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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

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    Trial identification
    Sponsor protocol code
    SH600009
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04429295
    WHO universal trial number (UTN)
    U1111-1233-9694
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 460
    Worldwide total number of subjects
    460
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    460
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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.

    Pre-assignment
    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
    Period 1 title
    Primary Phase (Up to Day 148)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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.

    Arm title
    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
         Withdrawal by Parent/Guardian
    3
    3
         Adverse Event
    1
    -
    Period 2
    Period 2 title
    Booster Phase (Up to Day 506)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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.

    Arm title
    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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    Baseline characteristics reporting groups
    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 (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.

    Reporting group title
    Primary Phase: Group B: SHAN 5 + bOPV + IPV
    Reporting group 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.

    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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    End points reporting groups
    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 (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.

    Reporting group title
    Primary Phase: Group B: SHAN 5 + bOPV + IPV
    Reporting group 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.
    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)
    Statistical analysis title
    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
    0
    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%.
    Statistical analysis title
    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
    0
    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%.
    Statistical analysis title
    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%.
    Statistical analysis title
    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%.
    Statistical analysis title
    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
    0
    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%.
    Statistical analysis title
    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%.
    Statistical analysis title
    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
    0
    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)
    Statistical analysis title
    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.
    Statistical analysis title
    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
    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. Analysis was performed on SafAS.
    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
    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 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)
        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
    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. Analysis was performed on SafAS for booster phase.
    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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    Adverse events information
    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 used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    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
    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 (Rotavirus) vaccine at the age of Months 2, and 4.

    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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