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Clinical Trial Results:
Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (SHAN6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand

Summary
EudraCT number	2021-006686-37
Trial protocol	Outside EU/EEA
Global end of trial date	20 Nov 2021

Results information
Results version number	v1(current)
This version publication date	11 Aug 2022
First version publication date	11 Aug 2022
Other versions

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

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Trial information

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Sponsor protocol code

SH600009

ISRCTN number

US NCT number

NCT04429295

WHO universal trial number (UTN)

U1111-1233-9694

Sponsor organisation name

Sanofi Pasteur

Sponsor organisation address

14 Espace Henry Vallée, Lyon, France, 69007

Public contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com

Scientific contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

05 May 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 Nov 2021

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the non-inferiority of the SHAN6 vaccine to the licensed SHAN5 given with bivalent oral polio vaccine (bOPV) and inactivated poliomyelitis vaccine (IPV) vaccines in terms of adjusted geometric mean concentration (aGMC) for the pertussis antigens anti-pertussis toxin (PT) and anti-fimbriae (FIM) and seroprotection rates for all other antigens 28 days after the 3-dose primary infant vaccination when co-administered with pneumococcal 13-valent conjugate vaccine (PCV) [Prevnar 13] and oral rotavirus vaccine (ORV-1) [Rotarix]).

Protection of trial subjects

Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions. Safety of trial subjects were monitored during the conduct of the study.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Jun 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Thailand: 460

Worldwide total number of subjects

460

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

460

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 3 active sites in Thailand from 28 June 2020 to 20 November 2021. A total of 460 subjects were enrolled and randomized in the study.

Screening details

Subjects who returned for Visit 05 before end of September 2021 received a booster dose of SHAN6 and subjects who returned for Visit 05 after September 2021 received a booster dose of a licensed vaccine as per local standard of care.

Period 1 title

Primary Phase (Up to Day 148)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Primary Phase: Group A: SHAN6

Arm description

Subjects aged 2 months (at the time of enrollment) received SHAN6 vaccine at the age of Months 2, 4, and 6, co-administered with Prevnar 13 vaccine (i.e., pneumococcal 13-valent conjugate vaccine [PCV]) at the age of Months 2, 4, and 6; and Rotarix (i.e., oral rotavirus vaccine [ORV-1]) vaccine at the age of Months 2, and 4.

Arm type

Experimental

Investigational medicinal product name

Hexavalent DTwP-HepB-Hib-IPV vaccine

Investigational medicinal product code

Other name

SHAN6™

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 milliliters (mL), intramuscular dose.

Investigational medicinal product name

Human Rotavirus, live attenuated (ORV)

Investigational medicinal product code

Other name

Rotarix

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

1.5 mL, oral dose.

Investigational medicinal product name

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (PCV)

Investigational medicinal product code

Other name

Prevnar 13®

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular dose.

Primary Phase: Group B: SHAN 5 + bOPV + IPV

Arm description

Subjects aged 2 months (at the time of enrollment) received SHAN5™ along with bOPV at the age of Months 2, 4, and 6, and IPV at the age of Month 4; co-administered with Prevnar 13 vaccine at the age of Months 2, 4, and 6; and Rotarix vaccine at the age of Months 2, and 4.

Arm type

Active comparator

Investigational medicinal product name

Pentavalent DTwP-HepB-Hib vaccine

Investigational medicinal product code

Other name

SHAN5™

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular dose.

Investigational medicinal product name

Inactivated Poliomyelitis Vaccine (IPV)

Investigational medicinal product code

Other name

IMOVAX Polio

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular dose.

Investigational medicinal product name

Oral bivalent types 1 and 3; Poliomyelitis Vaccine (bOPV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

0.1 mL, oral dose.

Investigational medicinal product name

Human Rotavirus, live attenuated

Investigational medicinal product code

Other name

Rotarix

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

1.5 mL, oral dose.

Investigational medicinal product name

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Investigational medicinal product code

Other name

Prevnar 13®

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular dose.

Number of subjects in period 1	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Started	229	231
Safety Analysis Set (SafAS)	228	231
Completed	225	228
Not completed	4	3
Adverse Event	1	-
Withdrawal by Parent/Guardian	3	3

Period 2 title

Booster Phase (Up to Day 506)

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Booster Phase: Group A: SHAN6/SHAN6

Arm description

Subjects who received vaccination in primary series and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Arm type

Experimental

Investigational medicinal product name

Hexavalent DTwP-HepB-Hib-IPV vaccine

Investigational medicinal product code

Other name

SHAN6™

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, dose.

Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6

Arm description

Subjects who received vaccination in primary phase and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Arm type

Active comparator

Investigational medicinal product name

Hexavalent DTwP-HepB-Hib-IPV vaccine

Investigational medicinal product code

Other name

SHAN6™

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular dose.

Number of subjects in period 2 ^[1]	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Started	210	211
Safety Analysis Set (SafAS)	166 ^[2]	167 ^[3]
Completed	209	211
Not completed	1	0
Protocol deviation	1	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Subjects who completed safety follow-up period and entered the booster phase.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: SafAS for booster phase included randomised subjects who received the SHAN6 booster vaccination. Subjects who received Licensed vaccine were not counted in this analysis.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: SafAS for booster phase included randomised subjects who received the SHAN6 booster vaccination. Subjects who received Licensed vaccine were not counted in this analysis.

Baseline characteristics

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Reporting group title

Primary Phase: Group A: SHAN6

Reporting group description

Reporting group title

Primary Phase: Group B: SHAN 5 + bOPV + IPV

Reporting group description

Reporting group values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV	Total
Number of subjects	229	231	460
Age categorical
Units: Subjects
Age continuous
Units: weeks
arithmetic mean (standard deviation)	9.00 ± 0.925	9.03 ± 0.923	-
Gender categorical
Units: Subjects
Female	110	115	225
Male	119	116	235

End points

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Reporting group title

Primary Phase: Group A: SHAN6

Reporting group description

Reporting group title

Primary Phase: Group B: SHAN 5 + bOPV + IPV

Reporting group description

Reporting group title

Booster Phase: Group A: SHAN6/SHAN6

Reporting group description

Subjects who received vaccination in primary series and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Reporting group title

Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6

Reporting group description

Subjects who received vaccination in primary phase and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Primary: Primary Phase: Percentage of Subjects With Vaccine Seroprotection Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

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End point title

Primary Phase: Percentage of Subjects With Vaccine Seroprotection Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

End point description

Seroprotection status for diphtheria, tetanus, hepatitis B (HBs), Hib (PRP) and poliovirus antigens (anti-polio 1, 2, and 3) were defined as following: anti-diphtheria (Anti-D) and anti-tetanus (Anti-T) antibody (Ab) titers greater than or equal to (>=) 0.01 international unit (IU)/mL; Anti-HBs Ab titers >=10 mIU/mL; Anti-PRP Ab titers >= 0.15 micrograms (mcg)/mL; Anti-polio 1, 2, and 3 Ab titers >=8 (1/dilution[dil]). Analysis was performed on per protocol analysis set (PPAS) which was defined as the subset of enrolled subjects who received the 3 doses of the study vaccine without any relevant protocol deviations and had available data at specified time point. Here, 'n'=subjects with available data for each specified category.

End point type

Primary

End point timeframe

28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	217	219
Units: percentage of subjects
number (confidence interval 95%)
Anti-D (n=217, 219)	100 (98.3 to 100)	100 (98.3 to 100)
Anti-T (n=217, 219)	100 (98.3 to 100)	100 (98.3 to 100)
Anti-PRP (n=217, 219)	100 (98.3 to 100)	99.5 (97.5 to 100)
Anti-HBs (n=217, 219)	98.6 (96.0 to 99.7)	98.6 (96.0 to 99.7)
Anti-Polio 1 (n=217, 219)	100 (98.3 to 100)	100 (98.3 to 100)
Anti-Polio 2 (n=216, 219)	100 (98.3 to 100)	98.2 (95.4 to 99.5)
Anti-Polio 3 (n=215, 219)	100 (98.3 to 100)	100 (98.3 to 100)

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-D

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.74

upper limit

1.72

Notes
[1] - Non-inferiority was concluded if the lower limit of 2-sided 95% confidence interval (CI) of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-T

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.74

upper limit

1.72

Notes
[2] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-PRP

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Difference in Percentage

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

-1.32

upper limit

2.54

Notes
[3] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-HBs

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

Parameter type

Difference in Percentage

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-2.77

upper limit

2.72

Notes
[4] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-Polio 1

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

Method

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.74

upper limit

1.72

Notes
[5] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-Polio 2

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Difference in Percentage

Point estimate

1.83

Confidence interval

level

95%

sides

2-sided

lower limit

-0.25

upper limit

4.6

Notes
[6] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-Polio 3

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[7]

Method

Parameter type

Difference in Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.76

upper limit

1.72

Notes
[7] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of difference in percentage between 2 groups was greater than -10%.

Primary: Primary Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens

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End point title

Primary Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens

End point description

Adjusted geometric mean concentrations for anti-pertussis toxin (PT) and anti-fimbriae (FIM) were measured by EU/mL. The adjusted GMCs was computed using analysis of covariance to adjust for baseline disparities and to consider the correlation between pre- and post- concentration, through an Analysis of covariance (ANCOVA) model using the pre-vaccination (Day 0) log-transformed concentration as a covariate for adjustment in order to account for the associated variability. Analysis was performed on PPAS.

End point type

Primary

End point timeframe

28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	217	219
Units: EU/mL
geometric mean (confidence interval 95%)
Anti-PT	44.6 (37.3 to 53.3)	64.7 (54.1 to 77.3)
Anti-FIM	937.3 (807.6 to 1087.7)	1150.4 (992.0 to 1334.2)

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-PT

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[8]

Method

Parameter type

Geometric mean ratio

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.536

upper limit

0.888

Notes
[8] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of ratio between 2 groups was greater than 0.5.

SHAN6 vs SHAN 5 + bOPV + IPV: Anti-FIM

Comparison groups

Primary Phase: Group A: SHAN6 v Primary Phase: Group B: SHAN 5 + bOPV + IPV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[9]

Method

Parameter type

Geometric mean ratio

Point estimate

0.815

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

1.01

Notes
[9] - Non-inferiority was concluded if the lower limit of 2-sided 95% CI of ratio between 2 groups was greater than 0.5.

Secondary: Primary Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

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End point title

Primary Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

End point description

Antibody titers above the following cut-off for each antigen were defined as: Anti-D Ab titers >= 0.01 IU/mL, >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-T Ab titers >= 0.01 IU/mL, >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-HBs Ab titers >=10 mIU/mL and >= 100 mIU/mL; Anti-PRP Ab titers >= 0.15 mcg/mL and >=1.0 mcg/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Analysis was performed on full analysis set (FAS) population defined as subset of enrolled subjects who received at least 1 dose of the study vaccine. Here, ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: percentage of subjects
number (confidence interval 95%)
Anti-D: Day 0: >=0.01 (n=228,231)	95.2 (91.5 to 97.6)	95.2 (91.6 to 97.6)
Anti-D: Day 0: >=0.1 (n=228,231)	56.1 (49.4 to 62.7)	51.1 (44.4 to 57.7)
Anti-D: Day 0: >=1.0 (n=228,231)	5.3 (2.7 to 9.0)	2.6 (1.0 to 5.6)
Anti-D: Post-dose 3: >=0.01 (n=225,227)	100 (98.4 to 100)	100 (98.4 to 100)
Anti-D: Post-dose 3: >=0.1 (n=225,227)	99.1 (96.8 to 99.9)	100 (98.4 to 100)
Anti-D: Post-dose 3: >=1.0 (n=225,227)	81.8 (76.1 to 86.6)	85.5 (80.2 to 89.8)
Anti-T: Day 0: >=0.01 (n=228,231)	100 (98.4 to 100)	100 (98.4 to 100)
Anti-T: Day 0: >=0.1 (n=228,231)	99.1 (96.9 to 99.9)	97.4 (94.4 to 99.0)
Anti-T: Day 0: >=1.0 (n=228,231)	66.7 (60.1 to 72.8)	62.3 (55.7 to 68.6)
Anti-T: Post-dose 3: >=0.01 (n=225,227)	100 (98.4 to 100)	100 (98.4 to 100)
Anti-T: Post-dose 3: >=0.1 (n=225,227)	100 (98.4 to 100)	100 (98.4 to 100)
Anti-T: Post-dose 3: >=1.0 (n=225,227)	96.4 (93.1 to 98.5)	97.4 (94.3 to 99.0)
Anti-HBs: Day 0: >=10 (n=227,229)	27.8 (22.0 to 34.1)	25.3 (19.8 to 31.5)
Anti-HBs: Day 0: >=100 (n=227,229)	10.6 (6.9 to 15.3)	6.6 (3.7 to 10.6)
Anti-HBs: Post-dose 3: >=10 (n=225,227)	98.7 (96.2 to 99.7)	98.2 (95.5 to 99.5)
Anti-HBs: Post-dose 3: >=100 (n=225,227)	93.8 (89.8 to 96.6)	96.5 (93.2 to 98.5)
Anti-PRP: Day 0: >=0.15 (n=227,229)	30.0 (24.1 to 36.4)	27.5 (21.8 to 33.8)
Anti-PRP: Day 0: >=1.0 (n=227,229)	3.5 (1.5 to 6.8)	2.6 (1.0 to 5.6)
Anti-PRP: Post-dose 3: >=0.15 (n=225,227)	100 (98.4 to 100)	99.6 (97.6 to 100)
Anti-PRP: Post-dose 3: >=1.0 (n=225,227)	96.4 (93.1 to 98.5)	94.7 (90.9 to 97.2)
Anti-Polio 1: Day 0: >=8 (n=228,231)	42.5 (36.0 to 49.2)	48.9 (42.3 to 55.6)
Anti-Polio 1: Post-dose 3: >=8 (n=225,227)	100 (98.4 to 100)	100 (98.4 to 100)
Anti-Polio 2: Day 0: >=8 (n=225,228)	57.8 (51.0 to 64.3)	53.9 (47.2 to 60.5)
Anti-Polio 2: Post-dose 3: >=8 (n=224,227)	100 (98.4 to 100)	97.8 (94.9 to 99.3)
Anti-Polio 3: Day 0: >=8 (n=228,230)	29.4 (23.6 to 35.8)	34.8 (28.6 to 41.3)
Anti-Polio 3: Post-dose 3: >=8 (n=223,227)	100 (98.4 to 100)	100 (98.4 to 100)

No statistical analyses for this end point

Secondary: Primary Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens

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End point title

Primary Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens

End point description

Pertussis antigens vaccine response status for anti-PT, anti-FHA, anti-pertactin (PRN), and anti-FIM Abs was defined as follows: post-dose 3 vaccination concentration greater than or equal to (>=) 4*lower limit of quantitation (LLOQ) of the assay, if the pre-vaccination concentration was less than (<) 4*LLOQ of the assay or; post-dose 3 vaccination concentration >= the pre-vaccination concentration, if the pre-vaccination concentration was >= 4*LLOQ of the assay. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	225	227
Units: percentage of subjects
number (confidence interval 95%)
Anti-PT	62.2 (55.5 to 68.6)	69.2 (62.7 to 75.1)
Anti-FIM	94.7 (90.9 to 97.2)	95.2 (91.5 to 97.6)
Anti-PRN	72.4 (66.1 to 78.2)	80.6 (74.9 to 85.5)
Anti-FHA	56.0 (49.2 to 62.6)	67.0 (60.4 to 73.0)

No statistical analyses for this end point

Secondary: Primary Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens

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End point title

Primary Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens

End point description

Pertussis antigens vaccine seroconversion for anti-PT, anti-FHA, anti-PRN, and anti-FIM Abs were defined as follows: a >= 4-fold rise in the respective PT, FHA, PRN, FIM Ab concentration between pre-dose 1 (Day 0) and post-dose 3 (Day 148). Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

pre-dose 1 up to 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	225	227
Units: percentage of subjects
number (confidence interval 95%)
Anti-PT	53.3 (46.6 to 60.0)	60.4 (53.7 to 66.8)
Anti-FIM	89.3 (84.5 to 93.0)	93.0 (88.8 to 95.9)
Anti-PRN	64.0 (57.4 to 70.3)	71.8 (65.5 to 77.6)
Anti-FHA	36.9 (30.6 to 43.6)	48.0 (41.4 to 54.7)

No statistical analyses for this end point

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens

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End point title

Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens

End point description

Antibodies to Diphtheria, Tetanus, Pertussis, PRN, FIM and FHA were measured by chemiluminescent method; Anti-HBs by enzyme-linked immunosorbent assay (ELISA); Anti-PRP by polyribosyl-ribitol phosphate Radioimmune assay (PRP-RIA); Poliovirus types 1, 2, and 3 by micro metabolic Inhibition Testing (MIT). Geometric mean Concentrations (GMCs) of antibodies against various antigens were measured in terms of: Anti-D and Anti-T Ab titers: IU/mL; Anti-PT, Anti-FIM, Anti-PRN, Anti-FHA: EU/mL; Anti-HBs Ab titers: mIU/mL; Anti-PRP Ab titer: mcg/mL; and Anti-polio 1, 2, and 3 Ab titers: 1/dilution. GMCRs were calculated as the ratio of GMCs post vaccination (i.e., on Day 148) and pre-vaccination on Day 0. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e. Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	225	227
Units: ratio
geometric mean (confidence interval 95%)
Anti-D (n=225,227)	17.8 (13.9 to 22.8)	22.0 (17.2 to 28.2)
Anti-T (n=225,227)	3.35 (2.84 to 3.96)	3.71 (3.10 to 4.43)
Anti-PT (n=225,227)	6.13 (4.04 to 9.30)	10.1 (6.72 to 15.1)
Anti-FIM (n=225,227)	81.0 (60.2 to 109)	105 (79.0 to 140)
Anti-PRN (n=225,227)	6.11 (4.78 to 7.81)	9.69 (7.49 to 12.5)
Anti-FHA (n=225,227)	2.01 (1.50 to 2.68)	3.64 (2.68 to 4.95)
Anti-PRP (n=224,225)	204 (159 to 262)	156 (125 to 195)
Anti-HBs (n=224,225)	267 (203 to 350)	343 (267 to 441)
Anti-Polio 1 (n=225,227)	340 (271 to 426)	225 (189 to 269)
Anti-Polio 2 (n=221,224)	246 (201 to 301)	6.42 (5.27 to 7.82)
Anti-Polio 3 (n=223,226)	576 (483 to 686)	237 (202 to 277)

No statistical analyses for this end point

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

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End point title

Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

End point description

Anti-Rotavirus antibodies were detected by IgA enzyme immunoassay and Anti-Streptococcus pneumoniae antibodies (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were detected by pneumococcal capsular polysaccharide (PnPS) immunoglobulin G (IgG) electrochemiluminescence (ECL) assay in human serum. GMCs of antibodies against anti-rotavirus antigens were measured in terms of U/mL and for pneumococcal serotypes in terms of mcg/mL. GMCRs were calculated as the ratio of GMCs post vaccination (i.e., on Day 148) and pre-vaccination on Day 0. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	111	114
Units: ratio
geometric mean (confidence interval 95%)
Anti-rotavirus (n=111,110)	20.8 (15.4 to 28.2)	17.1 (12.2 to 23.9)
Anti- pneumococcal serotype 1 (n=111, 114)	26.8 (22.1 to 32.5)	25.3 (19.6 to 32.7)
Anti- pneumococcal serotype 3 (n=111,114)	8.51 (7.25 to 10.0)	7.54 (6.47 to 8.78)
Anti- pneumococcal serotype 4 (n=111,114)	25.0 (21.0 to 29.7)	26.9 (23.1 to 31.2)
Anti- pneumococcal serotype 5 (n=111,114)	25.5 (20.7 to 31.4)	26.1 (21.5 to 31.6)
Anti- pneumococcal serotype 6A (n=111,114)	31.3 (23.6 to 41.4)	32.2 (25.5 to 40.6)
Anti- pneumococcal serotype 6B (n=111,114)	14.9 (11.2 to 19.9)	17.1 (12.8 to 22.8)
Anti- pneumococcal serotype 7F (n=111,114)	32.2 (27.4 to 37.8)	29.3 (24.1 to 35.7)
Anti- pneumococcal serotype 9V (n=111,114)	23.7 (19.6 to 28.6)	20.0 (15.8 to 25.3)
Anti- pneumococcal serotype 14 (n=110,113)	12.2 (8.79 to 17.1)	13.5 (9.63 to 18.9)
Anti- pneumococcal serotype 18C (n=111,114)	16.1 (12.9 to 20.2)	17.2 (14.0 to 21.2)
Anti- pneumococcal serotype 19A (n=111,114)	15.4 (11.8 to 20.1)	16.3 (12.6 to 20.9)
Anti- pneumococcal serotype 19F (n=111,114)	28.9 (22.2 to 37.8)	29.7 (22.6 to 38.9)
Anti- pneumococcal serotype 23F (n=111,114)	13.6 (10.2 to 17.9)	13.4 (10.3 to 17.6)

No statistical analyses for this end point

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens

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End point title

Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens

End point description

Antibodies to Diphtheria, Tetanus, Pertussis, PRN, FIM and FHA were measured by chemiluminescent method; Anti-HBs by ELISA assay method; Anti-PRP by PRP-RIA; Poliovirus types 1, 2, and 3 by MIT. GMCs of antibodies against various antigens were measured in terms of: Anti-D and Anti-T Ab titers: IU/mL; Anti-PT, Anti-FIM, Anti-PRN, Anti-FHA: EU/mL; Anti-HBs Ab titers: mIU/mL; Anti-PRP Ab titer: mcg/mL; and Anti-polio 1, 2, and 3 Ab titers: 1/dilution. Analysis was performed on FAS population. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: concentrations
geometric mean (confidence interval 95%)
Anti-D: Day 0 (n=228,231)	0.104 (0.087 to 0.123)	0.095 (0.080 to 0.113)
Anti-D: Post-dose 3 (n=225,227)	1.85 (1.65 to 2.08)	2.09 (1.89 to 2.31)
Anti-T: Day 0 (n=228,231)	1.37 (1.20 to 1.56)	1.21 (1.04 to 1.40)
Anti-T: Post-dose 3 (n=225,227)	4.55 (4.14 to 5.01)	4.46 (4.07 to 4.90)
Anti-PT: Day 0 (n=228,231)	6.81 (5.47 to 8.48)	6.50 (5.26 to 8.04)
Anti-PT: Post-dose 3 (n=225,227)	42.0 (33.2 to 53.0)	64.6 (51.3 to 81.4)
Anti-FIM: Day 0 (n=228,231)	11.2 (9.16 to 13.8)	10.9 (9.01 to 13.3)
Anti-FIM: Post-dose 3 (n=225,227)	924 (796 to 1071)	1153 (982 to 1355)
Anti-PRN: Day 0 (n=228,231)	3.63 (2.92 to 4.50)	4.06 (3.22 to 5.11)
Anti-PRN: Post-dose 3 (n=225,227)	21.9 (18.6 to 25.8)	39.4 (34.3 to 45.1)
Anti-FHA: Day 0 (n=228,231)	21.0 (16.7 to 26.5)	26.0 (20.5 to 32.9)
Anti-FHA: Post-dose 3 (n=225,227)	42.4 (37.9 to 47.4)	92.8 (83.3 to 103)
Anti-PRP: Day 0 (n=227,229)	0.077 (0.064 to 0.092)	0.072 (0.061 to 0.085)
Anti-PRP: Post-dose 3 (n=225,227)	15.5 (13.3 to 18.0)	11.2 (9.56 to 13.1)
Anti-HBs: Day 0 (n=227,229)	6.71 (5.47 to 8.23)	5.91 (4.94 to 7.08)
Anti-HBs: Post-dose 3 (n=225,227)	1768 (1414 to 2210)	2034 (1649 to 2508)
Anti-Polio 1: Day 0 (n=228,231)	6.54 (5.59 to 7.64)	6.66 (5.84 to 7.59)
Anti-Polio 1: Post-dose 3 (n=225,227)	2205 (1936 to 2511)	1511 (1320 to 1731)
Anti-Polio 2: Day 0 (n=225,228)	9.32 (8.03 to 10.8)	8.03 (6.92 to 9.31)
Anti-Polio 2: Post-dose 3 (n=224,227)	2336 (2068 to 2639)	52.1 (46.4 to 58.5)
Anti-Polio 3: Day 0 (n=228,230)	5.41 (4.85 to 6.03)	5.97 (5.37 to 6.64)
Anti-Polio 3: Post-dose 3 (n=223,227)	3063 (2679 to 3502)	1413 (1251 to 1597)

No statistical analyses for this end point

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

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End point title

Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

End point description

Anti-Rotavirus antibodies were detected by IgA enzyme immunoassay and Anti-Streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies were detected by PnPS IgG ECL assay in human serum. GMCs of antibodies against anti-rotavirus antigens were measured in terms of U/mL and for pneumococcal serotypes in terms of mcg/mL. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	114	115
Units: concentrations
geometric mean (confidence interval 95%)
Anti-rotavirus: Day 0 (n=113,114)	3.88 (3.75 to 4.01)	4.01 (3.77 to 4.27)
Anti-rotavirus: Post-dose 3 (n=114,111)	78.8 (58.3 to 106)	69.7 (50.0 to 97.3)
Serotype 1: Day 0 (n=112,115)	0.150 (0.130 to 0.174)	0.151 (0.126 to 0.180)
Serotype 1: Post-dose 3 (n=111,115)	4.06 (3.51 to 4.70)	3.86 (3.31 to 4.50)
Serotype 3: Day 0 (n=112,115)	0.103 (0.092 to 0.115)	0.097 (0.088 to 0.108)
Serotype 3: Post-dose 3 (n=111,115)	0.879 (0.785 to 0.984)	0.739 (0.665 to 0.821)
Serotype 4: Day 0 (n=112,115)	0.098 (0.088 to 0.110)	0.092 (0.083 to 0.102)
Serotype 4: Post-dose 3 (n=111,115)	2.46 (2.20 to 2.76)	2.50 (2.25 to 2.78)
Serotype 5: Day 0 (n=112,115)	0.115 (0.100 to 0.132)	0.115 (0.100 to 0.132)
Serotype 5: Post-dose 3 (n=111,115)	2.92 (2.54 to 3.37)	3.02 (2.65 to 3.45)
Serotype 6A: Day 0 (n=112,115)	0.168 (0.137 to 0.205)	0.173 (0.145 to 0.208)
Serotype 6A: Post-dose 3 (n=111,115)	5.29 (4.54 to 6.16)	5.68 (4.90 to 6.59)
Serotype 6B: Day 0 (n=112,115)	0.150 (0.126 to 0.179)	0.155 (0.130 to 0.184)
Serotype 6B: Post-dose 3 (n=111,115)	2.26 (1.80 to 2.83)	2.69 (2.20 to 3.29)
Serotype 7F: Day 0 (n=112,115)	0.130 (0.114 to 0.148)	0.134 (0.115 to 0.155)
Serotype 7F: Post-dose 3 (n=111,115)	4.18 (3.77 to 4.64)	3.95 (3.55 to 4.40)
Serotype 9V: Day 0 (n=112,115)	0.138 (0.119 to 0.160)	0.149 (0.127 to 0.175)
Serotype 9V: Post-dose 3 (n=111,115)	3.28 (2.89 to 3.72)	2.96 (2.59 to 3.40)
Serotype 14: Day 0 (n=111,114)	0.935 (0.729 to 1.20)	0.850 (0.666 to 1.09)
Serotype 14: Post-dose 3 (n=111,115)	11.4 (9.71 to 13.3)	11.5 (9.68 to 13.6)
Serotype 18C: Day 0 (n=112,115)	0.185 (0.155 to 0.222)	0.174 (0.149 to 0.204)
Serotype 18C: Post-dose 3 (n=111,115)	3.01 (2.68 to 3.39)	3.00 (2.67 to 3.37)
Serotype 19A: Day 0 (n=112,115)	0.227 (0.188 to 0.275)	0.219 (0.181 to 0.265)
Serotype 19A: Post-dose 3 (n=111,115)	3.51 (3.06 to 4.04)	3.63 (3.16 to 4.17)
Serotype 19F: Day 0 (n=112,115)	0.198 (0.162 to 0.243)	0.191 (0.158 to 0.232)
Serotype 19F: Post-dose 3 (n=111,115)	5.79 (5.12 to 6.54)	5.74 (4.83 to 6.82)
Serotype 23F: Day 0 (n=112,115)	0.172 (0.142 to 0.207)	0.189 (0.154 to 0.232)
Serotype 23F: Post-dose 3 (n=111,115)	2.34 (1.97 to 2.80)	2.55 (2.19 to 2.98)

No statistical analyses for this end point

Secondary: Primary Phase: Percentage of Subjects With >=4-fold Rise Against Anti-rotavirus Antibody Titers

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End point title

Primary Phase: Percentage of Subjects With >=4-fold Rise Against Anti-rotavirus Antibody Titers

End point description

Anti-Rotavirus antibodies were detected by IgA enzyme immunoassay. Percentage of subjects with >= 4-fold rise in serum IgA anti-rotavirus Ab titers were reported in this endpoint. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	111	110
Units: percentage of subjects
number (confidence interval 95%)	83.8 (75.6 to 90.1)	79.1 (70.3 to 86.3)

No statistical analyses for this end point

Secondary: Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers Greater than or equal to (>=) 0.35 mcg/mL

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End point title

Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers Greater than or equal to (>=) 0.35 mcg/mL

End point description

Anti-Streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies were detected by PnPS IgG ECL assay in human serum. GMCs of antibodies against anti-rotavirus antigens were measured in terms of U/mL and for pneumococcal serotypes in terms of mcg/mL. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Day 0 (pre-vaccination) and 28 days post third dose (i.e., Day 148)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	112	115
Units: percentage of subjects
number (confidence interval 95%)
Serotype 1: Day 0 (n=112,115)	17.9 (11.3 to 26.2)	19.1 (12.4 to 27.5)
Serotype 1: Post-dose 3 (n=111,115)	100 (96.7 to 100)	99.1 (95.3 to 100)
Serotype 3: Day 0 (n=112,115)	8.9 (4.4 to 15.8)	3.5 (1.0 to 8.7)
Serotype 3: Post-dose 3 (n=111,115)	94.6 (88.6 to 98.0)	94.8 (89.0 to 98.1)
Serotype 4: Day 0 (n=112,115)	5.4 (2.0 to 11.3)	5.2 (1.9 to 11.0)
Serotype 4: Post-dose 3 (n=111,115)	100 (96.7 to 100)	100 (96.8 to 100)
Serotype 5: Day 0 (n=112,115)	13.4 (7.7 to 21.1)	11.3 (6.2 to 18.6)
Serotype 5: Post-dose 3 (n=111,115)	98.2 (93.6 to 99.8)	100 (96.8 to 100)
Serotype 6A: Day 0 (n=112,115)	25.0 (17.3 to 34.1)	20.0 (13.1 to 28.5)
Serotype 6A: Post-dose 3 (n=111,115)	99.1 (95.1 to 100)	99.1 (95.3 to 100)
Serotype 6B: Day 0 (n=112,115)	17.9 (11.3 to 26.2)	18.3 (11.7 to 26.5)
Serotype 6B: Post-dose 3 (n=111,115)	91.0 (84.1 to 95.6)	95.7 (90.1 to 98.6)
Serotype 7F: Day 0 (n=112,115)	8.0 (3.7 to 14.7)	13.0 (7.5 to 20.6)
Serotype 7F: Post-dose 3 (n=111,115)	100 (96.7 to 100)	100 (96.8 to 100)
Serotype 9V: Day 0 (n=112,115)	16.1 (9.8 to 24.2)	17.4 (11.0 to 25.6)
Serotype 9V: Post-dose 3 (n=111,115)	100 (96.7 to 100)	99.1 (95.3 to 100)
Serotype 14: Day 0 (n=111,114)	80.2 (71.5 to 87.1)	78.1 (69.4 to 85.3)
Serotype 14: Post-dose 3 (n=111,115)	100 (96.7 to 100)	100 (96.8 to 100)
Serotype 18C: Day 0 (n=112,115)	24.1 (16.5 to 33.1)	23.5 (16.1 to 32.3)
Serotype 18C: Post-dose 3 (n=111,115)	100 (96.7 to 100)	100 (96.8 to 100)
Serotype 19A: Day 0 (n=112,115)	30.4 (22.0 to 39.8)	35.7 (26.9 to 45.1)
Serotype 19A: Post-dose 3 (n=111,115)	100 (96.7 to 100)	100 (96.8 to 100)
Serotype 19F: Day 0 (n=112,115)	28.6 (20.4 to 37.9)	30.4 (22.2 to 39.7)
Serotype 19F: Post-dose 3 (n=111,115)	100 (96.7 to 100)	98.3 (93.9 to 99.8)
Serotype 23F: Day 0 (n=112,115)	26.8 (18.9 to 36.0)	27.8 (19.9 to 37.0)
Serotype 23F: Post-dose 3 (n=111,115)	98.2 (93.6 to 99.8)	98.3 (93.9 to 99.8)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens Following Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens Following Booster Vaccination

End point description

Antibody titers above the following cut-off for each antigen were defined as: Anti-D Ab titers >= 0.01 IU/mL, >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-T Ab titers >= 0.01 IU/mL, >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-HBs Ab titers >=10 mIU/mL and >= 100 mIU/mL; Anti-PRP Ab titers >= 0.15 mcg/mL and >=1.0 mcg/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Analysis was performed on FAS for booster defined as the subset of randomised subjects who received the SHAN6 booster vaccination. Here, ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Pre-booster and 28 days after the booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: percentage of subjects
number (confidence interval 95%)
Anti-D: Pre-booster: >=0.01 (n=166,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-D: Pre-booster: >=0.1 (n=166,167)	92.8 (87.7 to 96.2)	91.0 (85.6 to 94.9)
Anti-D: Pre-booster: >=1 (n=166,167)	16.3 (11.0 to 22.8)	24.6 (18.2 to 31.8)
Anti-D: Post-booster: >=0.01 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-D: Post-booster: >=0.1 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-D: Post-booster: >=1 (n=165,167)	98.8 (95.7 to 99.9)	100 (97.8 to 100)
Anti-T: Pre-booster: >=0.01 (n=166,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-T: Pre-booster: >=0.1 (n=166,167)	98.8 (95.7 to 99.9)	98.8 (95.7 to 99.9)
Anti-T: Pre-booster: >=1 (n=166,167)	41.0 (33.4 to 48.9)	44.9 (37.2 to 52.8)
Anti-T: Post-booster: >=0.01 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-T: Post-booster: >=0.1 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-T: Post-booster: >=1 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-HBs: Pre-booster: >=10 (n=166,167)	86.1 (79.9 to 91.0)	91.6 (86.3 to 95.3)
Anti-HBs: Pre-booster: >=100 (n=166,167)	53.6 (45.7 to 61.4)	63.5 (55.7 to 70.8)
Anti-HBs: Post-booster: >=10 (n=164,167)	98.8 (95.7 to 99.9)	98.8 (95.7 to 99.9)
Anti-HBs: Post-booster: >=100 (n=164,167)	97.6 (93.9 to 99.3)	97.6 (94.0 to 99.3)
Anti-PRP: Pre-booster: >=0.15 (n=166,166)	93.4 (88.5 to 96.6)	95.2 (90.7 to 97.9)
Anti-PRP: Pre-booster: >=1.0 (n=166,166)	74.7 (67.4 to 81.1)	75.9 (68.7 to 82.2)
Anti-PRP: Post-booster: >=0.15 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-PRP: Post-booster: >=1.0 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-Polio 1: Pre-booster: >=8 (n=166,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-Polio 1: Post-booster: >=8 (n=165,166)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-Polio 2: Pre-booster: >=8 (n=166,167)	100 (97.8 to 100)	99.4 (96.7 to 100)
Anti-Polio 2: Post-booster: >=8 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)
Anti-Polio 3: Pre-booster: >=8 (n=166,167)	98.8 (95.7 to 99.9)	100 (97.8 to 100)
Anti-Polio 3: Post-booster: >=8 (n=165,167)	100 (97.8 to 100)	100 (97.8 to 100)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens Following Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens Following Booster Vaccination

End point description

Booster vaccine response for anti-PT, anti-FHA, anti-PRN, and anti-FIM Abs was defined as follows: post-booster vaccination concentration >=4*the pre-booster concentration of the assay, if the pre-booster concentration is < 4*LLOQ of the assay or post-booster vaccination concentration >=2*the pre-booster concentration, if the pre-booster concentration is >=4*LLOQ of the assay. Analysis was performed on FAS for booster phase. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

28 days after the booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	165	167
Units: percentage of subjects
number (confidence interval 95%)
Anti-PT	92.1 (86.9 to 95.7)	89.8 (84.2 to 94.0)
Anti-FIM	100 (97.8 to 100)	98.2 (94.8 to 99.6)
Anti-PRN	90.3 (84.7 to 94.4)	96.4 (92.3 to 98.7)
Anti-FHA	97.0 (93.1 to 99.0)	98.8 (95.7 to 99.9)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens Following Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens Following Booster Vaccination

End point description

Pertussis antigens seroconversion status for anti-PT, anti-FHA, anti-PRN, and anti-FIM Abs defined as follows: a >= 4-fold rise in the respective PT, FHA, PRN, FIM Ab concentration between pre-booster and post-booster. Analysis was performed on FAS population for booster phase. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

pre-booster up to 28 days after the booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	165	167
Units: percentage of subjects
number (confidence interval 95%)
Anti-PT	89.7 (84.0 to 93.9)	83.8 (77.4 to 89.1)
Anti-FIM	98.2 (94.8 to 99.6)	86.2 (80.1 to 91.1)
Anti-PRN	92.1 (86.9 to 95.7)	96.4 (92.3 to 98.7)
Anti-FHA	96.4 (92.3 to 98.7)	93.4 (88.5 to 96.7)

No statistical analyses for this end point

Secondary: Booster Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens Following Booster Vaccination

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End point title

Booster Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens Following Booster Vaccination

End point description

Antibodies to Diphtheria, Tetanus, PT, PRN, FIM and FHA were measured by chemiluminescent method; Anti-HBs by ELISA; Anti-PRP by PRP-RIA; Poliovirus types 1, 2, and 3 by MIT. GMCs of antibodies against various antigens were measured in terms of: Anti-D and Anti-T Ab titers: IU/mL; Anti-PT, Anti-FIM, Anti-PRN, Anti-FHA: EU/mL; Anti-HBs Ab titers: mIU/mL; Anti-PRP Ab titer: mcg/mL; and Anti-polio 1, 2, and 3 Ab titers: 1/dilution. GMCRs were calculated as the ratio of GMCs post booster (i.e., on Day 388-478 and Day 416-506) and pre-booster. Analysis was performed on FAS population for booster phase. Here, ‘n’ = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Pre-booster and 28 days after the booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: ratio
geometric mean (confidence interval 95%)
Anti-D (n=165,167)	14.8 (13.1 to 16.6)	14.2 (12.5 to 16.0)
Anti-T (n=165,167)	17.7 (16.0 to 19.6)	17.1 (15.5 to 18.8)
Anti-PT (n=165,167)	13.3 (11.5 to 15.5)	8.80 (7.74 to 10.0)
Anti-FIM (n=165,167)	13.9 (12.3 to 15.8)	10.1 (8.86 to 11.4)
Anti-PRN (n=165,167)	14.8 (12.8 to 17.1)	16.2 (14.5 to 18.2)
Anti-FHA (n=165,167)	12.7 (11.4 to 14.0)	9.91 (9.09 to 10.8)
Anti-PRP (n=165,166)	30.4 (24.9 to 37.3)	26.1 (21.7 to 31.6)
Anti-HBs (n=164,167)	51.5 (42.3 to 62.8)	39.1 (32.0 to 47.7)
Anti-Polio 1 (n=165,166)	13.1 (11.0 to 15.6)	5.11 (4.31 to 6.05)
Anti-Polio 2 (n=165,167)	17.6 (15.0 to 20.7)	37.0 (31.2 to 43.9)
Anti-Polio 3 (n=165,167)	21.6 (17.7 to 26.3)	8.32 (6.94 to 9.97)

No statistical analyses for this end point

Secondary: Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens Following Booster Vaccination

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End point title

Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens Following Booster Vaccination

End point description

Antibodies to Diphtheria, Tetanus, Pertussis, PRN, FIM and FHA were measured by chemiluminescent method; Anti-HBs by ELISA; Anti-PRP by PRP-RIA; Poliovirus types 1, 2, and 3 by MIT. GMCs of antibodies against various antigens were measured in terms of: Anti-D and Anti-T Ab titers: IU/mL; Anti-PT, Anti-FIM, Anti-PRN, Anti-FHA: EU/mL; Anti-HBs Ab titers: mIU/mL; Anti-PRP Ab titer: mcg/mL; and Anti-polio 1, 2, and 3 Ab titers: 1/dilution. Analysis was performed on FAS for booster phase. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Pre-booster and 28 days post-booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: concentrations
geometric mean (confidence interval 95%)
Anti-D: Pre-booster (n=166,167)	0.403 (0.348 to 0.468)	0.472 (0.403 to 0.553)
Anti-D: Post-booster (n=165,167)	5.95 (5.34 to 6.64)	6.69 (6.07 to 7.37)
Anti-T: Pre-booster (n=166,167)	0.803 (0.711 to 0.906)	0.816 (0.723 to 0.921)
Anti-T: Post-booster (n=165,167)	14.2 (12.9 to 15.7)	13.9 (12.7 to 15.3)
Anti-PT: Pre-booster (n=166,167)	6.48 (5.15 to 8.16)	11.1 (8.78 to 13.9)
Anti-PT: Post-booster (n=165,167)	87.5 (71.0 to 108)	97.4 (79.6 to 119)
Anti-FIM: Pre-booster (n=166,167)	86.6 (72.3 to 104)	122 (101 to 148)
Anti-FIM: Post-booster (n=165,167)	1213 (1068 to 1377)	1230 (1064 to 1422)
Anti-PRN: Pre-booster (n=166,167)	2.86 (2.44 to 3.36)	5.01 (4.25 to 5.92)
Anti-PRN: Post-booster (n=165,167)	42.2 (34.6 to 51.4)	81.4 (68.8 to 96.3)
Anti-FHA: Pre-booster (n=166,167)	6.82 (5.94 to 7.82)	16.2 (14.2 to 18.5)
Anti-FHA: Post-booster (n=165,167)	86.5 (74.6 to 100)	161 (143 to 181)
Anti-PRP: Pre-booster (n=166,166)	2.21 (1.73 to 2.83)	2.28 (1.81 to 2.87)
Anti-PRP: Post-booster (n=165,167)	69.1 (58.9 to 81.1)	59.7 (51.5 to 69.3)
Anti-HBs: Pre-booster (n=166,167)	110 (80.8 to 149)	165 (125 to 218)
Anti-HBs: Post-booster (n=164,167)	5604 (4258 to 7375)	6449 (5048 to 8239)
Anti-Polio 1: Pre-booster (n=166,167)	252 (209 to 303)	556 (476 to 650)
Anti-Polio 1: Post-booster (n=165,166)	3320 (2948 to 3739)	2825 (2516 to 3171)
Anti-Polio 2: Pre-booster (n=166,167)	304 (255 to 364)	97.3 (83.1 to 114)
Anti-Polio 2: Post-booster (n=165,167)	5348 (4637 to 6169)	3601 (3150 to 4117)
Anti-Polio 3: Pre-booster (n=166,167)	236 (188 to 297)	562 (482 to 656)
Anti-Polio 3: Post-booster (n=165,167)	5117 (4400 to 5952)	4678 (4155 to 5266)

No statistical analyses for this end point

Secondary: Booster Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens Following Booster Vaccination

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End point title

Booster Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens Following Booster Vaccination

End point description

Adjusted geometric mean concentrations for anti-PT, anti-FIM, anti-PRN and anti-FHA were measured by EU/mL. The adjusted GMCs was computed using analysis of covariance to adjust for baseline disparities and to consider the correlation between pre- and post- concentration, through an ANCOVA model using the pre-vaccination (Day 0) log-transformed concentration as a covariate for adjustment in order to account for the associated variability. Analysis was performed on FAS for booster phase.

End point type

Secondary

End point timeframe

28 days after the booster dose (at Day 416-506)

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: EU/mL
geometric mean (confidence interval 95%)
Anti-PT	105.5 (93.1 to 119.5)	81.0 (71.5 to 91.7)
Anti-FIM	1328.6 (1211.1 to 1457.5)	1124.5 (1025.6 to 1232.9)
Anti-PRN	53.2 (46.7 to 60.5)	64.8 (57.0 to 73.6)
Anti-FHA	119.6 (108.9 to 131.3)	116.8 (106.5 to 128.2)

No statistical analyses for this end point

Secondary: Primary Phase: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

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End point title

Primary Phase: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

End point description

An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessarily had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All subjects were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Analysis was performed on safety analysis set (SafAS) that included subjects who had received at least one dose of the study vaccine and were analysed according to the actual treatment received.

End point type

Secondary

End point timeframe

Within 30 minutes post-vaccination

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: subjects
number (not applicable)	0	0

No statistical analyses for this end point

Secondary: Primary Phase: Number of Subjects Reporting Solicited Injection Site Reactions

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End point title

Primary Phase: Number of Subjects Reporting Solicited Injection Site Reactions

End point description

A solicited reaction (SR) was an expected adverse reaction (AR) observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included injection site tenderness, erythema and site swelling. Analysis was performed on SafAS. Here, 'n' = subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Within 7 days after any and each vaccination (Vaccination 1, 2, 3)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: subjects
number (not applicable)
Tenderness: Post any vaccination (n=228,230)	210	202
Tenderness: Post vaccination 1 (n=228,230)	174	168
Tenderness: Post vaccination 2 (n=225,228)	180	150
Tenderness: Post vaccination 3 (n=225,228)	168	155
Erythema: Post any vaccination (n=228,230)	128	100
Erythema: Post vaccination 1 (n=228,230)	80	71
Erythema: Post vaccination 2 (n=225,228)	82	52
Erythema: Post vaccination 3 (n=225,228)	73	51
Swelling: Post any vaccination (n=228,230)	98	89
Swelling: Post vaccination 1 (n=228,230)	62	70
Swelling: Post vaccination 2 (n=225,228)	55	43
Swelling: Post vaccination 3 (n=225,228)	49	42

No statistical analyses for this end point

Secondary: Primary Phase: Number of Subjects With Solicited Systemic Reactions

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End point title

Primary Phase: Number of Subjects With Solicited Systemic Reactions

End point description

SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability. Analysis was performed on SafAS. Here, 'n' =subjects with available data for each specified category.

End point type

Secondary

End point timeframe

Within 7 days after any and each vaccination (Vaccination 1, 2, 3)

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: subjects
number (not applicable)
Fever: Post any vaccination (n=228,230)	157	130
Fever: Post vaccination 1 (n=228,230)	97	73
Fever: Post vaccination 2 (n=225,228)	100	69
Fever: Post vaccination 3 (n=225,228)	92	65
Vomiting: Post any vaccination (n=228,230)	75	67
Vomiting: Post vaccination 1 (n=228,230)	40	38
Vomiting: Post vaccination 2 (n=225,228)	31	32
Vomiting: Post vaccination 3 (n=225,228)	43	21
Crying abnormal: Post any vaccination (n=228,230)	206	207
Crying abnormal: Post vaccination 1 (n=228,230)	176	165
Crying abnormal: Post vaccination 2 (n=225,228)	171	154
Crying abnormal: Post vaccination 3 (n=225,228)	159	140
Drowsiness: Post any vaccination (n=228,230)	183	189
Drowsiness: Post vaccination 1 (n=228,230)	148	143
Drowsiness: Post vaccination 2 (n=225,228)	133	124
Drowsiness: Post vaccination 3 (n=225,228)	116	113
Appetite lost: Post any vaccination (n=228,230)	141	114
Appetite lost: Post vaccination 1 (n=228,230)	97	78
Appetite lost: Post vaccination 2 (n=225,228)	69	56
Appetite lost: Post vaccination 3 (n=225,228)	74	51
Irritability: Post any vaccination (n=228,230)	196	193
Irritability: Post vaccination 1 (n=228,230)	162	159
Irritability: Post vaccination 2 (n=225,228)	144	127
Irritability: Post vaccination 3 (n=225,228)	143	124

No statistical analyses for this end point

Secondary: Primary Phase: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

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End point title

Primary Phase: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

End point description

End point type

Secondary

End point timeframe

From Day 0 up to Day 28 post-vaccination

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: subjects
number (not applicable)	44	45

No statistical analyses for this end point

Secondary: Primary Phase: Number of Subjects Reporting Serious Adverse Events (SAEs)

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End point title

Primary Phase: Number of Subjects Reporting Serious Adverse Events (SAEs)

End point description

An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessarily had to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. Analysis was performed on SafAS.

End point type

Secondary

End point timeframe

From Baseline up to Day 148 post-vaccination

End point values	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV
Number of subjects analysed	228	231
Units: subjects
number (not applicable)	19	17

No statistical analyses for this end point

Secondary: Booster Phase: Number of Subjects Reporting Immediate Unsolicited AEs Following Booster Vaccination

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End point title

Booster Phase: Number of Subjects Reporting Immediate Unsolicited AEs Following Booster Vaccination

End point description

An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessarily had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. All subjects were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Analysis was performed on SafAS for booster phase defined as the subset of randomised subjects who received the SHAN6 booster vaccination.

End point type

Secondary

End point timeframe

Within 30 minutes post-vaccination

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: subjects
number (not applicable)	0	0

No statistical analyses for this end point

Secondary: Booster Phase: Number of Subjects Reporting Solicited Injection Site Reactions Following Booster Vaccination

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End point title

Booster Phase: Number of Subjects Reporting Solicited Injection Site Reactions Following Booster Vaccination

End point description

A SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included injection site tenderness, erythema and site swelling. Analysis was performed on SafAS for booster phase.

End point type

Secondary

End point timeframe

Within 7 days post-vaccination

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: subjects
number (not applicable)
Tenderness: Post any vaccination	126	122
Erythema: Post any vaccination	45	49
Swelling: Post any vaccination	40	40

No statistical analyses for this end point

Secondary: Booster Phase: Number of Subjects With Solicited Systemic Reactions Following Booster Vaccination

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End point title

Booster Phase: Number of Subjects With Solicited Systemic Reactions Following Booster Vaccination

End point description

End point type

Secondary

End point timeframe

Within 7 days post-vaccination

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: subjects
number (not applicable)
Fever	55	53
Vomiting	15	16
Crying abnormal	110	104
Drowsiness	85	91
Appetite lost	75	72
Irritability	105	103

No statistical analyses for this end point

Secondary: Booster Phase: Number of Subjects Reporting Unsolicited AEs Following Booster Vaccination

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End point title

Booster Phase: Number of Subjects Reporting Unsolicited AEs Following Booster Vaccination

End point description

End point type

Secondary

End point timeframe

From Day 0 up to Day 28 post-vaccination

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: subjects
number (not applicable)	7	7

No statistical analyses for this end point

Secondary: Booster Phase: Number of Subjects Reporting Serious Adverse Events (SAEs) Following Booster Vaccination

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End point title

Booster Phase: Number of Subjects Reporting Serious Adverse Events (SAEs) Following Booster Vaccination

End point description

An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessarily had to have a causal relationship with treatment. An SAE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. Analysis was performed on SafAS for booster phase.

End point type

Secondary

End point timeframe

From Day 148 up to Day 506 post booster injection

End point values	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Number of subjects analysed	166	167
Units: subjects
number (not applicable)	5	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Unsolicited non-serious AEs: Day 0 to Day 28 post any vaccination SR: within 7 post any vaccination; SAE: up to Day 148 for primary phase; up to Day 506 for booster phase

Adverse event reporting additional description

Analysed on SafAS. SR was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Primary Phase: Group A: SHAN6

Reporting group description

Subjects aged 2 months (at the time of enrollment) received SHAN6 vaccine at the age of Months 2, 4, and 6, co-administered with Prevnar 13 vaccine at the age of Months 2, 4, and 6; and Rotarix (Rotavirus) vaccine at the age of Months 2, and 4.

Reporting group title

Primary Phase: Group B: SHAN 5 + bOPV + IPV

Reporting group description

Reporting group title

Booster Phase: Group A: SHAN6/SHAN6

Reporting group description

Subjects who received vaccination in primary series and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Reporting group title

Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6

Reporting group description

Subjects who received vaccination in primary phase and completed the safety follow-up period received a booster injection of SHAN6 in the booster phase at 15-18 months of age.

Serious adverse events	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 228 (8.33%)	17 / 231 (7.36%)	5 / 166 (3.01%)	2 / 167 (1.20%)
number of deaths (all causes)	1	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Arthropod Bite
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Kawasaki's Disease
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Febrile Convulsion
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	1 / 167 (0.60%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Food Allergy
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Urticaria
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 166 (0.60%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Covid-19
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	3 / 166 (1.81%)	1 / 167 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dengue Fever
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated Bacillus Calmette-Guerin Infection
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema Subitum
subjects affected / exposed	0 / 228 (0.00%)	2 / 231 (0.87%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	1 / 166 (0.60%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis Viral
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Pneumonia Respiratory Syncytial Viral
subjects affected / exposed	5 / 228 (2.19%)	2 / 231 (0.87%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia Viral
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis Acute
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory Syncytial Virus Bronchiolitis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory Tract Infection Viral
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urethritis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary Tract Infection
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral Rash
subjects affected / exposed	1 / 228 (0.44%)	1 / 231 (0.43%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral Upper Respiratory Tract Infection
subjects affected / exposed	2 / 228 (0.88%)	0 / 231 (0.00%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Primary Phase: Group A: SHAN6	Primary Phase: Group B: SHAN 5 + bOPV + IPV	Booster Phase: Group A: SHAN6/SHAN6	Booster Phase: Group B: SHAN 5+bOPV+IPV/SHAN6
Total subjects affected by non serious adverse events
subjects affected / exposed	226 / 228 (99.12%)	227 / 231 (98.27%)	149 / 166 (89.76%)	151 / 167 (90.42%)
Nervous system disorders
Somnolence
subjects affected / exposed	183 / 228 (80.26%)	189 / 231 (81.82%)	85 / 166 (51.20%)	91 / 167 (54.49%)
occurrences all number	397	380	85	91
General disorders and administration site conditions
Crying
subjects affected / exposed	206 / 228 (90.35%)	207 / 231 (89.61%)	110 / 166 (66.27%)	104 / 167 (62.28%)
occurrences all number	506	459	110	104
Injection Site Erythema
Additional description: Erythema events that occurred after 7 days post-vaccination were considered as unsolicited AE.
subjects affected / exposed	128 / 228 (56.14%)	103 / 231 (44.59%)	45 / 166 (27.11%)	49 / 167 (29.34%)
occurrences all number	235	217	45	49
Injection Site Pain
Additional description: Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE.
subjects affected / exposed	210 / 228 (92.11%)	203 / 231 (87.88%)	126 / 166 (75.90%)	122 / 167 (73.05%)
occurrences all number	522	625	126	122
Injection Site Swelling
Additional description: Swelling events that occurred after 7 days post-vaccination were considered as unsolicited AE.
subjects affected / exposed	98 / 228 (42.98%)	91 / 231 (39.39%)	40 / 166 (24.10%)	40 / 167 (23.95%)
occurrences all number	166	193	40	40
Pyrexia
subjects affected / exposed	157 / 228 (68.86%)	130 / 231 (56.28%)	55 / 166 (33.13%)	53 / 167 (31.74%)
occurrences all number	290	207	55	53
Gastrointestinal disorders
Vomiting
subjects affected / exposed	75 / 228 (32.89%)	67 / 231 (29.00%)	15 / 166 (9.04%)	16 / 167 (9.58%)
occurrences all number	114	91	15	16
Psychiatric disorders
Irritability
subjects affected / exposed	196 / 228 (85.96%)	193 / 231 (83.55%)	105 / 166 (63.25%)	103 / 167 (61.68%)
occurrences all number	449	410	105	103
Infections and infestations
Nasopharyngitis
subjects affected / exposed	20 / 228 (8.77%)	18 / 231 (7.79%)	0 / 166 (0.00%)	0 / 167 (0.00%)
occurrences all number	24	23	0	0
Metabolism and nutrition disorders
Decreased Appetite
subjects affected / exposed	141 / 228 (61.84%)	114 / 231 (49.35%)	75 / 166 (45.18%)	72 / 167 (43.11%)
occurrences all number	240	185	75	72

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Were there any global substantial amendments to the protocol? Yes

15 Apr 2020

Following changes were made: Updated product number; Updated manufacturer, Global Safety Officer, and Clinical Trial Manager information; updated version number and date; minor editorial changes; updated history of protocol version; updated synopsis text that all subjects included in each group will be randomised in 1:1 ratio to be tested at Day (D) 0 and D148 (+14 days) to assess their immune responses against either PCV or ORV antigens; addition of a benefit vaccine to the study in order to complete the PCV vaccination schedule as requested by the Ethics Committee; clarified that AESIs should only be reported as SAEs if they are assessed as serious based on the ICH seriousness criteria; added text in secondary endpoints, immunogenicity endpoints: geometric mean concentration ratio (GMCR) (post booster/pre booster) of individual Ab concentration for all Abs, Ab concentration for each antigen; Updated that SHAN6 would be provided in the study either as a multi dose formulation or as a single dose formulation; clarified the injection route of IMOVAX; clarified the injection route of Prevnar 13; updated exclusion criteria and statistical methods; update the document with the conclusions of SHAN600002 study; updated background of the Investigational product; updated study design and visit procedures; updated study calendar; updated that SHAN6 will be provided in the study either as a multi dose formulation or as a single dose formulation; updated correction of the injection route for IPV vaccine; clarified subject number allocation; clarified LLOQ and ULOQ values for anti-Poliovirus antibody assay; clarified intensity scales used in the CRB and/or the diary card; updated standard case definitions from Brighton Collaboration are also used for encephalopathy and ELS; correction of the time window; updated determination of sample size and power calculation and reference list.

18 Feb 2021

Following changes were made: suppression of one product number (518); only multidose to be used and the address of the single dose manufacturer was removed; updated first page, history of protocol versions; version number and approval date update; planned study period and study calendar updated to reflect the new study period following change in subjects’ age for booster vaccination; updated study design, duration of participation in the study, and table of study to reflect that booster dose would be administered between the age of 15-18 months old and that subjects coming back for booster vaccination before end of September 2021 would receive SHAN6 as a booster vaccine and subjects coming back after end of September 2021 would receive a licensed vaccine as booster dose; updated Form, composition and batch number of investigational/study product; updated text for IMOVAX Polio and Prevnar 13; updated text for SH600003 study with the main conclusions from the study; typos corrected throughout the document.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (SHAN6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Primary Phase: Percentage of Subjects With Vaccine Seroprotection Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

Primary: Primary Phase: Percentage of Subjects With Vaccine Seroprotection Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

Primary: Primary Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens

Primary: Primary Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens

Secondary: Primary Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

Secondary: Primary Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens

Secondary: Primary Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens

Secondary: Primary Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens

Secondary: Primary Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens

Secondary: Primary Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

Secondary: Primary Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against Anti-rotavirus and Anti-S. pneumoniae Antigens

Secondary: Primary Phase: Percentage of Subjects With >=4-fold Rise Against Anti-rotavirus Antibody Titers

Secondary: Primary Phase: Percentage of Subjects With >=4-fold Rise Against Anti-rotavirus Antibody Titers

Secondary: Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers Greater than or equal to (>=) 0.35 mcg/mL

Secondary: Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers Greater than or equal to (>=) 0.35 mcg/mL

Secondary: Booster Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens Following Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib [PRP]) and Poliovirus (Polio) Antigens Following Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens Following Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Vaccine Response Against Pertussis Antigens Following Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens Following Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Vaccine Seroconversion Against Pertussis Antigens Following Booster Vaccination

Secondary: Booster Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens Following Booster Vaccination

Secondary: Booster Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against all the Antigens Following Booster Vaccination

Secondary: Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens Following Booster Vaccination

Secondary: Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against all the Antigens Following Booster Vaccination

Secondary: Booster Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens Following Booster Vaccination

Secondary: Booster Phase: Adjusted Geometric Mean Concentrations (aGMCs) of Antibodies Against Pertussis Antigens Following Booster Vaccination

Secondary: Primary Phase: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

Secondary: Primary Phase: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

Secondary: Primary Phase: Number of Subjects Reporting Solicited Injection Site Reactions

Secondary: Primary Phase: Number of Subjects Reporting Solicited Injection Site Reactions

Secondary: Primary Phase: Number of Subjects With Solicited Systemic Reactions

Secondary: Primary Phase: Number of Subjects With Solicited Systemic Reactions

Secondary: Primary Phase: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Secondary: Primary Phase: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Secondary: Primary Phase: Number of Subjects Reporting Serious Adverse Events (SAEs)

Secondary: Primary Phase: Number of Subjects Reporting Serious Adverse Events (SAEs)

Secondary: Booster Phase: Number of Subjects Reporting Immediate Unsolicited AEs Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Immediate Unsolicited AEs Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Solicited Injection Site Reactions Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Solicited Injection Site Reactions Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects With Solicited Systemic Reactions Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects With Solicited Systemic Reactions Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Unsolicited AEs Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Unsolicited AEs Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Serious Adverse Events (SAEs) Following Booster Vaccination

Secondary: Booster Phase: Number of Subjects Reporting Serious Adverse Events (SAEs) Following Booster Vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (SHAN6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand