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    Clinical Trial Results:
    Safety and Immunogenicity Study of Full Schedule (3-Dose of SHAN6™) or SHAN6™-SHAN5®-SHAN6™ Versus the Licensed Vaccine SHAN5® With bOPV and IPV When Administered Per National Immunization Schedule in Healthy Kenyan Infants

    Summary
    EudraCT number
    		 2022-003923-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2023
    First version publication date
    29 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SH600008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1217-1674
    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
    22 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The first primary objective was to demonstrate the non-inferiority of SHAN6™ compared to the licensed control vaccines SHAN 5® (+ bivalent oral polio vaccine [bOPV] + inactivated polio vaccine [IPV]) with respect to the adjusted geometric mean concentration (aGMC) ratio for anti-pertussis toxoid (PT) and anti-fimbriae (FIM) for pertussis and seroprotection rates for all other antigens 28 days after a 3 dose primary series (6, 10 and 14 weeks). If the first objective was reached, the second primary objective was to demonstrate the non-inferiority of mixed schedule administration of SHAN6™ and SHAN 5® (+ bOPV) compared to SHAN 5® (+bOPV + IPV) as a 3 dose primary series with respect to the aGMC ratio for anti-PT and anti-FIM for pertussis and seroprotection rates for all other antigens 28 days after a 3 dose primary series.
    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
    13 Oct 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
    Kenya: 690
    Worldwide total number of subjects
    690
    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)
    690
    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
    		 Study was conducted at 6 active sites in Kenya. A total of 690 subjects were enrolled and vaccinated in the study from 13 October 2022 to 05 May 2021.

    Pre-assignment
    Screening details
    		 The study was planned to be conducted in two periods: primary phase and booster phase. Due to unavailability of investigational and control vaccines, study was early terminated. Due to early termination of the study, booster phase was not conducted, hence no booster vaccination was administered to the subjects.

    Period 1
    Period 1 title
    Primary Phase (Up to Day 84) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A: SHAN6
    Arm description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine, co-administered with pneumococcal conjugate vaccine (PCV) and oral rotavirus vaccine (ORV) vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.
    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 millilitres (mL), intramuscular dose.

    Investigational medicinal product name
    Rotavirus, live attenuated (ORV)
    Investigational medicinal product code
    Other name
    RotaTeq®
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL, oral dose.

    Investigational medicinal product name
    Pneumococcal polysaccharide conjugate vaccine (PCV)
    Investigational medicinal product code
    Other name
    Synflorix®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular dose.

    Arm title
    		 Group B: SHAN6/SHAN 5+bOPV/SHAN6
    Arm description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine at the age of 6 to 8 weeks, along with SHAN5 + bOPV at the age of 10 to 12 weeks and SHAN6 at the age of 14-16 weeks, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.
    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.

    Investigational medicinal product name
    Rotavirus, live attenuated (ORV)
    Investigational medicinal product code
    Other name
    RotaTeq®
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL, oral dose.

    Investigational medicinal product name
    Pneumococcal polysaccharide conjugate vaccine (PCV)
    Investigational medicinal product code
    Other name
    Synflorix®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular dose.

    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
    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.

    Arm title
    		 Group C: SHAN 5 + bOPV + IPV
    Arm description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN5+bOPV vaccine, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks and IPV at 14 to 16 weeks in the primary phase of the study.
    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
    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
    Rotavirus, live attenuated (ORV)
    Investigational medicinal product code
    Other name
    RotaTeq®
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL, oral dose.

    Investigational medicinal product name
    Pneumococcal polysaccharide conjugate vaccine (PCV)
    Investigational medicinal product code
    Other name
    Synflorix®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular dose.

    Investigational medicinal product name
    Inactivated polio vaccine
    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.

    Number of subjects in period 1
    		Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Started
    228
    231
    231
    Safety Analysis Set (SafAS)
    227
    229
    231
    Completed
    215
    211
    217
    Not completed
    13
    20
    14
         Adverse event
    -
    1
    1
         Lost to follow-up
    1
    3
    2
         Withdrawal by parent/guardian
    8
    8
    7
         Protocol deviation
    4
    8
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A: SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine, co-administered with pneumococcal conjugate vaccine (PCV) and oral rotavirus vaccine (ORV) vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group B: SHAN6/SHAN 5+bOPV/SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine at the age of 6 to 8 weeks, along with SHAN5 + bOPV at the age of 10 to 12 weeks and SHAN6 at the age of 14-16 weeks, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group C: SHAN 5 + bOPV + IPV
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN5+bOPV vaccine, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks and IPV at 14 to 16 weeks in the primary phase of the study.

    Reporting group values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV Total
    Number of subjects
    		 228 231 231 690
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 45.0 ( 3.30 ) 44.9 ( 3.01 ) 45.2 ( 3.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 123 108 112 343
        Male
    		 105 123 119 347

    End points

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    End points reporting groups
    Reporting group title
    Group A: SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine, co-administered with pneumococcal conjugate vaccine (PCV) and oral rotavirus vaccine (ORV) vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group B: SHAN6/SHAN 5+bOPV/SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine at the age of 6 to 8 weeks, along with SHAN5 + bOPV at the age of 10 to 12 weeks and SHAN6 at the age of 14-16 weeks, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group C: SHAN 5 + bOPV + IPV
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN5+bOPV vaccine, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks and IPV at 14 to 16 weeks in the primary phase of the study.

    Primary: Primary Phase: Percentage of Subjects With Vaccine Seroprotection Against Diphtheria (D), Tetanus (T), Hepatitis B (Hep B), Haemophilus Influenzae Type b (Hib Polyribosyl Ribitol Phosphate [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 Polyribosyl Ribitol Phosphate [PRP]) and Poliovirus (Polio) Antigens [1]
    End point description
    Seroprotection status for diphtheria, tetanus, hepatitis B (HBs), Hib (PRP) and poliovirus antigens (antipolio 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 milli-international units (mUI)/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 at least 1 dose 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 84)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Group B was not analysed, which is in accordance with the design of the study as pre-specified in the protocol.
    End point values
    		 Group A: SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    193
    188
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-D (n=193,188)
    100 (98.1 to 100)
    100 (98.1 to 100)
        Anti-T (n=193,188)
    100 (98.1 to 100)
    100 (98.1 to 100)
        Anti-HBs (n=191,184)
    95.3 (91.2 to 97.8)
    92.9 (88.2 to 96.2)
        Anti-PRP (n=191,186)
    99.5 (97.1 to 100)
    100 (98.0 to 100)
        Anti-Polio 1 (n=192,187)
    99.5 (97.1 to 100)
    99.5 (97.1 to 100)
        Anti-Polio 2 (n=191,184)
    99.5 (97.1 to 100)
    97.8 (94.5 to 99.4)
        Anti-Polio 3 (n=191,185)
    99.0 (96.3 to 99.9)
    100 (98.0 to 100)
    Statistical analysis title
    		 Anti-D: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    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
    		 -1.95
         upper limit
    		 2
    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
    		 Anti-T: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 2
    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
    		 Anti-HBs: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group C: SHAN 5 + bOPV + IPV v Group A: SHAN6
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.58
         upper limit
    		 7.5
    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
    		 Anti-PRP: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 1.55
    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
    		 Anti-Polio 1: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.48
    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
    		 Anti-Polio 2: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 4.96
    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%.
    Statistical analysis title
    		 Anti-Polio 3: SHAN6 vs SHAN5+bOP+IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.74
         upper limit
    		 1.12
    Notes
    [8] - 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 [9]
    End point description
    Adjusted geometric mean concentrations for anti-pertussis toxin (PT) and anti-fimbriae (FIM) were measured by endotoxin units per millilitre (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 84)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for Group B was not analysed, which is in accordance with the design of the study as pre-specified in the protocol.
    End point values
    		 Group A: SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    193
    188
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    38.9 (30.8 to 49.0)
    61.0 (48.2 to 77.2)
        Anti-FIM
    809 (662 to 990)
    1055 (860 to 1294)
    Statistical analysis title
    		 Anti-PT: SHAN6 vs SHAN 5 + bOPV + IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.637
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.457
         upper limit
    		 0.886
    Notes
    [10] - 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
    		 Anti-FIM: SHAN6 vs SHAN 5 + bOPV + IPV
    Comparison groups
    Group A: SHAN6 v Group C: SHAN 5 + bOPV + IPV
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.767
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.576
         upper limit
    		 1.02
    Notes
    [11] - 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 (HBs), 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 (HBs), 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/dil). Analysis was performed on FAS population which was defined as the 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    227
    229
    231
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-D: Day 0: >=0.01 (n=221,221,222)
    81.0 (75.2 to 85.9)
    80.5 (74.7 to 85.5)
    83.3 (77.8 to 88.0)
        Anti-D: Day 0: >=0.1 (n=221,221,222)
    47.5 (40.8 to 54.3)
    49.8 (43.0 to 56.6)
    48.6 (41.9 to 55.4)
        Anti-D: Day 0: >=1 (n=221,221,222)
    8.6 (5.3 to 13.1)
    12.7 (8.6 to 17.8)
    10.4 (6.7 to 15.1)
        Anti-D: Post-dose 3: >=0.01 (n=211,209,215)
    100 (98.3 to 100)
    100 (98.3 to 100)
    100 (98.3 to 100)
        Anti-D: Post-dose 3: >=0.1 (n=211,209,215)
    98.6 (95.9 to 99.7)
    99.0 (96.6 to 99.9)
    100 (98.3 to 100)
        Anti-D: Post-dose 3: >=1 (n=211,209,215)
    75.4 (69.0 to 81.0)
    72.7 (66.2 to 78.6)
    82.3 (76.6 to 87.2)
        Anti-T: Day 0: >=0.01 (n=221,221,222)
    100 (98.3 to 100)
    100 (98.3 to 100)
    100 (98.4 to 100)
        Anti-T: Day 0: >=0.1 (n=221,221,222)
    99.1 (96.8 to 99.9)
    98.6 (96.1 to 99.7)
    98.6 (96.1 to 99.7)
        Anti-T: Day 0: >=1 (n=221,221,222)
    79.2 (73.2 to 84.3)
    77.4 (71.3 to 82.7)
    81.1 (75.3 to 86.0)
        Anti-T: Post-dose 3: >=0.01 (n=211,209,215)
    100 (98.3 to 100)
    100 (98.3 to 100)
    100 (98.3 to 100)
        Anti-T: Post-dose 3: >=0.1 (n=211,209,215)
    100 (98.3 to 100)
    100 (98.3 to 100)
    100 (98.3 to 100)
        Anti-T: Post-dose 3: >=1 (n=211,209,215)
    96.2 (92.7 to 98.3)
    95.7 (92.0 to 98.0)
    96.7 (93.4 to 98.7)
        Anti-HBs: Day 0: >=10 (n=211,208,215)
    9.0 (5.5 to 13.7)
    10.6 (6.7 to 15.6)
    10.7 (6.9 to 15.6)
        Anti-HBs: Day 0: >=100 (n=211,208,215)
    4.3 (2.0 to 7.9)
    7.7 (4.5 to 12.2)
    3.3 (1.3 to 6.6)
        Anti-HBs: Post-Dose 3: >=10 (n=209,208,210)
    94.7 (90.8 to 97.3)
    94.7 (90.7 to 97.3)
    92.4 (87.9 to 95.6)
        Anti-HBs: Post-Dose 3: >=100 (n=209,208,210)
    79.4 (73.3 to 84.7)
    88.0 (82.8 to 92.1)
    81.9 (76.0 to 86.9)
        Anti-PRP: Day 0: >=0.15 (n=207,211,208)
    29.5 (23.4 to 36.2)
    24.2 (18.6 to 30.5)
    23.1 (17.5 to 29.4)
        Anti-PRP: Day 0: >=1 (n=207,211,208)
    4.8 (2.3 to 8.7)
    4.7 (2.3 to 8.5)
    4.3 (2.0 to 8.1)
        Anti-PRP: Post-dose 3: >=0.15 (n=209,207,213)
    99.5 (97.4 to 100)
    99.5 (97.3 to 100)
    100 (98.3 to 100)
        Anti-PRP: Post-dose 3: >=1 (n=209,207,213)
    94.7 (90.8 to 97.3)
    94.2 (90.1 to 97.0)
    93.0 (88.7 to 96.0)
        Anti-Polio 1: Day 0: >=8 (n=216,219,221)
    85.6 (80.3 to 90.0)
    84.9 (79.5 to 89.4)
    84.6 (79.2 to 89.1)
        Anti-Polio 1: Post-dose 3: >=8 (n=210,209,214)
    99.5 (97.4 to 100)
    99.5 (97.4 to 100)
    99.5 (97.4 to 100)
        Anti-Polio 2: Day 0: >=8 (n=212,217,215)
    64.6 (57.8 to 71.0)
    57.6 (50.7 to 64.3)
    58.1 (51.2 to 64.8)
        Anti-Polio 2: Post-dose 3: >=8 (n=209,208,211)
    99.0 (96.6 to 99.9)
    98.6 (95.8 to 99.7)
    98.1 (95.2 to 99.5)
        Anti-Polio 3: Day 0: >=8 (n=212,216,214)
    70.8 (64.1 to 76.8)
    62.5 (55.7 to 69.0)
    65.4 (58.6 to 71.8)
        Anti-Polio 3: Post-dose 3: >=8 (n=209,205,212)
    99.0 (96.6 to 99.9)
    100 (98.2 to 100)
    100 (98.3 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-filamentous hemagglutinin (anti-FHA), anti-pertactin (PRN), and anti-FIM Abs was defined as follows: post-dose 3 vaccination concentration >= 4*lower limit of quantification (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 with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    28 days post third dose (i.e., Day 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    206
    201
    206
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-PT
    68.0 (61.1 to 74.3)
    70.6 (63.8 to 76.8)
    75.2 (68.8 to 81.0)
        Anti-FIM
    94.7 (90.6 to 97.3)
    98.5 (95.7 to 99.7)
    97.1 (93.8 to 98.9)
        Anti-PRN
    82.0 (76.1 to 87.0)
    91.0 (86.2 to 94.6)
    91.7 (87.1 to 95.1)
        Anti-FHA
    53.4 (46.3 to 60.4)
    56.7 (49.6 to 63.7)
    78.6 (72.4 to 84.0)
    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 84). Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Pre-dose up to 28 days post third dose (i.e., Day 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    206
    201
    206
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-PT
    61.2 (54.1 to 67.9)
    61.7 (54.6 to 68.4)
    67.0 (60.1 to 73.4)
        Anti-FIM
    92.7 (88.3 to 95.9)
    97.5 (94.3 to 99.2)
    95.6 (91.9 to 98.0)
        Anti-PRN
    79.6 (73.5 to 84.9)
    86.1 (80.5 to 90.5)
    87.4 (82.1 to 91.6)
        Anti-FHA
    27.7 (21.7 to 34.3)
    37.3 (30.6 to 44.4)
    49.5 (42.5 to 56.5)
    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, PT, PRN, FIM and FHA were measured by Multiplexed Electro 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/dil. GMCRs were calculated as the ratio of GMCs post vaccination (i.e., on Day 84) and pre-vaccination on Day 0. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects with available data 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    206
    201
    206
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-D (n=206,201,206)
    27.6 (18.6 to 40.9)
    21.5 (14.2 to 32.5)
    29.5 (20.7 to 41.9)
        Anti-T (n=206,201,206)
    1.75 (1.41 to 2.16)
    1.74 (1.40 to 2.15)
    2.18 (1.76 to 2.71)
        Anti-PT (n=206,201,206)
    10.9 (7.45 to 15.8)
    10.4 (7.20 to 14.9)
    12.4 (8.78 to 17.6)
        Anti-FIM (n=206,201,206)
    167 (122 to 228)
    253 (191 to 337)
    207 (153 to 280)
        Anti-PRN (n=206,201,206)
    18.5 (14.4 to 23.8)
    23.9 (18.8 to 30.2)
    30.9 (24.7 to 38.6)
        Anti-FHA (n=206,201,206)
    1.73 (1.40 to 2.15)
    2.03 (1.63 to 2.52)
    3.92 (3.15 to 4.87)
        Anti-PRP (n=191,191,191)
    89.9 (70.4 to 115)
    87.3 (66.7 to 114)
    93.0 (73.1 to 118)
        Anti-HBs (n=195,189,196)
    87.3 (64.1 to 119)
    161 (114 to 227)
    94.7 (69.3 to 130)
        Anti-Polio 1 (n=200,199,204)
    28.9 (22.5 to 37.1)
    24.2 (19.3 to 30.3)
    24.3 (19.1 to 30.9)
        Anti-Polio 2 (n=195,196,198)
    47.7 (34.1 to 66.7)
    69.2 (46.6 to 103)
    8.97 (6.88 to 11.7)
        Anti-Polio 3 (n=197,194,196)
    71.8 (52.6 to 98.2)
    62.6 (44.9 to 87.3)
    49.5 (37.0 to 66.3)
    No statistical analyses for this end point

    Secondary: Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-Streptococcus Pneumoniae Antigens

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    End point title
    		 Primary Phase: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Anti-rotavirus and Anti-Streptococcus Pneumoniae Antigens
    End point description
    Anti-Rotavirus antibodies were detected by IgA enzyme immunoassay and Anti-Streptococcus pneumoniae antibodies (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 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 pneumococcal serotypes in terms of mcg/mL. GMCRs were calculated as the ratio of GMCs post vaccination (i.e., on Day 84) and pre-vaccination on Day 0. Analysis was performed on FAS population. Here, ‘number of subjects analysed’ = subjects with available data 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    93
    92
    94
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-rotavirus (n=86,91,88)
    13.8 (9.02 to 21.1)
    11.7 (7.78 to 17.7)
    9.59 (6.32 to 14.6)
        Anti-pneumococcal serotype 1 (n=93,92,94)
    28.6 (23.0 to 35.5)
    26.4 (20.9 to 33.3)
    27.8 (21.4 to 36.2)
        Anti-pneumococcal serotype 4 (n=93,92,94)
    29.0 (24.2 to 34.8)
    26.0 (20.6 to 32.8)
    26.8 (21.0 to 34.3)
        Anti-pneumococcal serotype 5 (n=93,92,94)
    23.6 (19.2 to 29.0)
    24.1 (19.9 to 29.1)
    21.3 (16.1 to 28.2)
        Anti-pneumococcal serotype 6B (n=93,92,94)
    17.7 (12.5 to 25.1)
    16.2 (11.5 to 23.0)
    15.4 (10.6 to 22.3)
        Anti-pneumococcal serotype 7F (n=93,92,94)
    22.2 (17.6 to 28.0)
    25.0 (19.6 to 31.8)
    28.0 (21.9 to 35.8)
        Anti-pneumococcal serotype 9V (n=93,92,94)
    22.5 (18.2 to 27.8)
    18.3 (14.4 to 23.1)
    20.0 (15.6 to 25.5)
        Anti-pneumococcal serotype 14 (n=92,91,94)
    7.97 (5.46 to 11.6)
    5.41 (3.66 to 8.01)
    5.86 (4.01 to 8.57)
        Anti-pneumococcal serotype 18C (n=93,92,94)
    21.2 (16.0 to 28.0)
    15.2 (11.1 to 20.7)
    26.2 (19.4 to 35.4)
        Anti-pneumococcal serotype 19F (n=93,92,94)
    11.4 (8.22 to 15.9)
    10.1 (6.90 to 14.9)
    11.3 (8.04 to 15.8)
        Anti-pneumococcal serotype 23F (n=93,92,94)
    9.63 (7.16 to 12.9)
    8.21 (6.01 to 11.2)
    7.71 (5.40 to 11.0)
    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 multiplexed electro 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, ‘number of subjects analysed’ = subjects with available data 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    221
    221
    222
    Units: concentrations
    geometric mean (confidence interval 95%)
        Anti-D: Day 0 (n=221,221,222)
    0.070 (0.053 to 0.091)
    0.084 (0.063 to 0.111)
    0.081 (0.062 to 0.105)
        Anti-D: Post-dose 3 (n=211,209,215)
    1.92 (1.63 to 2.26)
    1.78 (1.53 to 2.08)
    2.25 (1.99 to 2.56)
        Anti-T: Day 0 (n=221,221,222)
    2.25 (1.96 to 2.59)
    2.18 (1.86 to 2.55)
    2.21 (1.89 to 2.57)
        Anti-T: Post-dose 3 (n=211,209,215)
    3.90 (3.46 to 4.39)
    3.75 (3.34 to 4.21)
    4.73 (4.21 to 5.31)
        Anti-PT: Day 0 (n=221,221,222)
    4.11 (3.51 to 4.80)
    4.58 (3.96 to 5.31)
    4.64 (4.03 to 5.34)
        Anti-PT: Post-dose 3 (n=211,209,215)
    43.2 (33.1 to 56.3)
    49.2 (38.0 to 63.8)
    58.5 (46.3 to 74.0)
        Anti-FIM: Day 0 (n=221,221,222)
    4.99 (4.13 to 6.03)
    4.65 (3.87 to 5.59)
    5.34 (4.39 to 6.49)
        Anti-FIM: Post-dose 3 (n=211,209,215)
    831 (667 to 1034)
    1118 (935 to 1338)
    1068 (893 to 1278)
        Anti-PRN: Day 0 (n=221,221,222)
    1.99 (1.75 to 2.27)
    2.52 (2.18 to 2.92)
    2.26 (1.96 to 2.60)
        Anti-PRN: Post-dose 3 (n=211,209,215)
    36.5 (29.4 to 45.5)
    59.5 (50.0 to 70.7)
    69.7 (57.3 to 84.8)
        Anti-FHA: Day 0 (n=221,221,222)
    12.1 (10.7 to 13.7)
    12.6 (11.0 to 14.4)
    12.3 (10.8 to 13.9)
        Anti-FHA: Post-dose 3 (n=211,209,215)
    21.4 (18.5 to 24.8)
    25.7 (22.3 to 29.6)
    47.5 (41.2 to 54.7)
        Anti-PRP: Day 0 (n=207,211,208)
    0.082 (0.068 to 0.098)
    0.078 (0.065 to 0.093)
    0.070 (0.060 to 0.082)
        Anti-PRP: Post-dose 3 (n=209,207,213)
    7.38 (6.36 to 8.56)
    6.97 (5.96 to 8.15)
    6.46 (5.55 to 7.51)
        Anti-HBs: Day 0 (n=211,208,215)
    3.59 (3.06 to 4.21)
    4.12 (3.35 to 5.06)
    3.61 (3.11 to 4.19)
        Anti-HBs: Post-dose 3 (n=209,208,210)
    315 (252 to 395)
    588 (459 to 752)
    359 (277 to 464)
        Anti-Polio 1: Day 0 (n=216,219,221)
    42.7 (34.6 to 52.8)
    42.4 (34.4 to 52.3)
    45.4 (36.3 to 56.9)
        Anti-Polio 1: Post-dose 3 (n=210,209,214)
    1252 (1059 to 1482)
    1105 (953 to 1281)
    1168 (1003 to 1359)
        Anti-Polio 2: Day 0 (n=212,217,215)
    11.6 (9.79 to 13.8)
    10.4 (8.80 to 12.3)
    9.61 (8.22 to 11.2)
        Anti-Polio 2: Post-dose 3 (n=209,208,211)
    562 (462 to 683)
    696 (537 to 902)
    86.2 (73.5 to 101)
        Anti-Polio 3: Day 0 (n=212,216,214)
    34.4 (26.1 to 45.4)
    27.8 (21.1 to 36.7)
    25.4 (19.4 to 33.2)
        Anti-Polio 3: Post-dose 3 (n=209,205,212)
    2244 (1899 to 2652)
    1977 (1718 to 2274)
    1273 (1124 to 1442)
    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, 4, 5, 6B, 7F, 9V, 14, 18C, 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 with available data 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    105
    106
    103
    Units: concentrations
    geometric mean (confidence interval 95%)
        Anti-rotavirus: Day 0 (n=95,98,101)
    4.13 (3.66 to 4.66)
    3.79 (3.72 to 3.86)
    3.96 (3.67 to 4.26)
        Anti-rotavirus: Post-dose 3 (n=99,106,101)
    57.4 (38.6 to 85.4)
    45.3 (31.0 to 66.1)
    39.1 (26.5 to 57.7)
        Serotype 1: Day 0 (n=100,104,103)
    0.100 (0.089 to 0.112)
    0.112 (0.098 to 0.127)
    0.112 (0.099 to 0.128)
        Serotype 1: Post-dose 3 (n=105,100,102)
    2.73 (2.33 to 3.19)
    2.87 (2.42 to 3.40)
    3.15 (2.63 to 3.77)
        Serotype 4: Day 0 (n=100,104,103)
    0.093 (0.084 to 0.102)
    0.112 (0.098 to 0.128)
    0.113 (0.098 to 0.129)
        Serotype 4: Post-dose 3 (n=105,100,102)
    2.67 (2.31 to 3.08)
    2.92 (2.47 to 3.44)
    3.08 (2.57 to 3.70)
        Serotype 5: Day 0 (n=100,104,103)
    0.087 (0.080 to 0.094)
    0.084 (0.078 to 0.090)
    0.095 (0.085 to 0.106)
        Serotype 5: Post-dose 3 (n=105,100,102)
    1.98 (1.67 to 2.34)
    2.00 (1.70 to 2.37)
    2.06 (1.68 to 2.52)
        Serotype 6B: Day 0 (n=100,104,103)
    0.111 (0.095 to 0.129)
    0.136 (0.116 to 0.160)
    0.140 (0.119 to 0.165)
        Serotype 6B: Post-dose 3 (n=105,100,102)
    1.92 (1.48 to 2.49)
    2.22 (1.72 to 2.88)
    2.15 (1.60 to 2.88)
        Serotype 7F: Day 0 (n=100,104,103)
    0.128 (0.109 to 0.149)
    0.130 (0.109 to 0.154)
    0.129 (0.110 to 0.151)
        Serotype 7F: Post-dose 3 (n=105,100,102)
    2.87 (2.50 to 3.30)
    3.33 (2.88 to 3.84)
    3.75 (3.24 to 4.34)
        Serotype 9V: Day 0 (n=100,104,103)
    0.145 (0.122 to 0.172)
    0.160 (0.135 to 0.190)
    0.153 (0.131 to 0.178)
        Serotype 9V: Post-dose 3 (n=105,100,102)
    3.11 (2.71 to 3.56)
    2.99 (2.59 to 3.45)
    3.17 (2.72 to 3.71)
        Serotype 14: Day 0 (n=100,103,103)
    0.889 (0.713 to 1.11)
    1.12 (0.902 to 1.40)
    1.10 (0.879 to 1.37)
        Serotype 14: Post-dose 3 (n=104,100,102)
    6.71 (5.38 to 8.35)
    6.26 (4.98 to 7.86)
    6.12 (4.77 to 7.86)
        Serotype 18C: Day 0 (n=100,104,103)
    0.185 (0.156 to 0.219)
    0.220 (0.188 to 0.258)
    0.205 (0.172 to 0.244)
        Serotype 18C: Post-dose 3 (n=105,100,102)
    3.95 (3.25 to 4.80)
    3.41 (2.72 to 4.28)
    5.34 (4.37 to 6.54)
        Serotype 19F: Day 0 (n=100,104,103)
    0.308 (0.246 to 0.385)
    0.346 (0.277 to 0.433)
    0.330 (0.271 to 0.402)
        Serotype 19F: Post-dose 3 (n=105,100,102)
    3.33 (2.63 to 4.21)
    3.60 (2.86 to 4.54)
    3.83 (3.07 to 4.77)
        Serotype 23F: Day 0 (n=100,104,103)
    0.168 (0.141 to 0.201)
    0.188 (0.155 to 0.226)
    0.191 (0.158 to 0.232)
        Serotype 23F: Post-dose 3 (n=105,100,102)
    1.61 (1.36 to 1.91)
    1.47 (1.19 to 1.81)
    1.49 (1.18 to 1.89)
    No statistical analyses for this end point

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

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    End point title
    		 Primary Phase: Percentage of Subjects With >=4-fold Rise in 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 with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    28 days post third dose (i.e., Day 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    86
    91
    88
    Units: percentage of subjects
        number (confidence interval 95%)
    70.9 (60.1 to 80.2)
    67.0 (56.4 to 76.5)
    58.0 (47.0 to 68.4)
    No statistical analyses for this end point

    Secondary: Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers >= 0.35 mcg/mL

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    End point title
    		 Primary Phase: Percentage of Subjects With Anti-pneumococcal Titers >= 0.35 mcg/mL
    End point description
    Anti-Streptococcus pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies were detected by PnPS IgG ECL assay in human serum. GMCs of antibodies against antirotavirus 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 with available data 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 84)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    105
    104
    103
    Units: percentage of subjects
    number (confidence interval 95%)
        Serotype 1: Day 0 (n=100,104,103)
    4.0 (1.1 to 9.9)
    10.6 (5.4 to 18.1)
    7.8 (3.4 to 14.7)
        Serotype 1: Post-dose 3 (n=105,100,102)
    100 (96.5 to 100)
    99.0 (94.6 to 100)
    98.0 (93.1 to 99.8)
        Serotype 4: Day 0 (n=100,104,103)
    4.0 (1.1 to 9.9)
    9.6 (4.7 to 17.0)
    8.7 (4.1 to 15.9)
        Serotype 4: Post-dose 3 (n=105,100,102)
    98.1 (93.3 to 99.8)
    99.0 (94.6 to 100)
    99.0 (94.7 to 100)
        Serotype 5: Day 0 (n=100,104,103)
    2.0 (0.2 to 7.0)
    0 (0 to 3.5)
    3.9 (1.1 to 9.6)
        Serotype 5: Post-dose 3 (n=105,100,102)
    96.2 (90.5 to 99.0)
    97.0 (91.5 to 99.4)
    95.1 (88.9 to 98.4)
        Serotype 6B: Day 0 (n=100,104,103)
    13.0 (7.1 to 21.2)
    15.4 (9.1 to 23.8)
    17.5 (10.7 to 26.2)
        Serotype 6B: Post-dose 3 (n=105,100,102)
    88.6 (80.9 to 94.0)
    87.0 (78.8 to 92.9)
    85.3 (76.9 to 91.5)
        Serotype 7F: Day 0 (n=100,104,103)
    12.0 (6.4 to 20.0)
    15.4 (9.1 to 23.8)
    10.7 (5.5 to 18.3)
        Serotype 7F: Post-dose 3 (n=105,100,102)
    99.0 (94.8 to 100)
    99.0 (94.6 to 100)
    100 (96.4 to 100)
        Serotype 9V: Day 0 (n=100,104,103)
    16.0 (9.4 to 24.7)
    24.0 (16.2 to 33.4)
    13.6 (7.6 to 21.8)
        Serotype 9V: Post-dose 3 (n=105,100,102)
    100 (96.5 to 100)
    100 (96.4 to 100)
    99.0 (94.7 to 100)
        Serotype 14: Day 0 (n=100,103,103)
    80.0 (70.8 to 87.3)
    86.4 (78.2 to 92.4)
    86.4 (78.2 to 92.4)
        Serotype 14: Post-dose 3 (n=104,100,102)
    98.1 (93.2 to 99.8)
    97.0 (91.5 to 99.4)
    98.0 (93.1 to 99.8)
        Serotype 18C: Day 0 (n=100,104,103)
    21.0 (13.5 to 30.3)
    32.7 (23.8 to 42.6)
    28.2 (19.7 to 37.9)
        Serotype 18C: Post-dose 3 (n=105,100,102)
    98.1 (93.3 to 99.8)
    96.0 (90.1 to 98.9)
    99.0 (94.7 to 100)
        Serotype 19F: Day 0 (n=100,104,103)
    48.0 (37.9 to 58.2)
    48.1 (38.2 to 58.1)
    45.6 (35.8 to 55.7)
        Serotype 19F: Post-dose 3 (n=105,100,102)
    95.2 (89.2 to 98.4)
    96.0 (90.1 to 98.9)
    96.1 (90.3 to 98.9)
        Serotype 23F: Day 0 (n=100,104,103)
    24.0 (16.0 to 33.6)
    25.0 (17.0 to 34.4)
    31.1 (22.3 to 40.9)
        Serotype 23F: Post-dose 3 (n=105,100,102)
    91.4 (84.4 to 96.0)
    90.0 (82.4 to 95.1)
    82.4 (73.6 to 89.2)
    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
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    Pre-booster and 28 days after the booster dose (at Day 525-890)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [12] - Data was not collected and analysed.
    [13] - Data was not collected and analysed.
    [14] - Data was not collected and analysed.
    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
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    28 days after the booster dose (at Day 525-890)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [15] - Data was not collected and analysed.
    [16] - Data was not collected and analysed.
    [17] - Data was not collected and analysed.
    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
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    Pre-booster up to 28 days after the booster dose (at Day 525-890)
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [18] - Data was not collected and analysed.
    [19] - Data was not collected and analysed.
    [20] - Data was not collected and analysed.
    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 vaccine they actually received.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-any vaccination
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    227
    229
    231
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Primary Phase: Number of Subjects Reporting Solicited Injection Site and Systemic 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 swelling. 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 and "vacc." = vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-any and each vaccination 1, 2 and 3
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    227
    229
    231
    Units: subjects
        Tenderness: Post any vacc. (n=227,229,230)
    206
    200
    210
        Tenderness: Post vacc. 1 (n=226,229,230)
    185
    183
    187
        Tenderness: Post vacc. 2 (n=219,217,220)
    181
    161
    176
        Tenderness: Post vacc. 3 (n=215,214,217)
    164
    162
    175
        Erythema: Post any vacc. (n=227,229,230)
    106
    104
    111
        Erythema: Post vacc. 1 (n=226,228,229)
    68
    76
    73
        Erythema: Post vacc. 2 (n=219,217,220)
    70
    50
    73
        Erythema: Post vacc. 3 (n=214,214,217)
    58
    52
    68
        Swelling: Post any vacc. (n=227,229,230)
    155
    143
    143
        Swelling: Post vacc. 1 (n=226,229,229)
    122
    110
    95
        Swelling: Post vacc. 2 (n=219,217,220)
    117
    100
    105
        Swelling: Post vacc. 3 (n=214,214,217)
    103
    102
    102
        Fever: Post any vacc. (n=220,222,226)
    70
    74
    67
        Fever: Post vacc. 1 (n=218,221,223)
    34
    35
    33
        Fever: Post vacc. 2 (n=216,214,218)
    36
    30
    28
        Fever: Post vacc. 3 (n=214,212,217)
    33
    45
    28
        Vomiting: Post any vacc. (n=227,229,230)
    85
    84
    90
        Vomiting: Post vacc. 1 (n=226,229,230)
    48
    47
    58
        Vomiting: Post vacc. 2 (n=219,217,220)
    40
    36
    44
        Vomiting: Post vacc. 3 (n=214,214,217)
    38
    36
    37
        Crying abnormal: Post any vacc. (n=227,229,230)
    180
    187
    191
        Crying abnormal: Post vacc. 1 (n=226,229,230)
    149
    152
    153
        Crying abnormal: Post vacc. 2 (n=219,217,220)
    144
    142
    153
        Crying abnormal: Post vacc. 3 (n=214,214,217)
    139
    134
    144
        Drowsiness: Post any vacc. (n=227,229,230)
    132
    135
    141
        Drowsiness: Post vacc. 1 (n=226,229,230)
    88
    98
    103
        Drowsiness: Post vacc. 2 (n=219,217,220)
    91
    78
    84
        Drowsiness: Post vacc. 3 (n=214,214,217)
    86
    85
    100
        Appetite lost: Post any vacc. (n=227,229,230)
    133
    133
    141
        Appetite lost: Post vacc. 1 (n=226,229,230)
    92
    92
    91
        Appetite lost: Post vacc. 2 (n=219,217,221)
    88
    76
    89
        Appetite lost: Post vacc. 3 (n=214,214,217)
    84
    78
    87
        Irritability: Post any vacc. (n=227,229,230)
    178
    180
    190
        Irritability: Post vacc. 1 (n=226,229,230)
    151
    140
    152
        Irritability: Post vacc. 2 (n=219,217,220)
    144
    137
    148
        Irritability: Post vacc. 3 (n=214,214,217)
    132
    139
    148
    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. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Day 28 post any and each vaccination 1, 2 and 3
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    227
    229
    231
    Units: subjects
        Post any vaccination (n=227,229,231)
    146
    163
    148
        Post vaccination 1 (n=227,229,231)
    73
    86
    69
        Post vaccination 2 (n=219,217,221)
    73
    80
    71
        Post vaccination 3 (n=216,215,219)
    82
    99
    87
    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 84 post any vaccination
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    227
    229
    231
    Units: subjects
    4
    11
    11
    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
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-any vaccination
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    Units: subjects
    Notes
    [21] - Data was not collected and analysed.
    [22] - Data was not collected and analysed.
    [23] - Data was not collected and analysed.
    No statistical analyses for this end point

    Secondary: Booster Phase: Number of Subjects Reporting Solicited Injection Site and Systemic Reactions

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    End point title
    		 Booster Phase: Number of Subjects Reporting Solicited Injection Site and Systemic Reactions
    End point description
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    Within 7 days post any vaccination
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [24]
    0 [25]
    0 [26]
    Units: subjects
    Notes
    [24] - Data was not collected and analysed.
    [25] - Data was not collected and analysed.
    [26] - Data was not collected and analysed.
    No statistical analyses for this end point

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

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    End point title
    		 Booster Phase: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
    End point description
    Due to early termination of the study, Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Day 28 post any vaccination
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    Units: subjects
    Notes
    [27] - Data was not collected and analysed.
    [28] - Data was not collected and analysed.
    [29] - Data was not collected and analysed.
    No statistical analyses for this end point

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

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    End point title
    		 Booster Phase: Number of Subjects Reporting Serious Adverse Events (SAEs)
    End point description
    Due to early termination of the study Booster Phase endpoints data was not collected and analysed.
    End point type
    Secondary
    End point timeframe
    From Day 84 up to Day 890 post booster injection
    End point values
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: subjects
    Notes
    [30] - Data was not collected and analysed.
    [31] - Data was not collected and analysed.
    [32] - Data was not collected and analysed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs: Day 0 to Day 28 post any vaccination SR: within 7 post any vaccination; SAE: FromBaseline up to Day 84 post-any vaccination for primary phase of the study
    Adverse event reporting additional description
    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. SafAS. In AE section, SR fever is reported as pyrexia.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Group A: SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group B: SHAN6/SHAN 5+bOPV/SHAN6
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN6 vaccine at the age of 6 to 8 weeks, along with SHAN5 + bOPV at the age of 10 to 12 weeks and SHAN6 at the age of 14-16 weeks, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks in the primary phase of the study.

    Reporting group title
    Group C: SHAN 5 + bOPV + IPV
    Reporting group description
    		 Infants aged 6-8 weeks (at the time of enrollment) received SHAN5+bOPV vaccine, co-administered with PCV and ORV vaccines at the age of 6 to 8 weeks, 10 to 12 weeks and 14-16 weeks and IPV at 14 to 16 weeks in the primary phase of the study.

    Serious adverse events
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 227 (1.76%)
    11 / 229 (4.80%)
    11 / 231 (4.76%)
         number of deaths (all causes)
    1
    3
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Thermal Burn
         subjects affected / exposed
    0 / 227 (0.00%)
    1 / 229 (0.44%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Extensive Swelling Of Vaccinated Limb
         subjects affected / exposed
    1 / 227 (0.44%)
    0 / 229 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 227 (0.00%)
    2 / 229 (0.87%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infectious Pleural Effusion
         subjects affected / exposed
    0 / 227 (0.00%)
    1 / 229 (0.44%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 227 (0.00%)
    1 / 229 (0.44%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 227 (0.44%)
    3 / 229 (1.31%)
    5 / 231 (2.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    2 / 227 (0.88%)
    4 / 229 (1.75%)
    6 / 231 (2.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A: SHAN6 Group B: SHAN6/SHAN 5+bOPV/SHAN6 Group C: SHAN 5 + bOPV + IPV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    218 / 227 (96.04%)
    219 / 229 (95.63%)
    221 / 231 (95.67%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    132 / 227 (58.15%)
    135 / 229 (58.95%)
    141 / 231 (61.04%)
         occurrences all number
    265
    261
    287
    General disorders and administration site conditions
    Pyrexia
    Additional description: Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    74 / 227 (32.60%)
    76 / 229 (33.19%)
    68 / 231 (29.44%)
         occurrences all number
    107
    113
    90
    Injection Site Swelling
         subjects affected / exposed
    155 / 227 (68.28%)
    143 / 229 (62.45%)
    143 / 231 (61.90%)
         occurrences all number
    341
    312
    376
    Injection Site Pain
         subjects affected / exposed
    206 / 227 (90.75%)
    200 / 229 (87.34%)
    210 / 231 (90.91%)
         occurrences all number
    530
    506
    689
    Injection Site Erythema
         subjects affected / exposed
    106 / 227 (46.70%)
    104 / 229 (45.41%)
    111 / 231 (48.05%)
         occurrences all number
    195
    178
    264
    Crying
         subjects affected / exposed
    180 / 227 (79.30%)
    187 / 229 (81.66%)
    191 / 231 (82.68%)
         occurrences all number
    432
    428
    450
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    85 / 227 (37.44%)
    84 / 229 (36.68%)
    90 / 231 (38.96%)
         occurrences all number
    126
    119
    139
    Respiratory, thoracic and mediastinal disorders
    Rhinitis Allergic
         subjects affected / exposed
    15 / 227 (6.61%)
    13 / 229 (5.68%)
    13 / 231 (5.63%)
         occurrences all number
    15
    14
    13
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    178 / 227 (78.41%)
    180 / 229 (78.60%)
    190 / 231 (82.25%)
         occurrences all number
    426
    416
    449
    Infections and infestations
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    19 / 227 (8.37%)
    18 / 229 (7.86%)
    15 / 231 (6.49%)
         occurrences all number
    24
    19
    19
    Upper Respiratory Tract Infection
         subjects affected / exposed
    52 / 227 (22.91%)
    50 / 229 (21.83%)
    55 / 231 (23.81%)
         occurrences all number
    56
    60
    64
    Rhinitis
         subjects affected / exposed
    26 / 227 (11.45%)
    34 / 229 (14.85%)
    25 / 231 (10.82%)
         occurrences all number
    28
    40
    26
    Pneumonia
         subjects affected / exposed
    22 / 227 (9.69%)
    25 / 229 (10.92%)
    25 / 231 (10.82%)
         occurrences all number
    27
    32
    31
    Malaria
         subjects affected / exposed
    14 / 227 (6.17%)
    27 / 229 (11.79%)
    18 / 231 (7.79%)
         occurrences all number
    14
    30
    20
    Gastroenteritis
         subjects affected / exposed
    13 / 227 (5.73%)
    18 / 229 (7.86%)
    14 / 231 (6.06%)
         occurrences all number
    13
    20
    16
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    133 / 227 (58.59%)
    133 / 229 (58.08%)
    141 / 231 (61.04%)
         occurrences all number
    264
    246
    267

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2020
    Following changes were made: Added that the SHAN6 vaccine for this study could be used either as a single dose formulation or a multidose formulation depending on stocks available at the beginning of the study; the subset of subjects for the determination of the immune response against ORV and PCV antigens were updated. Initially half of the subjects were to be selected randomly on this purpose; The study was realised on infants and toddlers. Therefore, the blood volume taken was low and might have not been sufficient to perform both tests. In order to achieve the immunological objective initially planned, the Sponsor decided to realize the test against ORV antigen on half of the subjects, and the test against PCV on the other half of the subjects.
    20 May 2021
    Following changes were made: New study visit was added before booster administration and the booster administration was extended from 18 months to 18-30 months of age. An ICF addendum had been implemented accordingly. The closer to day care/school entry the booster dose is received, the better the boosting effect. The study design was also updated to include the possibility for subjects to receive coronavirus disease 2019 (COVID-19) vaccine, if available.

    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.
    Due to early termination of the study, booster phase endpoint data was not collected and analysed.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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