50	4	50
PLA, PI(M1), Missing	50	3	50
ALA, PI(M1), Missing	50	8	50
CREA, PI(M1), Missing	50	8	50

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[52]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

One Month post Dose 2 [PII(M2)]

Notes
[52] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M2), Normal	47	44
Haem, PII(M2), G1	0	0
Haem, PII(M2), G2	0	0
Haem, PII(M2), G4	0	0
WBC, PII(M2), Normal	45	41
WBC, PII(M2), G1	0	0
WBC, PII(M2), G2	0	0
WBC, PII(M2), G4	0	0
PLA, PII(M2), Normal	47	44
PLA, PII(M2), G1	0	0
PLA, PII(M2), G2	0	0
PLA, PII(M2), G4	0	0
ALA, PII(M2), Normal	42	36
ALA, PII(M2), G1	0	0
ALA, PII(M2), G2	0	0
ALA, PII(M2), G4	0	0
CREA PII(M2), Normal	42	36
CREA PII(M2), G1	0	0
CREA PII(M2), G2	0	0
CREA PII(M2), G4	0	0
Haem, PII(M2), Missing	3	6
WBC, PII(M2), Missing	5	9
PLA, PII(M2), Missing	3	6
ALA, PII(M2), Missing	8	14
CREA, PII(M2), Missing	8	14

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

One Month post Dose 3 [PIII(M3)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(M3), Normal	46	49	44
Haem, PIII(M3), G1	0	0	0
Haem, PIII(M3), G2	0	0	0
Haem, PIII(M3), G4	0	0	0
WBC, PIII(M3), Normal	45	48	43
WBC, PIII(M3), G1	0	0	0
WBC, PIII(M3), G2	0	0	0
WBC, PIII(M3), G4	0	0	0
PLA, PIII(M3), Normal	46	48	44
PLA, PIII(M3), G1	0	0	0
PLA, PIII(M3), G2	0	0	0
PLA, PIII(M3), G4	0	0	0
ALA, PIII(M3), Normal	46	50	44
ALA, PIII(M3), G1	0	0	0
ALA, PIII(M3), G2	0	0	0
ALA, PIII(M3), G4	0	0	0
CREA PIII(M3), Normal	46	50	44
CREA PIII(M3), G1	0	0	0
CREA PIII(M3), G2	0	0	0
CREA PIII(M3), G4	0	0	0
Haem, PIII(M3), Missing	3	3	5
WBC, PIII(M3), Missing	4	4	6
PLA, PIII(M3), Missing	3	3	5
ALA, PIII(M3), Missing	3	2	5
CREA, PIII(M3), Missing	3	2	5

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[53]

End point description

End point type

Secondary

End point timeframe

Six Months post Dose 1 [PI(M6)]

Notes
[53] - 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 SB692342 1 dose Group from the baseline period.

End point values	SB692342 1 dose Group
Number of subjects analysed	50
Units: Subjects
Haem, PI(M6), Normal	41
Haem, PI(M6), G1	4
Haem, PI(M6), G2	1
Haem, PI(M6), G4	0
WBC, PI(M6), Normal	45
WBC, PI(M6), G1	0
WBC, PI(M6), G2	0
WBC, PI(M6), G4	0
PLA, PI(M6), Normal	46
PLA, PI(M6), G1	0
PLA, PI(M6), G2	0
PLA, PI(M6), G4	0
ALA, PI(M6), Normal	45
ALA, PI(M6), G1	1
ALA, PI(M6), G2	0
ALA, PI(M6), G4	0
CREA PI(M6), Normal	46
CREA PI(M6), G1	0
CREA PI(M6), G2	0
CREA PI(M6), G4	0
Haem, PI(M6), Missing	4
WBC, PI(M6), Missing	5
PLA, PI(M6), Missing	4
ALA, PI(M6), Missing	4
CREA, PI(M6), Missing	4

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[54]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Six Months post Dose 2 [PII(M7)]

Notes
[54] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M7), Normal	42	41
Haem, PII(M7), G1	3	3
Haem, PII(M7),G2	0	0
Haem, PII(M7),G4	0	0
WBC, PII(M7), Normal	42	44
WBC, PII(M7), G1	0	0
WBC, PII(M7), G2	0	0
WBC, PII(M7), G4	0	0
PLA, PII(M7), Normal	45	44
PLA, PII(M7), G1	0	0
PLA, PII(M7), G2	0	0
PLA, PII(M7), G4	0	0
ALA, PII(M7), Normal	43	43
ALA, PII(M7), G1	0	0
ALA, PII(M7), G2	0	0
ALA, PII(M7), G4	0	0
CREA PII(M7), Normal	43	43
CREA PII(M7), G1	0	0
CREA PII(M7), G2	0	0
CREA PII(M7), G4	0	0
Haem, PII(M7), Missing	5	6
WBC, PII(M7), Missing	8	6
PLA, PII(M7), Missing	5	6
ALA, PII(M7), Missing	7	7
CREA, PII(M7), Missing	7	7

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Six Months post Dose 3 [PIII(M8)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(M8), Normal	43	47	44
Haem, PIII(M8), G1	1	4	2
Haem, PIII(M8), G2	0	0	0
Haem, PIII(M8),G4	0	0	0
WBC, PIII(M8), Normal	41	47	41
WBC, PIII(M8), G1	0	0	0
WBC, PIII(M8), G2	0	0	0
WBC, PIII(M8), G4	0	0	0
PLA, PIII(M8), Normal	44	50	46
PLA, PIII(M8), G1	0	1	0
PLA, PIII(M8), G2	0	0	0
PLA, PIII(M8), G4	0	0	0
ALA, PIII(M8), Normal	43	50	46
ALA, PIII(M8), G1	1	0	0
ALA, PIII(M8), G2	0	0	0
ALA, PIII(M8), G4	0	0	0
CREA PIII(M8), Normal	43	51	46
CREA PIII(M8), G1	0	0	0
CREA PIII(M8), G2	0	0	0
CREA PIII(M8), G4	0	0	0
Haem, PIII(M8), Missing	5	1	3
WBC, PIII(M8), Missing	8	5	8
PLA, PIII(M8), Missing	5	1	3
ALA, PIII(M8), Missing	5	1	3
CREA, PIII(M8), Missing	6	1	3

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[55]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Six Months post Dose 3 [PIII(M13)]

Notes
[55] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PIII(M13), Normal	0	43
Haem, PIII(M13), G1	0	1
Haem, PIII(M13), G2	0	0
Haem, PIII(M13), G4	0	0
WBC, PIII(M13), Normal	0	42
WBC, PIII(M13), G1	0	0
WBC, PIII(M13), G2	0	0
WBC, PIII(M13), G4	0	0
PLA, PIII(M13), Normal	0	44
PLA, PIII(M13), G1	0	0
PLA, PIII(M13), G2	0	0
PLA, PIII(M13), G4	0	0
ALA, PIII(M13), Normal	0	44
ALA, PIII(M13), G1	0	0
ALA, PIII(M13), G2	0	0
ALA, PIII(M13), G4	0	0
CREA PIII(M13), Normal	0	44
CREA PIII(M13), G1	0	0
CREA PIII(M13), G2	0	0
CREA PIII(M13), G4	0	0
Haem, PIII(M13), Missing	50	6
WBC, PIII(M13), Missing	50	8
PLA, PIII(M13), Missing	50	6
ALA, PIII(M13), Missing	50	6
CREA, PIII(M13), Missing	50	6

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[56]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Twelve Months post Dose 1 [PI(M12)]

Notes
[56] - 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 SB692342 1 dose Group from the baseline period.

End point values	SB692342 1 dose Group
Number of subjects analysed	50
Units: Subjects
Haem, PI(M12), Normal	47
Haem, PI(M12), G1	2
Haem, PI(M12), G2	0
Haem, PI(M12), G4	0
WBC, PI(M12), Normal	48
WBC, PI(M12), G1	0
WBC, PI(M12), G2	0
WBC, PI(M12), G4	0
PLA, PI(M12), Normal	48
PLA, PI(M12), G1	1
PLA, PI(M12), G2	0
PLA, PI(M12), G4	0
ALA, PI(M12), Normal	46
ALA, PI(M12), G1	2
ALA, PI(M12), G2	1
ALA, PI(M12), G4	0
CREA PI(M12), Normal	49
CREA PI(M12), G1	0
CREA PI(M12), G2	0
CREA PI(M12), G4	0
Haem, PI(M12), Missing	1
WBC, PI(M12), Missing	2
PLA, PI(M12), Missing	1
ALA, PI(M12), Missing	1
CREA, PI(M12), Missing	1

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

Top of page

End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers ^[57]

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Twelve Months post Dose 2 [PII(M13)]

Notes
[57] - 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 SB692342 2 dose Group and the Control Menjugate Group from the baseline period.

End point values	SB692342 2 dose Group	Control Menjugate Group
Number of subjects analysed	50	50
Units: Subjects
Haem, PII(M13), Normal	41	0
Haem, PII(M13), G1	4	0
Haem, PII(M13), G2	1	0
Haem, PII(M13), G4	0	0
WBC, PII(M13), Normal	43	0
WBC, PII(M13), G1	0	0
WBC, PII(M13), G2	0	0
WBC, PII(M13), G4	0	0
PLA, PII(M13), Normal	46	0
PLA, PII(M13), G1	0	0
PLA, PII(M13), G2	0	0
PLA, PII(M13), G4	0	0
ALA, PII(M13), Normal	45	0
ALA, PII(M13), G1	1	0
ALA, PII(M13), G2	0	0
ALA, PII(M13), G4	0	0
CREA PII(M13), Normal	46	0
CREA PII(M13), G1	0	0
CREA PII(M13), G2	0	0
CREA PII(M13), G4	0	0
Haem, PII(M13), Missing	4	50
WBC, PII(M13), Missing	7	50
PLA, PII(M13), Missing	4	50
ALA, PII(M13), Missing	4	50
CREA, PII(M13), Missing	4	50

No statistical analyses for this end point

Secondary: Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

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End point title

Number of Subjects with Normal, G1, G2, or G4 Haematological and Biochemical Markers

End point description

Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.

End point type

Secondary

End point timeframe

Twelve Months post Dose 3 [PIII(M14)]

End point values	SB692392 2 dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Number of subjects analysed	49	52	49
Units: Subjects
Haem, PIII(M14), Normal	38	46	37
Haem, PIII(M14), G1	6	5	8
Haem, PIII(M14), G2	0	0	0
Haem, PIII(M14), G4	0	0	0
WBC, PIII(M14), Normal	42	48	42
WBC, PIII(M14), G1	0	0	0
WBC, PIII(M14), G2	0	0	0
WBC, PIII(M14), G4	0	0	0
PLA, PIII(M14), Normal	44	51	44
PLA, PIII(M14), G1	0	0	0
PLA, PIII(M14), G2	0	0	0
PLA, PIII(M14), G4	0	0	0
ALA, PIII(M14), Normal	43	51	43
ALA, PIII(M14), G1	1	0	1
ALA, PIII(M14), G2	0	0	0
ALA, PIII(M14), G4	0	0	0
CREA PIII(M14), Normal	44	51	44
CREA PIII(M14), G1	0	0	0
CREA PIII(M14), G2	0	0	0
CREA PIII(M14), G4	0	0	0
Haem, PIII(M14), Missing	5	1	4
WBC, PIII(M14), Missing	7	4	7
PLA, PIII(M14), Missing	5	1	4
ALA, PIII(M14), Missing	5	1	5
CREA, PIII(M14), Missing	5	1	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: from study start (Day 0) up to one month post-vaccination and from Day 0 up to 12 months post last vaccination.

Adverse event reporting additional description

Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

14.1

Reporting group title

SB692342 2 dose Group

Reporting group description

Reporting group title

SB692392 1 dose Group

Reporting group description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, at Month 0, after having completed their primary EPI regimen.

Reporting group title

Control Menjugate Group

Reporting group description

Reporting group title

SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Reporting group title

SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Subjects received one dose of SB692342 vaccine (0,5 mL), administered intramuscularly in the anterolateral region of the right thigh, concomitantly with the last dose of the primary EPI regimen containing Tritanrix HepB+Hiberix vaccine, administered intramuscularly in the anterolateral region of the left thigh, Polio Sabin™ vaccine, administered orally, and Prevnar vaccine, administered intramuscularly in the right arm, on a 0, 1, 2 months schedule. All subjects received a booster dose of the Tritanrix HepB+Hiberix, Polio Sabin and Prevnar vaccines approximately 1 year after their last dose.

Reporting group title

Control Tritanrix + Prevnar + Polio Sabin Group

Reporting group description

Serious adverse events	SB692342 2 dose Group	SB692392 1 dose Group	Control Menjugate Group	SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 50 (4.00%)	3 / 50 (6.00%)	3 / 50 (6.00%)	1 / 49 (2.04%)	1 / 52 (1.92%)	1 / 49 (2.04%)
number of deaths (all causes)	0	0	1	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Thermal burn
subjects affected / exposed	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (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
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 49 (0.00%)	1 / 52 (1.92%)	0 / 49 (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
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (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 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (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 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	1 / 49 (2.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	2 / 50 (4.00%)	1 / 50 (2.00%)	1 / 50 (2.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 50 (2.00%)	1 / 50 (2.00%)	0 / 50 (0.00%)	1 / 49 (2.04%)	0 / 52 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	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
Cerebral malaria
subjects affected / exposed	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (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 / 0	0 / 0	0 / 0	0 / 0
Malaria
subjects affected / exposed	1 / 50 (2.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 49 (0.00%)	0 / 52 (0.00%)	0 / 49 (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 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	SB692342 2 dose Group	SB692392 1 dose Group	Control Menjugate Group	SB692392 2dose + Tritanrix + Prevnar + Polio Sabin Group	SB692392 1 dose + Tritanrix + Prevnar + Polio Sabin Group	Control Tritanrix + Prevnar + Polio Sabin Group
Total subjects affected by non serious adverse events
subjects affected / exposed	33 / 50 (66.00%)	22 / 50 (44.00%)	31 / 50 (62.00%)	34 / 49 (69.39%)	22 / 52 (42.31%)	26 / 49 (53.06%)
General disorders and administration site conditions
Pyrexia
subjects affected / exposed ^[1]	3 / 50 (6.00%)	1 / 50 (2.00%)	4 / 50 (8.00%)	0 / 47 (0.00%)	2 / 52 (3.85%)	0 / 48 (0.00%)
occurrences all number	3	1	4	0	2	0
Pain
subjects affected / exposed ^[2]	6 / 50 (12.00%)	2 / 50 (4.00%)	6 / 50 (12.00%)	10 / 47 (21.28%)	13 / 52 (25.00%)	13 / 48 (27.08%)
occurrences all number	6	2	6	10	13	13
Swelling
subjects affected / exposed ^[3]	0 / 50 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)	6 / 47 (12.77%)	8 / 52 (15.38%)	8 / 48 (16.67%)
occurrences all number	0	0	0	6	8	8
Drowsiness
subjects affected / exposed ^[4]	2 / 50 (4.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	3 / 47 (6.38%)	3 / 52 (5.77%)	0 / 48 (0.00%)
occurrences all number	2	0	1	3	3	0
Irritability
subjects affected / exposed ^[5]	3 / 50 (6.00%)	0 / 50 (0.00%)	2 / 50 (4.00%)	8 / 47 (17.02%)	5 / 52 (9.62%)	4 / 48 (8.33%)
occurrences all number	3	0	2	8	5	4
Loss of appetite
subjects affected / exposed ^[6]	3 / 50 (6.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	3 / 47 (6.38%)	2 / 52 (3.85%)	0 / 48 (0.00%)
occurrences all number	3	0	1	3	2	0
Temperature(Axilarry)
subjects affected / exposed ^[7]	19 / 50 (38.00%)	5 / 50 (10.00%)	13 / 50 (26.00%)	18 / 47 (38.30%)	9 / 52 (17.31%)	12 / 48 (25.00%)
occurrences all number	19	5	13	18	9	12
Eye disorders
Conjunctivitis
subjects affected / exposed ^[8]	0 / 50 (0.00%)	0 / 50 (0.00%)	1 / 50 (2.00%)	0 / 47 (0.00%)	0 / 52 (0.00%)	3 / 48 (6.25%)
occurrences all number	0	0	1	0	0	3
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed ^[9]	8 / 50 (16.00%)	5 / 50 (10.00%)	2 / 50 (4.00%)	5 / 47 (10.64%)	1 / 52 (1.92%)	3 / 48 (6.25%)
occurrences all number	8	5	2	5	1	3
Infections and infestations
Respiratory tract infection
subjects affected / exposed ^[10]	21 / 50 (42.00%)	14 / 50 (28.00%)	19 / 50 (38.00%)	15 / 47 (31.91%)	9 / 52 (17.31%)	14 / 48 (29.17%)
occurrences all number	21	14	19	15	9	14

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.

More information

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Were there any global substantial amendments to the protocol? Yes

19 Nov 2010

The purpose of this amendment is to apply a standard and robust methodology for the collection, documentation and safety monitoring of serious and nonserious potential immune mediated disorders (pIMDs) as adverse events of special interest occurring in subjects participating in clinical trials evaluating GSK adjuvant containing vaccines. Guidance for what is considered as to be potentially immune mediated and time period of pIMD reporting are included in this amendment.

28 Jul 2011

The pneumococcal conjugate vaccine (PCV) being administered as part of the EPI vaccination in this study is Prevnar (7-valent PCV). The manufacturing company (Wyeth) has stopped production and marketing of 7-valent PCV which was initially used in the study. It currently produces and markets the 13-valent PCV (Prevnar 13). The SPC shows that the 13-valent PCV can be given after the 7-valent PCV with no safety issues. Hence for the booster dose, subjects in this study will be given the 13- valent PCV. This change in formulation of the administered vaccine is not expected to have an impact on the analysis of any study endpoints. The protocol has been amended to include a description of the 13-valent PCV.

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: Number of subjects with grade 3 solicited local symptoms after dose 1, dose 2 and across doses

Primary: Number of subjects with grade 3 solicited local symptoms after dose 1, dose 2 and across doses

Primary: Number of subjects with grade 3 solicited local symptoms after dose 2, dose 3 and across doses

Primary: Number of subjects with grade 3 solicited local symptoms after dose 2, dose 3 and across doses

Primary: Number of subjects with grade 3 solicited general symptoms after dose 1, dose 2 and across doses

Primary: Number of subjects with grade 3 solicited general symptoms after dose 1, dose 2 and across doses

Primary: Number of subjects with grade 3 solicited general symptoms after dose 2, dose 3 and across doses

Primary: Number of subjects with grade 3 solicited general symptoms after dose 2, dose 3 and across doses

Primary: Number of subjects with grade 3 unsolicited adverse events (AEs)

Primary: Number of subjects with grade 3 unsolicited adverse events (AEs)

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

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

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Primary: Number of subjects with grade 3 haematological and biochemical levels

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)4+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Frequency of M. tuberculosis fusion protein M72 (M72)-specific cluster of differentiation (CD)8+ T cells per million cells expressing at least two different immune markers

Secondary: Number of seropositive subjects against M72 antigen

Secondary: Number of seropositive subjects against M72 antigen

Secondary: Concentration of antibodies against M72 antigen

Secondary: Concentration of antibodies against M72 antigen

Secondary: Number of seroprotected subjects against diphtheria toxoid (Anti-D) and tetanus toxoid (Anti-T)

Secondary: Number of seroprotected subjects against diphtheria toxoid (Anti-D) and tetanus toxoid (Anti-T)

Secondary: Anti-D, Anti-T antibody concentrations

Secondary: Anti-D, Anti-T antibody concentrations

Secondary: Number of seroprotected subjects against Haemophilus influenza Type B (Anti-PRP)

Secondary: Number of seroprotected subjects against Haemophilus influenza Type B (Anti-PRP)

Secondary: Anti-PRP antibody concentrations