Trial Outcomes & Findings for Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants (NCT NCT01098474)

NCT ID: NCT01098474

Last Updated: 2019-06-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 301 participants
• Primary outcome timeframe: At Day 7
• Results posted on: 2019-06-27

Participant Flow

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

Participant milestones

Measure	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692342 2 Dose Group 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.	SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Active Phase STARTED	50	50	50	49	52	49
Active Phase COMPLETED	49	45	48	49	52	49
Active Phase NOT COMPLETED	1	5	2	0	0	0
Follow Up Phase STARTED	49	45	48	49	52	49
Follow Up Phase COMPLETED	49	45	48	47	50	44
Follow Up Phase NOT COMPLETED	0	0	0	2	2	5

Reasons for withdrawal

Measure	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692342 2 Dose Group 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.	SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Active Phase Other	0	3	0	0	0	0
Active Phase Withdrawal by Subject	1	2	1	0	0	0
Active Phase Lost to Follow-up	0	0	1	0	0	0
Follow Up Phase Travelled out of study area	0	0	0	0	1	0
Follow Up Phase Other	0	0	0	0	0	4
Follow Up Phase Withdrawal by Subject	0	0	0	2	0	1
Follow Up Phase Lost to Follow-up	0	0	0	0	1	0

Baseline Characteristics

Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

Baseline characteristics by cohort

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.	Total n=300 Participants Total of all reporting groups
Age, Continuous	5.8 Months STANDARD_DEVIATION 0.68 • n=5 Participants	5.7 Months STANDARD_DEVIATION 0.61 • n=7 Participants	5.7 Months STANDARD_DEVIATION 0.65 • n=5 Participants	2.1 Months STANDARD_DEVIATION 0.28 • n=4 Participants	2 Months STANDARD_DEVIATION 0.19 • n=21 Participants	2.1 Months STANDARD_DEVIATION 0.31 • n=10 Participants	3.9 Months STANDARD_DEVIATION 1.9 • n=115 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	25 Participants n=4 Participants	16 Participants n=21 Participants	23 Participants n=10 Participants	141 Participants n=115 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	24 Participants n=4 Participants	36 Participants n=21 Participants	26 Participants n=10 Participants	159 Participants n=115 Participants
Race/Ethnicity, Customized African heritage/African American	50 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	49 Participants n=4 Participants	52 Participants n=21 Participants	49 Participants n=10 Participants	300 Participants n=115 Participants

PRIMARY outcome

Timeframe: From Day 0 to Day 6

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Swelling, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Pain, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Swelling, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Pain, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses Grade 3 Pain, Across doses	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From Day 0 to Day 6

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=47 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Swelling, Dose 3	3 Participants	6 Participants	3 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Pain, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Swelling, Dose 2	2 Participants	0 Participants	2 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Pain, Dose 3	2 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Pain, Across doses	2 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Swelling, Across doses	3 Participants	6 Participants	5 Participants	—	—	—

PRIMARY outcome

Timeframe: From Day 0 to Day 6

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Drowsiness, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Irritability, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Loss of appetite, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Temperature /Axillary, Dose 1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Drowsiness, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Irritability, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Temperature/Axillary, Dose 2	0 Participants	0 Participants	1 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Drowsiness, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Irritability, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Loss of appetite, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses. Grade 3 Temperature/Axillary, Across doses	0 Participants	0 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: From Day 0 to Day 6

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=47 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Irritability, Across doses	2 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Drowsiness, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Irritability, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Temperature/Axillary, Dose 2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Drowsiness, Dose 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Irritability, Dose 3	2 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Loss of appetite, Dose 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Temperature/Axillary, Dose 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Drowsiness, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Loss of appetite, Across doses	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses. Grade 3 Temperature/Axillary, Across doses	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From Day 0 to Day 29

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=47 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Menjugate Group n=50 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=48 Participants 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.
Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)	28 Participants	25 Participants	27 Participants	14 Participants	26 Participants	22 Participants

PRIMARY outcome

Timeframe: From Month 0 to Month 17

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Menjugate Group n=50 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Menjugate Group n=50 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem, PRE, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC, PRE, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA, PRE, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA, PRE, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA, PRE, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 7

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: At Day 37

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=52 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=50 Participants 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.	Control Menjugate Group n=49 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: At Day 67

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: At Month 2

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At Month 3

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: At Month 6

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Six Months post Dose 3 [At Month 13]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At Month 12

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	—	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Twelve Months post Dose 2 [At Month 13]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At Month 14

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	1 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: At Month 8

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Grade 3 Haematological and Biochemical Levels Haem Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels WBC Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels PLA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels ALA Grade 3	0 Participants	1 Participants	0 Participants	—	—	—
Number of Subjects With Grade 3 Haematological and Biochemical Levels CREA Grade 3	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Before vaccination (PRE)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=37 Participants 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.	SB692342 1 Dose Group n=36 Participants 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.	Control Menjugate Group n=42 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=39 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=39 Participants 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.
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 CD4 all doubles, PRE	47 T cells/million cells Interval 23.0 to 87.0	59.5 T cells/million cells Interval 30.5 to 125.0	42.5 T cells/million cells Interval 22.0 to 71.0	88 T cells/million cells Interval 27.0 to 181.0	44.5 T cells/million cells Interval 11.0 to 65.0	52 T cells/million cells Interval 33.0 to 149.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 24.5	1 T cells/million cells Interval 1.0 to 12.0	14 T cells/million cells Interval 1.0 to 53.0	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 30.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 17.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 14.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), PRE	14 T cells/million cells Interval 1.0 to 51.0	1 T cells/million cells Interval 1.0 to 28.0	11.5 T cells/million cells Interval 1.0 to 41.0	3 T cells/million cells Interval 1.0 to 62.0	1 T cells/million cells Interval 1.0 to 16.0	1 T cells/million cells Interval 1.0 to 52.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 24.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 27.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 27.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 6.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 16.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 11.5	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 20.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 15.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 38.0	5.5 T cells/million cells Interval 1.0 to 29.5	1 T cells/million cells Interval 1.0 to 40.0	28 T cells/million cells Interval 1.0 to 63.0	1 T cells/million cells Interval 1.0 to 40.0	20 T cells/million cells Interval 1.0 to 62.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.5	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), PRE	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 27.5	1 T cells/million cells Interval 1.0 to 19.0	1 T cells/million cells Interval 1.0 to 11.0	1.5 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 21.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), PRE	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 21.5	1 T cells/million cells Interval 1.0 to 13.0	12 T cells/million cells Interval 1.0 to 47.0	1 T cells/million cells Interval 1.0 to 22.0	15 T cells/million cells Interval 1.0 to 49.0

SECONDARY outcome

Timeframe: Seven Days post each dose (D7)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=37 Participants 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.	SB692342 1 Dose Group n=42 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.	Control Menjugate Group n=37 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=44 Participants 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.
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 CD4 all doubles, D7	499 T cells/million cells Interval 250.0 to 1267.0	593.5 T cells/million cells Interval 269.0 to 1094.0	128 T cells/million cells Interval 83.0 to 379.0	174 T cells/million cells Interval 67.0 to 321.0	55 T cells/million cells Interval 33.0 to 81.0	52.5 T cells/million cells Interval 33.0 to 85.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	24 T cells/million cells Interval 1.0 to 83.0	42.5 T cells/million cells Interval 14.0 to 66.0	1 T cells/million cells Interval 1.0 to 39.0	16 T cells/million cells Interval 1.0 to 43.0	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 19.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), D7	47 T cells/million cells Interval 15.0 to 143.0	61.5 T cells/million cells Interval 18.0 to 157.0	12 T cells/million cells Interval 1.0 to 25.0	12 T cells/million cells Interval 1.0 to 29.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), D7	25 T cells/million cells Interval 1.0 to 103.0	19.5 T cells/million cells Interval 1.0 to 71.0	1 T cells/million cells Interval 1.0 to 26.0	13 T cells/million cells Interval 1.0 to 38.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), D7	65 T cells/million cells Interval 12.0 to 286.0	82.5 T cells/million cells Interval 29.0 to 320.0	24 T cells/million cells Interval 1.0 to 52.0	14 T cells/million cells Interval 1.0 to 44.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), D7	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 22.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), D7	1 T cells/million cells Interval 1.0 to 32.0	11 T cells/million cells Interval 1.0 to 38.0	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), D7	19 T cells/million cells Interval 9.0 to 61.0	36.5 T cells/million cells Interval 1.0 to 105.0	1 T cells/million cells Interval 1.0 to 19.0	13 T cells/million cells Interval 1.0 to 49.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), D7	52 T cells/million cells Interval 1.0 to 144.0	112 T cells/million cells Interval 25.0 to 297.0	24 T cells/million cells Interval 1.0 to 102.0	21 T cells/million cells Interval 1.0 to 58.0	9 T cells/million cells Interval 1.0 to 63.0	1 T cells/million cells Interval 1.0 to 37.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	12 T cells/million cells Interval 1.0 to 32.0	14.5 T cells/million cells Interval 1.0 to 45.0	1 T cells/million cells Interval 1.0 to 24.0	1 T cells/million cells Interval 1.0 to 21.0	1 T cells/million cells Interval 1.0 to 12.0	11.5 T cells/million cells Interval 1.0 to 15.5
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), D7	64 T cells/million cells Interval 12.0 to 107.0	35.5 T cells/million cells Interval 1.0 to 88.0	3 T cells/million cells Interval 1.0 to 24.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 7.5
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), D7	173 T cells/million cells Interval 38.0 to 232.0	102 T cells/million cells Interval 31.0 to 237.0	22 T cells/million cells Interval 1.0 to 86.0	22 T cells/million cells Interval 1.0 to 67.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 14.5
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), D7	576 T cells/million cells Interval 245.0 to 1126.0	493 T cells/million cells Interval 309.0 to 960.0	138 T cells/million cells Interval 42.0 to 208.0	26 T cells/million cells Interval 1.0 to 134.0	1 T cells/million cells Interval 1.0 to 45.0	1 T cells/million cells Interval 1.0 to 42.5
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), D7	1 T cells/million cells Interval 1.0 to 18.0	1 T cells/million cells Interval 1.0 to 36.0	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), D7	25 T cells/million cells Interval 10.0 to 58.0	27.5 T cells/million cells Interval 5.0 to 85.0	1 T cells/million cells Interval 1.0 to 28.0	1 T cells/million cells Interval 1.0 to 20.0	11 T cells/million cells Interval 1.0 to 21.0	1 T cells/million cells Interval 1.0 to 13.5
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), D7	232 T cells/million cells Interval 85.0 to 444.0	160.5 T cells/million cells Interval 61.0 to 314.0	30 T cells/million cells Interval 5.0 to 69.0	40 T cells/million cells Interval 12.0 to 91.0	1 T cells/million cells Interval 1.0 to 17.0	14 T cells/million cells Interval 1.0 to 44.5

SECONDARY outcome

Timeframe: One Month post each dose (M1)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=41 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=44 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=41 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=42 Participants 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.
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M1	51 T cells/million cells Interval 1.0 to 107.0	51 T cells/million cells Interval 1.0 to 162.0	1 T cells/million cells Interval 1.0 to 50.5	16 T cells/million cells Interval 1.0 to 96.0	1 T cells/million cells Interval 1.0 to 42.0	1 T cells/million cells Interval 1.0 to 42.0
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 CD4 all doubles, M1	640 T cells/million cells Interval 403.0 to 1200.0	859 T cells/million cells Interval 348.0 to 1950.0	173.5 T cells/million cells Interval 93.5 to 476.0	235 T cells/million cells Interval 142.0 to 485.0	31 T cells/million cells Interval 22.0 to 66.0	55.5 T cells/million cells Interval 30.0 to 115.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	52 T cells/million cells Interval 1.0 to 157.0	50 T cells/million cells Interval 12.0 to 253.0	17 T cells/million cells Interval 1.0 to 63.0	25 T cells/million cells Interval 1.0 to 88.0	1 T cells/million cells Interval 1.0 to 12.0	12 T cells/million cells Interval 1.0 to 26.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M1	142 T cells/million cells Interval 48.0 to 300.0	195 T cells/million cells Interval 66.0 to 408.0	30 T cells/million cells Interval 11.5 to 82.5	56 T cells/million cells Interval 14.0 to 88.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 17.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M1	14 T cells/million cells Interval 1.0 to 45.0	24 T cells/million cells Interval 1.0 to 132.0	1 T cells/million cells Interval 1.0 to 14.0	12 T cells/million cells Interval 1.0 to 26.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M1	109 T cells/million cells Interval 49.0 to 143.0	138 T cells/million cells Interval 56.0 to 327.0	27 T cells/million cells Interval 1.0 to 59.0	28 T cells/million cells Interval 12.0 to 63.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M1	1 T cells/million cells Interval 1.0 to 19.0	17 T cells/million cells Interval 1.0 to 37.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 11.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M1	15 T cells/million cells Interval 1.0 to 44.0	14 T cells/million cells Interval 1.0 to 63.0	1 T cells/million cells Interval 1.0 to 6.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M1	14 T cells/million cells Interval 1.0 to 41.0	24 T cells/million cells Interval 1.0 to 64.0	1 T cells/million cells Interval 1.0 to 12.0	12 T cells/million cells Interval 1.0 to 24.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 14.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	28 T cells/million cells Interval 1.0 to 109.0	20 T cells/million cells Interval 1.0 to 60.0	1 T cells/million cells Interval 1.0 to 45.0	12 T cells/million cells Interval 1.0 to 24.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 15.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M1	95 T cells/million cells Interval 32.0 to 251.0	127 T cells/million cells Interval 63.0 to 257.0	28 T cells/million cells Interval 1.0 to 59.5	15 T cells/million cells Interval 1.0 to 78.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M1	57 T cells/million cells Interval 26.0 to 204.0	63 T cells/million cells Interval 27.0 to 118.0	19 T cells/million cells Interval 1.0 to 76.0	24 T cells/million cells Interval 1.0 to 44.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M1	431 T cells/million cells Interval 239.0 to 838.0	449 T cells/million cells Interval 253.0 to 793.0	115.5 T cells/million cells Interval 42.5 to 277.5	127 T cells/million cells Interval 36.0 to 257.0	3 T cells/million cells Interval 1.0 to 33.0	23 T cells/million cells Interval 1.0 to 66.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M1	1 T cells/million cells Interval 1.0 to 27.0	1 T cells/million cells Interval 1.0 to 29.0	1 T cells/million cells Interval 1.0 to 7.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M1	53 T cells/million cells Interval 5.0 to 106.0	51 T cells/million cells Interval 3.0 to 108.0	9.5 T cells/million cells Interval 1.0 to 38.0	19 T cells/million cells Interval 1.0 to 58.0	1 T cells/million cells Interval 1.0 to 15.0	11 T cells/million cells Interval 1.0 to 35.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M1	54 T cells/million cells Interval 18.0 to 107.0	71 T cells/million cells Interval 25.0 to 141.0	19.5 T cells/million cells Interval 1.0 to 49.0	11 T cells/million cells Interval 1.0 to 48.0	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: Six Months post each dose (M6)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=36 Participants 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.	SB692342 1 Dose Group n=40 Participants 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.	Control Menjugate Group n=42 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=44 Participants 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.
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 CD4 all doubles, M6	633 T cells/million cells Interval 324.0 to 1062.0	512 T cells/million cells Interval 318.5 to 992.5	107.5 T cells/million cells Interval 47.0 to 184.0	107 T cells/million cells Interval 72.0 to 191.0	39 T cells/million cells Interval 23.0 to 71.0	41 T cells/million cells Interval 23.0 to 73.5
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	63 T cells/million cells Interval 18.5 to 129.0	65 T cells/million cells Interval 13.0 to 125.0	12 T cells/million cells Interval 1.0 to 28.0	16 T cells/million cells Interval 1.0 to 48.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 13.5
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M6	223 T cells/million cells Interval 78.0 to 403.0	202.5 T cells/million cells Interval 101.5 to 434.0	28 T cells/million cells Interval 1.0 to 50.0	17 T cells/million cells Interval 1.0 to 64.0	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 12.5
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M6	18.5 T cells/million cells Interval 1.0 to 25.5	15.5 T cells/million cells Interval 1.0 to 29.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M6	68.5 T cells/million cells Interval 40.5 to 163.0	65 T cells/million cells Interval 34.5 to 184.5	1 T cells/million cells Interval 1.0 to 22.0	13 T cells/million cells Interval 1.0 to 41.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M6	12 T cells/million cells Interval 1.0 to 20.5	1 T cells/million cells Interval 1.0 to 26.0	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M6	1 T cells/million cells Interval 1.0 to 6.5	1 T cells/million cells Interval 1.0 to 28.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 11.0	1 T cells/million cells Interval 1.0 to 13.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M6	16.5 T cells/million cells Interval 1.0 to 71.0	40.5 T cells/million cells Interval 1.0 to 95.5	1 T cells/million cells Interval 1.0 to 28.0	2 T cells/million cells Interval 1.0 to 44.0	1 T cells/million cells Interval 1.0 to 39.0	13.5 T cells/million cells Interval 1.0 to 48.5
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	13.5 T cells/million cells Interval 1.0 to 59.5	13 T cells/million cells Interval 1.0 to 52.5	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 17.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M6	72 T cells/million cells Interval 38.0 to 206.5	86.5 T cells/million cells Interval 27.0 to 156.5	12 T cells/million cells Interval 1.0 to 28.0	5 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M6	31 T cells/million cells Interval 1.0 to 84.5	26 T cells/million cells Interval 7.0 to 55.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 16.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M6	310.5 T cells/million cells Interval 60.0 to 591.5	171.5 T cells/million cells Interval 126.5 to 369.0	35.5 T cells/million cells Interval 1.0 to 68.0	48 T cells/million cells Interval 8.0 to 99.0	10 T cells/million cells Interval 1.0 to 27.0	12.5 T cells/million cells Interval 1.0 to 41.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M6	1 T cells/million cells Interval 1.0 to 18.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M6	19 T cells/million cells Interval 1.0 to 71.5	27 T cells/million cells Interval 1.0 to 61.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 13.5
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M6	19.5 T cells/million cells Interval 1.0 to 58.0	14 T cells/million cells Interval 1.0 to 46.5	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 16.0	1 T cells/million cells Interval 1.0 to 18.0	1 T cells/million cells Interval 1.0 to 14.0

SECONDARY outcome

Timeframe: Twelve Months post each dose (M12)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=38 Participants 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.	SB692342 1 Dose Group n=41 Participants 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.	Control Menjugate Group n=45 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=41 Participants 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.	Control Menjugate Group n=33 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-), M12	10.5 T cells/million cells Interval 1.0 to 57.0	29 T cells/million cells Interval 1.0 to 81.0	1 T cells/million cells Interval 1.0 to 48.0	14 T cells/million cells Interval 1.0 to 67.0	22 T cells/million cells Interval 1.0 to 58.0	13 T cells/million cells Interval 1.0 to 72.0
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 CD4 all doubles, M12	456.5 T cells/million cells Interval 237.0 to 1062.0	403 T cells/million cells Interval 245.0 to 745.0	104 T cells/million cells Interval 59.0 to 201.0	98 T cells/million cells Interval 52.0 to 157.0	38 T cells/million cells Interval 22.0 to 61.0	41 T cells/million cells Interval 22.0 to 79.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	51 T cells/million cells Interval 18.0 to 145.0	65 T cells/million cells Interval 18.0 to 99.0	16 T cells/million cells Interval 1.0 to 42.0	14 T cells/million cells Interval 1.0 to 48.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 14.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-), M12	176 T cells/million cells Interval 73.0 to 424.0	144 T cells/million cells Interval 80.0 to 329.0	28 T cells/million cells Interval 12.0 to 52.0	26 T cells/million cells Interval 13.0 to 47.0	1 T cells/million cells Interval 1.0 to 14.0	1 T cells/million cells Interval 1.0 to 12.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+), M12	7 T cells/million cells Interval 1.0 to 39.0	13 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-), M12	56.5 T cells/million cells Interval 24.0 to 145.0	67 T cells/million cells Interval 24.0 to 149.0	13 T cells/million cells Interval 1.0 to 21.0	1 T cells/million cells Interval 1.0 to 16.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+), M12	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-), M12	12.5 T cells/million cells Interval 1.0 to 37.0	1 T cells/million cells Interval 1.0 to 23.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0
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 CD4.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+), M12	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 17.0	1 T cells/million cells Interval 1.0 to 13.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 13.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	13 T cells/million cells Interval 1.0 to 29.0	1 T cells/million cells Interval 1.0 to 17.0	1 T cells/million cells Interval 1.0 to 16.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-), M12	60 T cells/million cells Interval 15.0 to 138.0	39 T cells/million cells Interval 13.0 to 91.0	12 T cells/million cells Interval 1.0 to 21.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+), M12	21 T cells/million cells Interval 1.0 to 56.0	19 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-), M12	179 T cells/million cells Interval 84.0 to 283.0	155 T cells/million cells Interval 74.0 to 300.0	30 T cells/million cells Interval 1.0 to 66.0	50 T cells/million cells Interval 22.0 to 87.0	1 T cells/million cells Interval 1.0 to 20.0	3 T cells/million cells Interval 1.0 to 25.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+), M12	1 T cells/million cells Interval 1.0 to 15.0	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-), M12	3.5 T cells/million cells Interval 1.0 to 38.0	1 T cells/million cells Interval 1.0 to 35.0	3 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 39.0	1 T cells/million cells Interval 1.0 to 27.0	1 T cells/million cells Interval 1.0 to 19.0
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 CD4.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+), M12	14.5 T cells/million cells Interval 1.0 to 49.0	2 T cells/million cells Interval 1.0 to 54.0	1 T cells/million cells Interval 1.0 to 25.0	1 T cells/million cells Interval 1.0 to 25.0	1 T cells/million cells Interval 1.0 to 27.0	1 T cells/million cells Interval 1.0 to 41.0

SECONDARY outcome

Timeframe: Before vaccination (PRE)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=37 Participants 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.	SB692342 1 Dose Group n=36 Participants 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.	Control Menjugate Group n=42 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=39 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=39 Participants 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.
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 64.0	1 T cells/million cells Interval 1.0 to 14.5	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 28.0	1 T cells/million cells Interval 1.0 to 27.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),PRE	1 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 23.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 2.0	1 T cells/million cells Interval 1.0 to 43.0
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 CD8 all doubles, PRE	11 T cells/million cells Interval 11.0 to 81.0	40.5 T cells/million cells Interval 11.0 to 70.5	11 T cells/million cells Interval 11.0 to 61.0	11 T cells/million cells Interval 11.0 to 93.0	11 T cells/million cells Interval 11.0 to 65.0	11 T cells/million cells Interval 11.0 to 47.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 44.0	1 T cells/million cells Interval 1.0 to 42.0	1 T cells/million cells Interval 1.0 to 53.0	1 T cells/million cells Interval 1.0 to 46.0	1 T cells/million cells Interval 1.0 to 50.0	1 T cells/million cells Interval 1.0 to 55.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),PRE	8 T cells/million cells Interval 1.0 to 116.0	117 T cells/million cells Interval 40.0 to 260.0	57 T cells/million cells Interval 1.0 to 138.0	61 T cells/million cells Interval 1.0 to 166.0	53.5 T cells/million cells Interval 1.0 to 91.0	65 T cells/million cells Interval 1.0 to 302.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),PRE	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Seven Days after each dose (D7)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=37 Participants 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.	SB692342 1 Dose Group n=42 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.	Control Menjugate Group n=37 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=44 Participants 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.
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),D7	6 T cells/million cells Interval 1.0 to 64.0	7.5 T cells/million cells Interval 1.0 to 72.0	1 T cells/million cells Interval 1.0 to 67.0	1 T cells/million cells Interval 1.0 to 10.0	1 T cells/million cells Interval 1.0 to 85.0	1 T cells/million cells Interval 1.0 to 48.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),D7	37 T cells/million cells Interval 1.0 to 89.0	1 T cells/million cells Interval 1.0 to 50.0	1 T cells/million cells Interval 1.0 to 70.0	1 T cells/million cells Interval 1.0 to 31.0	1 T cells/million cells Interval 1.0 to 30.0	1 T cells/million cells Interval 1.0 to 2.5
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 CD8 all doubles, D7	61 T cells/million cells Interval 11.0 to 147.0	55 T cells/million cells Interval 11.0 to 161.0	43 T cells/million cells Interval 11.0 to 101.0	46 T cells/million cells Interval 11.0 to 82.0	11 T cells/million cells Interval 11.0 to 11.0	11 T cells/million cells Interval 11.0 to 28.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 31.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),D7	34 T cells/million cells Interval 1.0 to 104.0	37 T cells/million cells Interval 1.0 to 119.0	6 T cells/million cells Interval 1.0 to 116.0	1 T cells/million cells Interval 1.0 to 100.0	3 T cells/million cells Interval 1.0 to 54.0	1 T cells/million cells Interval 1.0 to 25.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),D7	61 T cells/million cells Interval 1.0 to 185.0	161.5 T cells/million cells Interval 1.0 to 574.0	1 T cells/million cells Interval 1.0 to 107.0	34 T cells/million cells Interval 1.0 to 303.0	1 T cells/million cells Interval 1.0 to 61.0	123 T cells/million cells Interval 1.0 to 289.5
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),D7	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: One Month after each dose (M1)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=41 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=44 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=41 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=42 Participants 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.
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 32.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 12.0	1 T cells/million cells Interval 1.0 to 28.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8 all doubles, M1	69 T cells/million cells Interval 11.0 to 145.0	82 T cells/million cells Interval 11.0 to 163.0	29.5 T cells/million cells Interval 11.0 to 80.0	81 T cells/million cells Interval 26.0 to 139.0	11 T cells/million cells Interval 11.0 to 28.0	11 T cells/million cells Interval 11.0 to 53.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 32.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 56.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 55.0	1 T cells/million cells Interval 1.0 to 46.0	1 T cells/million cells Interval 1.0 to 52.0	11 T cells/million cells Interval 1.0 to 99.0	2.5 T cells/million cells Interval 1.0 to 85.0	4 T cells/million cells Interval 1.0 to 109.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M1	1 T cells/million cells Interval 1.0 to 139.0	142 T cells/million cells Interval 1.0 to 308.0	2.5 T cells/million cells Interval 1.0 to 116.0	109 T cells/million cells Interval 2.0 to 218.0	1 T cells/million cells Interval 1.0 to 48.0	86 T cells/million cells Interval 1.0 to 330.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M1	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M1	18 T cells/million cells Interval 1.0 to 87.0	12 T cells/million cells Interval 1.0 to 111.0	1 T cells/million cells Interval 1.0 to 50.0	1 T cells/million cells Interval 1.0 to 90.0	1 T cells/million cells Interval 1.0 to 51.0	1 T cells/million cells Interval 1.0 to 35.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M1	1 T cells/million cells Interval 1.0 to 65.0	1 T cells/million cells Interval 1.0 to 65.0	1 T cells/million cells Interval 1.0 to 5.5	1 T cells/million cells Interval 1.0 to 64.0	1 T cells/million cells Interval 1.0 to 5.0	1 T cells/million cells Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Six Months after each dose (M6)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=36 Participants 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.	SB692342 1 Dose Group n=40 Participants 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.	Control Menjugate Group n=42 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.	Control Menjugate Group n=34 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=44 Participants 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.
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 CD8 all doubles, M6	11 T cells/million cells Interval 11.0 to 53.0	11 T cells/million cells Interval 11.0 to 20.0	11 T cells/million cells Interval 11.0 to 32.0	11 T cells/million cells Interval 11.0 to 11.0	11 T cells/million cells Interval 11.0 to 29.0	11 T cells/million cells Interval 11.0 to 11.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 25.5	2 T cells/million cells Interval 1.0 to 65.0	1 T cells/million cells Interval 1.0 to 44.0	1 T cells/million cells Interval 1.0 to 63.0	1 T cells/million cells Interval 1.0 to 52.0	2 T cells/million cells Interval 1.0 to 59.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 29.5	27.5 T cells/million cells Interval 1.0 to 60.0	38 T cells/million cells Interval 1.0 to 91.0	1 T cells/million cells Interval 1.0 to 56.0	28 T cells/million cells Interval 1.0 to 67.0	1 T cells/million cells Interval 1.0 to 43.5
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M6	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M6	1 T cells/million cells Interval 1.0 to 54.5	1 T cells/million cells Interval 1.0 to 55.5	1 T cells/million cells Interval 1.0 to 3.0	1 T cells/million cells Interval 1.0 to 60.0	1 T cells/million cells Interval 1.0 to 36.0	1 T cells/million cells Interval 1.0 to 49.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M6	1 T cells/million cells Interval 1.0 to 33.0	1 T cells/million cells Interval 1.0 to 36.5	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 40.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Twelve Months after each dose (M12)

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=38 Participants 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.	SB692342 1 Dose Group n=41 Participants 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.	Control Menjugate Group n=45 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=41 Participants 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.	Control Menjugate Group n=33 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=43 Participants 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.
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ(+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 5.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8 all doubles, M12	11 T cells/million cells Interval 11.0 to 52.0	11 T cells/million cells Interval 11.0 to 35.0	11 T cells/million cells Interval 11.0 to 38.0	11 T cells/million cells Interval 11.0 to 41.0	11 T cells/million cells Interval 11.0 to 41.0	11 T cells/million cells Interval 11.0 to 42.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (+), M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α(+)+INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+INF-γ (+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(+)+TNF-α (-)+I INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α(+)+INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(+)+IL-2(-)+TNF-α (-)+INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 29.0	1 T cells/million cells Interval 1.0 to 64.0	1 T cells/million cells Interval 1.0 to 68.0	1 T cells/million cells Interval 1.0 to 35.0	1 T cells/million cells Interval 1.0 to 32.0	1 T cells/million cells Interval 1.0 to 40.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α(+)+INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (+),M12	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0	1 T cells/million cells Interval 1.0 to 1.0
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 CD8.CD40-L(-)+IL-2(+)+TNF-α (-)+INF-γ (-),M12	14.5 T cells/million cells Interval 1.0 to 92.0	16 T cells/million cells Interval 1.0 to 77.0	1 T cells/million cells Interval 1.0 to 59.0	1 T cells/million cells Interval 1.0 to 35.0	1 T cells/million cells Interval 1.0 to 57.0	15 T cells/million cells Interval 1.0 to 66.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (+)+INF-γ (-),M12	1 T cells/million cells Interval 1.0 to 34.0	1 T cells/million cells Interval 1.0 to 50.0	1 T cells/million cells Interval 1.0 to 58.0	1 T cells/million cells Interval 1.0 to 65.0	1 T cells/million cells Interval 1.0 to 117.0	1 T cells/million cells Interval 1.0 to 22.0
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 CD8.CD40-L(-)+IL-2(-)+TNF-α (-)+INF-γ(+),M12	1.5 T cells/million cells Interval 1.0 to 67.0	1 T cells/million cells Interval 1.0 to 48.0	1 T cells/million cells Interval 1.0 to 25.0	1 T cells/million cells Interval 1.0 to 128.0	11 T cells/million cells Interval 1.0 to 57.0	1 T cells/million cells Interval 1.0 to 33.0

SECONDARY outcome

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

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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).

Outcome measures

Measure	SB692342 2 Dose Group n=43 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=46 Participants 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.	Control Menjugate Group n=39 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=46 Participants 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.
Number of Seropositive Subjects Against M72 Antigen Anti-M72, M1	42 Participants	43 Participants	39 Participants	39 Participants	1 Participants	0 Participants
Number of Seropositive Subjects Against M72 Antigen Anti-M72, M6	40 Participants	41 Participants	32 Participants	35 Participants	0 Participants	1 Participants
Number of Seropositive Subjects Against M72 Antigen Anti-M72, PRE	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Seropositive Subjects Against M72 Antigen Anti-M72, M12	41 Participants	42 Participants	35 Participants	31 Participants	1 Participants	2 Participants

SECONDARY outcome

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

Population: The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=43 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=46 Participants 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.	Control Menjugate Group n=39 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=46 Participants 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.
Concentration of Antibodies Against M72 Antigen Anti-M72, PRE	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.5 EL.U/mL Interval 1.3 to 1.7	1.4 EL.U/mL Interval 1.4 to 1.4
Concentration of Antibodies Against M72 Antigen Anti-M72, M1	1275.2 EL.U/mL Interval 981.3 to 1657.2	1264 EL.U/mL Interval 928.0 to 1721.5	8 EL.U/mL Interval 6.0 to 10.7	7.4 EL.U/mL Interval 5.3 to 10.2	1.5 EL.U/mL Interval 1.3 to 1.7	1.4 EL.U/mL Interval 1.4 to 1.4
Concentration of Antibodies Against M72 Antigen Anti-M72, M6	98.9 EL.U/mL Interval 75.2 to 130.1	102.6 EL.U/mL Interval 78.7 to 133.9	4.6 EL.U/mL Interval 3.4 to 6.2	4.9 EL.U/mL Interval 3.8 to 6.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.5
Concentration of Antibodies Against M72 Antigen Anti-M72, M12	68.3 EL.U/mL Interval 50.7 to 92.0	76 EL.U/mL Interval 56.6 to 102.0	5.3 EL.U/mL Interval 3.9 to 7.0	4.3 EL.U/mL Interval 3.2 to 5.8	1.4 EL.U/mL Interval 1.4 to 1.5	1.5 EL.U/mL Interval 1.4 to 1.7

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=43 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) Anti-D, PRE	6 Participants	10 Participants	6 Participants	—	—	—
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) Anti-D, PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) Anti-T, PRE	32 Participants	35 Participants	35 Participants	—	—	—
Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T) Anti-T, PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=43 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-D, Anti-T Antibody Concentrations Anti-D, PRE	0.1 IU/mL Interval 0.1 to 0.1	0.1 IU/mL Interval 0.1 to 0.1	0.1 IU/mL Interval 0.1 to 0.1	—	—	—
Anti-D, Anti-T Antibody Concentrations Anti-D, PIII(M3)	2.1 IU/mL Interval 1.6 to 2.7	2.4 IU/mL Interval 1.8 to 3.1	2.5 IU/mL Interval 2.0 to 3.1	—	—	—
Anti-D, Anti-T Antibody Concentrations Anti-T, PRE	0.6 IU/mL Interval 0.4 to 1.0	1 IU/mL Interval 0.6 to 1.5	1 IU/mL Interval 0.6 to 1.6	—	—	—
Anti-D, Anti-T Antibody Concentrations Anti-T, PIII(M3)	5.5 IU/mL Interval 4.3 to 7.1	4.8 IU/mL Interval 3.6 to 6.4	6.3 IU/mL Interval 4.8 to 8.3	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=47 Participants 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.	SB692342 1 Dose Group n=46 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) Anti-PRP, PRE	8 Participants	14 Participants	12 Participants	—	—	—
Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP) Anti-PRP, PIII(M3)	44 Participants	44 Participants	43 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=47 Participants 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.	SB692342 1 Dose Group n=46 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-PRP Antibody Concentrations Anti-PRP, PRE	0.1 µg/mL Interval 0.1 to 0.1	0.1 µg/mL Interval 0.1 to 0.2	0.1 µg/mL Interval 0.1 to 0.2	—	—	—
Anti-PRP Antibody Concentrations Anti-PRP, PIII(M3)	28.2 µg/mL Interval 20.3 to 39.1	30.3 µg/mL Interval 21.8 to 42.1	31.2 µg/mL Interval 21.8 to 44.7	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) Anti-BPT, PRE	1 Participants	1 Participants	1 Participants	—	—	—
Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT) Anti-BPT, PIII(M3)	44 Participants	43 Participants	43 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=43 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-BPT Antibody Concentrations Anti-BPT, PRE	7.7 EL.U/mL Interval 7.3 to 8.0	7.6 EL.U/mL Interval 7.4 to 7.9	7.6 EL.U/mL Interval 7.4 to 7.9	—	—	—
Anti-BPT Antibody Concentrations Anti-BPT, PIII(M3)	139.4 EL.U/mL Interval 117.7 to 164.9	132.1 EL.U/mL Interval 116.6 to 149.5	131.5 EL.U/mL Interval 113.5 to 152.5	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) Anti-HB, PRE	9 Participants	14 Participants	13 Participants	—	—	—
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) Anti-HB, PIII(M3)	42 Participants	43 Participants	42 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL Anti-HB, PRE	2 Participants	2 Participants	2 Participants	—	—	—
Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL Anti-HB, PIII(M3)	42 Participants	42 Participants	42 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-HB Antibody Concentrations Anti-HB, PRE	8.3 mIU/mL Interval 6.0 to 11.4	10 mIU/mL Interval 7.1 to 14.0	9 mIU/mL Interval 6.7 to 12.2	—	—	—
Anti-HB Antibody Concentrations Anti-HB, PIII(M3)	1725.5 mIU/mL Interval 1045.0 to 2849.0	1471.8 mIU/mL Interval 947.5 to 2286.0	2153 mIU/mL Interval 1468.2 to 3157.4	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=46 Participants 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.	SB692342 1 Dose Group n=45 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio1, PRE	36 Participants	38 Participants	39 Participants	—	—	—
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio1, PIII(M3)	41 Participants	43 Participants	42 Participants	—	—	—
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio2, PRE	33 Participants	32 Participants	38 Participants	—	—	—
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio2, PIII(M3)	43 Participants	42 Participants	42 Participants	—	—	—
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio3, PRE	21 Participants	18 Participants	14 Participants	—	—	—
Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3) Anti-Polio3, PIII(M3)	42 Participants	38 Participants	39 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=46 Participants 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.	SB692342 1 Dose Group n=45 Participants 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.	Control Menjugate Group n=48 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio3, PIII(M3)	154.8 Titers Interval 100.8 to 237.8	103.5 Titers Interval 59.7 to 179.6	123 Titers Interval 73.6 to 205.8	—	—	—
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio1, PRE	56.3 Titers Interval 30.7 to 103.2	48.8 Titers Interval 27.3 to 87.5	103.8 Titers Interval 58.1 to 185.3	—	—	—
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio1, PIII(M3)	299.9 Titers Interval 167.6 to 536.7	397.8 Titers Interval 240.2 to 658.8	573.1 Titers Interval 368.7 to 890.6	—	—	—
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio2, PRE	51.8 Titers Interval 28.8 to 93.2	53.2 Titers Interval 28.0 to 101.0	61.2 Titers Interval 34.8 to 107.8	—	—	—
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio2, PIII(M3)	458.7 Titers Interval 307.7 to 683.7	524.3 Titers Interval 331.1 to 830.3	499.9 Titers Interval 317.7 to 786.5	—	—	—
Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers Anti-Polio3, PRE	15.2 Titers Interval 9.0 to 25.6	15.4 Titers Interval 8.6 to 27.6	10.9 Titers Interval 6.7 to 17.9	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-6B, PRE	29 Participants	27 Participants	26 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-6B, PIII(M3)	44 Participants	41 Participants	40 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-19F, PRE	35 Participants	37 Participants	39 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-19F, PIII(M3)	44 Participants	44 Participants	43 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-4, PRE	18 Participants	21 Participants	12 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-4, PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-9V, PRE	28 Participants	33 Participants	25 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-9V,PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-14, PRE	39 Participants	38 Participants	38 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-14, PIII(M3)	44 Participants	44 Participants	43 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-18C, PRE	30 Participants	35 Participants	26 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-18C, PIII(M3)	43 Participants	44 Participants	43 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-23F, PRE	25 Participants	30 Participants	26 Participants	—	—	—
Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F) Anti-23F, PIII(M3)	43 Participants	43 Participants	42 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-19F, PIII(M3)	43 Participants	44 Participants	43 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-14, PRE	34 Participants	33 Participants	33 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-14, PIII(M3)	44 Participants	43 Participants	43 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-18C, PRE	10 Participants	17 Participants	9 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-18C, PIII(M3)	43 Participants	43 Participants	42 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-19F, PRE	30 Participants	30 Participants	26 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-4, PRE	5 Participants	10 Participants	2 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-4, PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-6B, PRE	8 Participants	5 Participants	6 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-6B, PIII(M3)	38 Participants	40 Participants	35 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-9V, PRE	18 Participants	20 Participants	10 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-9V, PIII(M3)	43 Participants	43 Participants	43 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-23F, PRE	9 Participants	11 Participants	14 Participants	—	—	—
Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter Anti-23F, PIII(M3)	42 Participants	41 Participants	42 Participants	—	—	—

SECONDARY outcome

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

Population: The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	SB692342 2 Dose Group n=44 Participants 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.	SB692342 1 Dose Group n=44 Participants 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.	Control Menjugate Group n=43 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-6B, PIII(M3)	2.3 µg/mL Interval 1.4 to 3.8	1.5 µg/mL Interval 0.9 to 2.4	1.5 µg/mL Interval 0.8 to 2.7	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-9V, PRE	0.1 µg/mL Interval 0.1 to 0.1	0.2 µg/mL Interval 0.1 to 0.3	0.1 µg/mL Interval 0.1 to 0.1	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-4, PRE	0.1 µg/mL Interval 0.0 to 0.1	0.1 µg/mL Interval 0.1 to 0.1	0 µg/mL Interval 0.0 to 0.0	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-4, PIII(M3)	7.7 µg/mL Interval 6.2 to 9.7	6.4 µg/mL Interval 5.3 to 7.8	8.1 µg/mL Interval 6.5 to 10.0	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-6B, PRE	0.1 µg/mL Interval 0.1 to 0.1	0.1 µg/mL Interval 0.1 to 0.1	0.1 µg/mL Interval 0.1 to 0.1	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-9V, PIII(M3)	5.8 µg/mL Interval 4.4 to 7.7	4.1 µg/mL Interval 3.0 to 5.6	6 µg/mL Interval 4.5 to 8.1	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-14, PRE	0.8 µg/mL Interval 0.6 to 1.2	1.1 µg/mL Interval 0.7 to 1.6	0.7 µg/mL Interval 0.4 to 1.0	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-14, PIII(M3)	3.6 µg/mL Interval 2.5 to 5.3	3.3 µg/mL Interval 2.3 to 4.7	4.2 µg/mL Interval 2.8 to 6.2	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-18C, PRE	0.1 µg/mL Interval 0.1 to 0.1	0.2 µg/mL Interval 0.1 to 0.2	0.1 µg/mL Interval 0.1 to 0.1	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-18C, PIII(M3)	7.2 µg/mL Interval 5.7 to 9.0	5.1 µg/mL Interval 3.8 to 7.0	6.1 µg/mL Interval 4.2 to 8.8	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-19F, PRE	0.4 µg/mL Interval 0.3 to 0.6	0.5 µg/mL Interval 0.3 to 0.7	0.3 µg/mL Interval 0.2 to 0.5	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-19F, PIII(M3)	5.8 µg/mL Interval 4.1 to 8.2	5.4 µg/mL Interval 4.2 to 6.9	5.9 µg/mL Interval 4.5 to 7.5	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-23F, PRE	0.1 µg/mL Interval 0.1 to 0.1	0.1 µg/mL Interval 0.1 to 0.1	0.1 µg/mL Interval 0.1 to 0.1	—	—	—
Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations Anti-23F, PIII(M3)	3.2 µg/mL Interval 2.1 to 4.8	3 µg/mL Interval 2.0 to 4.6	3.8 µg/mL Interval 2.5 to 5.7	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to 12 months post last vaccination

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Menjugate Group n=50 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	1 Participants	3 Participants	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Before vaccination (PRE)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 Participants 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.	Control Menjugate Group n=50 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 Participants 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.
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers WBC, PRE, G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers PLA, PRE, G1	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers PLA, PRE, G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers PLA, PRE, Missing	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers ALA, PRE, Normal	42 Participants	47 Participants	39 Participants	51 Participants	40 Participants	48 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers ALA, PRE, Missing	8 Participants	1 Participants	11 Participants	1 Participants	9 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers CREA, PRE, G1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers WBC, PRE, G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers WBC, PRE, Missing	5 Participants	1 Participants	1 Participants	0 Participants	7 Participants	2 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers PLA, PRE, Normal	48 Participants	49 Participants	49 Participants	52 Participants	48 Participants	49 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers PLA, PRE, G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers Haem, PRE, Normal	49 Participants	48 Participants	50 Participants	51 Participants	48 Participants	49 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers Haem, PRE, G1	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers Haem, PRE, G2	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers Haem, PRE, G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers Haem, PRE, Missing	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers WBC, PRE, Normal	45 Participants	48 Participants	49 Participants	52 Participants	43 Participants	47 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers WBC, PRE, G1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers ALA, PRE, G1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers ALA, PRE, G2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers ALA, PRE, G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers CREA, PRE, Normal	42 Participants	48 Participants	39 Participants	51 Participants	41 Participants	49 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers CREA, PRE, G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers CREA, PRE, G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers CREA, PRE, Missing	8 Participants	1 Participants	11 Participants	1 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Seven days post Dose 1 [PI(D7)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(D7), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(D7), Normal	46 Participants	47 Participants	45 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(D7), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(D7), Normal	49 Participants	49 Participants	47 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(D7), Normal	49 Participants	48 Participants	48 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(D7), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(D7), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(D7), Missing	1 Participants	2 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(D7), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(D7), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(D7), Missing	4 Participants	3 Participants	5 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(D7), G1	0 Participants	1 Participants	1 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(D7), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(D7), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(D7), Missing	0 Participants	0 Participants	1 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(D7), Normal	48 Participants	48 Participants	48 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(D7), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(D7), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(D7), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(D7), Missing	2 Participants	2 Participants	2 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(D7), Normal	48 Participants	48 Participants	49 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(D7), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(D7), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(D7), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(D7), Missing	2 Participants	2 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Seven days post Dose 2 [PII(D37)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=49 Participants 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.	Control Menjugate Group n=52 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=50 Participants 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.	Control Menjugate Group n=49 Participants 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(D37), Missing	8 Participants	5 Participants	52 Participants	6 Participants	5 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(D37), Normal	48 Participants	46 Participants	0 Participants	48 Participants	47 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(D37), Missing	2 Participants	3 Participants	52 Participants	2 Participants	2 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(D37), Normal	47 Participants	45 Participants	0 Participants	47 Participants	47 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(D37), G1	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(D37), G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(D37), G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(D37), Missing	2 Participants	4 Participants	52 Participants	2 Participants	2 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(D37), Normal	42 Participants	44 Participants	0 Participants	44 Participants	44 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(D37), G1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(D37), G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(D37), G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(D37), Normal	47 Participants	45 Participants	0 Participants	48 Participants	47 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(D37), G1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(D37), G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(D37), G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(D37), Missing	2 Participants	4 Participants	52 Participants	2 Participants	2 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(D37), Normal	48 Participants	46 Participants	0 Participants	48 Participants	47 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(D37), G1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(D37), G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(D37), G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(D37), Missing	2 Participants	3 Participants	52 Participants	2 Participants	2 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(D37), G1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(D37), G2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(D37), G4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Seven days post Dose 3 [PIII(D67)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(D67), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(D67), Normal	46 Participants	51 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(D67), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(D67), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(D67), Missing	3 Participants	1 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(D67), Normal	44 Participants	49 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(D67), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(D67), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(D67), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(D67), Missing	5 Participants	3 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(D67), Normal	46 Participants	51 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(D67), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(D67), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(D67), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(D67), Missing	3 Participants	1 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(D67), Normal	46 Participants	51 Participants	45 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(D67), G1	0 Participants	1 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(D67), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(D67), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(D67), Missing	3 Participants	0 Participants	4 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(D67), Normal	46 Participants	52 Participants	45 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(D67), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(D67), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(D67), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(D67), Missing	3 Participants	0 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: One Month post Dose 1 [PI(M1)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group n=50 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M1), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M1), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M1), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M1), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M1), Normal	0 Participants	45 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M1), G1	0 Participants	2 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M1), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M1), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M1), Missing	50 Participants	3 Participants	50 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M1), Normal	0 Participants	46 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M1), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M1), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M1), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M1), Missing	50 Participants	4 Participants	50 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M1), Normal	0 Participants	47 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M1), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M1), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M1), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M1), Missing	50 Participants	3 Participants	50 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M1), Normal	0 Participants	42 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M1), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M1), Missing	50 Participants	8 Participants	50 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M1), Normal	0 Participants	42 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M1), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M1), Missing	50 Participants	8 Participants	50 Participants	—	—	—

SECONDARY outcome

Timeframe: One Month post Dose 2 [PII(M2)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M2), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M2), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M2), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M2), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M2), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M2), Missing	8 Participants	14 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M2), Normal	42 Participants	36 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M2), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M2), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M2), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M2), Missing	8 Participants	14 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M2), Normal	47 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M2), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M2), Missing	3 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M2), Normal	45 Participants	41 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M2), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M2), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M2), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M2), Missing	5 Participants	9 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M2), Normal	47 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M2), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M2), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M2), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M2), Missing	3 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M2), Normal	42 Participants	36 Participants	—	—	—	—

SECONDARY outcome

Timeframe: One Month post Dose 3 [PIII(M3)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M3), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M3), Normal	46 Participants	49 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M3), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M3), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M3), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M3), Missing	3 Participants	3 Participants	5 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M3), Normal	45 Participants	48 Participants	43 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M3), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M3), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M3), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M3), Missing	4 Participants	4 Participants	6 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M3), Normal	46 Participants	48 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M3), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M3), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M3), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M3), Missing	3 Participants	3 Participants	5 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M3), Normal	46 Participants	50 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M3), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M3), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M3), Missing	3 Participants	2 Participants	5 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M3), Normal	46 Participants	50 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M3), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M3), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M3), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M3), Missing	3 Participants	2 Participants	5 Participants	—	—	—

SECONDARY outcome

Timeframe: Six Months post Dose 1 [PI(M6)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M6), Normal	46 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M6), G1	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M6), Normal	41 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M6), G1	4 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M6), G2	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M6), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M6), Missing	4 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M6), Normal	45 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M6), G1	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M6), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M6), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M6), Missing	5 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M6), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M6), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M6), Missing	4 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M6), Normal	45 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M6), G1	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M6), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M6), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M6), Missing	4 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M6), Normal	46 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M6), G1	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M6), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M6), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M6), Missing	4 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Six Months post Dose 2 [PII(M7)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M7), Normal	42 Participants	41 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M7), G1	3 Participants	3 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M7), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M7), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M7), Missing	5 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M7), Normal	42 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M7), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M7), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M7), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M7), Missing	8 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M7), Normal	45 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M7), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M7), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M7), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M7), Missing	5 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M7), Normal	43 Participants	43 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M7), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M7), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M7), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M7), Missing	7 Participants	7 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M7), Normal	43 Participants	43 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M7), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M7), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M7), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M7), Missing	7 Participants	7 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Six Months post Dose 3 [PIII(M8)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M8), Normal	43 Participants	47 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M8), G1	1 Participants	4 Participants	2 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M8), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M8), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M8), Missing	5 Participants	1 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M8), Normal	41 Participants	47 Participants	41 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M8), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M8), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M8), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M8), Missing	8 Participants	5 Participants	8 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M8), Normal	44 Participants	50 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M8), G1	0 Participants	1 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M8), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M8), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M8), Missing	5 Participants	1 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M8), Normal	43 Participants	50 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M8), G1	1 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M8), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M8), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M8), Missing	5 Participants	1 Participants	3 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M8), Normal	43 Participants	51 Participants	46 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M8), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M8), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M8), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M8), Missing	6 Participants	1 Participants	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Six Months post Dose 3 [PIII(M13)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M13), Normal	0 Participants	43 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M13), G1	0 Participants	1 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M13), Missing	50 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M13), Normal	0 Participants	42 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M13), Missing	50 Participants	8 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M13), Normal	0 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M13), Missing	50 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M13), Normal	0 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M13), Missing	50 Participants	6 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M13), Normal	0 Participants	44 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M13), Missing	50 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Twelve Months post Dose 1 [PI(M12)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M12), Missing	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M12), Normal	48 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M12), G1	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M12), G1	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M12), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M12), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M12), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M12), Missing	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M12), Normal	49 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M12), G1	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M12), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M12), Missing	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M12), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M12), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M12), G2	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M12), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PI(M12), Missing	2 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M12), Normal	48 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PI(M12), Missing	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M12), Normal	46 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M12), G1	2 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PI(M12), G2	1 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PI(M12), G4	0 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M12), Normal	47 Participants	—	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PI(M12), G1	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Twelve Months post Dose 2 [PII(M13)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=50 Participants 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.	SB692342 1 Dose Group n=50 Participants 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.	Control Menjugate Group 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M13), Normal	41 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M13), Missing	4 Participants	50 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M13), Normal	43 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M13), Missing	4 Participants	50 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M13), Normal	46 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M13), Missing	4 Participants	50 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M13), G1	4 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PII(M13), G2	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PII(M13), Missing	7 Participants	50 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M13), Normal	46 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M13), G1	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M13), Normal	45 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M13), G1	1 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M13), G2	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M13), G4	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PII(M13), Missing	4 Participants	50 Participants	—	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PII(M13), G4	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Twelve Months post Dose 3 [PIII(M14)]

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.

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.

Outcome measures

Measure	SB692342 2 Dose Group n=49 Participants 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.	SB692342 1 Dose Group n=52 Participants 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.	Control Menjugate Group n=49 Participants 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group 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.	Control Menjugate Group 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.	Control Tritanrix + Prevnar + Polio Sabin Group 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.
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M14), G1	6 Participants	5 Participants	8 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M14), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M14), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M14), Normal	38 Participants	46 Participants	37 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M14), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers Haem, PIII(M14), Missing	5 Participants	1 Participants	4 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M14), Normal	42 Participants	48 Participants	42 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M14), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M14), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers WBC, PIII(M14), Missing	7 Participants	4 Participants	7 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M14), Normal	44 Participants	51 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M14), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M14), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M14), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers PLA, PIII(M14), Missing	5 Participants	1 Participants	4 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M14), Normal	43 Participants	51 Participants	43 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M14), G1	1 Participants	0 Participants	1 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M14), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M14), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers ALA, PIII(M14), Missing	5 Participants	1 Participants	5 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M14), Normal	44 Participants	51 Participants	44 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M14), G1	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M14), G2	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M14), G4	0 Participants	0 Participants	0 Participants	—	—	—
Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers CREA, PIII(M14), Missing	5 Participants	1 Participants	5 Participants	—	—	—

Adverse Events

SB692342 2 Dose Group

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

SB692342 1 Dose Group

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Control Menjugate Group

Serious events: 3 serious events

Other events: 31 other events

Deaths: 1 deaths

SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Control Tritanrix + Prevnar + Polio Sabin Group

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	SB692342 2 Dose Group n=50 participants at risk 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.	SB692342 1 Dose Group n=50 participants at risk 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.	Control Menjugate Group n=50 participants at risk 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.	SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group n=49 participants at risk 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 participants at risk 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 participants at risk 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.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Nervous system disorders Febrile convulsion	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	1.9% 1/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Pyrexia	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Skin and subcutaneous tissue disorders Rash	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Sepsis	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Bronchopneumonia	4.0% 2/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Gastroenteritis	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Cerebral malaria	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Malaria	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.

Other adverse events

Measure	SB692342 2 Dose Group n=50 participants at risk 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.	SB692342 1 Dose Group n=50 participants at risk 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.	Control Menjugate Group n=50 participants at risk 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.	SB692392 2 Dose + Tritanrix + Prevnar + Polio Sabin Group n=49 participants at risk 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.	SB692392 1 Dose + Tritanrix + Prevnar + Polio Sabin Group n=52 participants at risk 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.	Control Tritanrix + Prevnar + Polio Sabin Group n=49 participants at risk 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.
Eye disorders Conjunctivitis	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	6.1% 3/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Pyrexia	6.0% 3/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	8.0% 4/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	3.8% 2/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Pain	12.0% 6/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	4.0% 2/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	12.0% 6/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	20.4% 10/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	25.0% 13/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	26.5% 13/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Swelling	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	12.2% 6/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	15.4% 8/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	16.3% 8/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Drowsiness	4.0% 2/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	6.1% 3/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	5.8% 3/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Irritability	6.0% 3/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	4.0% 2/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	16.3% 8/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	9.6% 5/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	8.2% 4/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Loss of appetite	6.0% 3/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	2.0% 1/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	6.1% 3/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	3.8% 2/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	0.00% 0/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
General disorders Temperature (Axillary)	38.0% 19/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	10.0% 5/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	26.0% 13/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	36.7% 18/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	17.3% 9/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	24.5% 12/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Gastrointestinal disorders Diarrhoea	16.0% 8/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	10.0% 5/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	4.0% 2/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	10.2% 5/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	1.9% 1/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	6.1% 3/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.
Infections and infestations Respiratory tract infection	42.0% 21/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	28.0% 14/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	38.0% 19/50 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	30.6% 15/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	17.3% 9/52 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.	28.6% 14/49 • 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. Other Adverse Events were collected from all subjects with at least one administered dose with safety follow-up and who completed their symptom sheet.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER