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    Clinical Trial Results:
    Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10, and 14 Weeks of Age in Infants in India Who Previously Received a Dose of Hepatitis B Vaccine at Birth

    Summary
    EudraCT number
    		 2016-002089-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2016
    First version publication date
    11 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L33
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01948193
    WHO universal trial number (UTN)
    		 U1111-1127-6936
    Other trial identifiers
    		 Clinical Trial Registry India: CTRI/2013/09/003997
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Global Medical Affairs, Sanofi Pasteur SA, 33 (0) 437 65 67 99, Emmanuel.vidor@sanofipasteur.com
    Scientific contact
    Global Medical Affairs, Sanofi Pasteur SA, 33 (0) 437 65 67 99, Emmanuel.vidor@sanofipasteur.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
    23 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of the study vaccine in terms of seroprotection (diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2, and 3, Haemophilus influenza type b [Hib] polysaccharide [PRP], hepatitis B [Hep B]) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) one month after the third dose.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were vaccinated in the study. 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 was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 All subjects enrolled in this study received a documented dose of any commercial available oral poliovirus vaccine (OPV) and recombinant Hepatitis B monovalent vaccine at birth according to the National Immunization Program (NIP) in India.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    19 Feb 2014
    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
    India: 177
    Worldwide total number of subjects
    177
    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)
    177
    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 subjects were enrolled from 19 February 2014 to 30 June 2014 at 2 clinic sites in India.

    Pre-assignment
    Screening details
    		 A total of 177 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Arm description
    		 Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine at 6, 10, and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTaP-IPV-Hep B-PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 6, 10, and 14 weeks

    Number of subjects in period 1
    		All Infants; DTaP-IPV-Hep B-PRP~T
    Started
    177
    Completed
    168
    Not completed
    9
         Serious event
    2
         Lost to follow-up
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Infants; DTaP-IPV-Hep B-PRP~T
    Reporting group description
    		 Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine at 6, 10, and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.

    Reporting group values
    		 All Infants; DTaP-IPV-Hep B-PRP~T Total
    Number of subjects
    		 177 177
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 177 177
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 6.9 ( 0.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 78 78
        Male
    		 99 99

    End points

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    End points reporting groups
    Reporting group title
    All Infants; DTaP-IPV-Hep B-PRP~T
    Reporting group description
    		 Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine at 6, 10, and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.

    Primary: Percentage of Subjects With Seroprotection After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

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    End point title
    		 Percentage of Subjects With Seroprotection After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth [1]
    End point description
    Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
    End point type
    Primary
    End point timeframe
    Pre-dose 1 to one month post-dose 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study group and study vaccine administered for this outcome.
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    156
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Post-dose 3, ≥ 0.01
    99.3
        Anti-Tetanus; Post-dose 3, ≥ 0.01
    100
        Anti-Polio 1; Post-dose 3
    100
        Anti-Polio 2; Post-dose 3
    100
        Anti-Polio 3; Post-dose 3
    100
        Anti-Hep B; Post-dose 3, ≥ 10
    100
        Anti-PRP; Post-dose 3, ≥ 0.15
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Vaccine Response After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

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    End point title
    		 Percentage of Subjects With Vaccine Response After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth [2]
    End point description
    Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.
    End point type
    Primary
    End point timeframe
    Pre-dose 1 to one month post-dose 3
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study group and study vaccine administered for this outcome.
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    156
    Units: Percentage of subjects
    number (not applicable)
        Anti-PT; Pre-dose 1
    59.9
        Anti-PT; Vaccine response
    93.8
        Anti-PT; ≥4-fold increase
    88.4
        Anti-FHA; Pre-dose 1
    88.7
        Anti-FHA; Vaccine response
    99.3
        Anti-FHA; ≥4-fold increase
    90.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection Before and After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

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    End point title
    		 Percentage of Subjects With Seroprotection Before and After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
    End point description
    Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 to one month post-dose 3
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    156
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Pre-dose 1; ≥0.01
    67.1
        Anti-Diphtheria; Pre-dose 1; ≥0.1
    15.8
        Anti-Diphtheria; Post-dose 3; ≥0.01
    99.3
        Anti-Diphtheria; Post-dose 3; ≥0.1
    49.6
        Anti-Diphtheria; Post-dose 3; ≥1.0
    5.2
        Anti-Tetanus; Post-dose 3; ≥0.01
    100
        Anti-Tetanus; Post-dose 3; ≥0.1
    100
        Anti-Tetanus; Post-dose 3; ≥1.0
    84.3
        Anti-Polio 1; Post-dose 3
    100
        Anti-Polio 2; Post-dose 3
    100
        Anti-Polio 3; Post-dose 3
    100
        Anti-Hep B; Pre-dose 1, ≥10
    13.2
        Anti-Hep B; Post-dose 3, ≥10
    100
        Anti-Hep B; Post-dose 3, ≥100
    99.3
        Anti-PRP; Post-dose 3, ≥0.15
    100
        Anti-PRP; Post-dose 3, ≥1.0
    93.6
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
    End point description
    Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 to one month post-dose 3
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    156
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-dose 1
    0.019 (0.015 to 0.025)
        Anti-Diphtheria; Post-dose 3
    0.12 (0.099 to 0.146)
        Anti-Tetanus; Post-dose 3
    1.95 (1.75 to 2.17)
        Anti-PT; Pre-dose 1
    3.84 (3 to 4.91)
        Anti-PT; Post-dose 3
    191 (173 to 210)
        Anti-FHA; Pre-dose 1
    6.17 (5.1 to 7.48)
        Anti-FHA; Post-dose 3
    226 (208 to 247)
        Anti-Polio 1; Post-dose 3
    1124 (861 to 1468)
        Anti-Polio 2; Post-dose 3
    1401 (1108 to 1771)
        Anti-Polio 3; Post-dose 3
    2019 (1672 to 2437)
        Anti-Hep B; Pre-dose 1
    3.78 (3.23 to 4.43)
        Anti-Hep B; Post-dose 3
    2491 (2073 to 2995)
        Anti-PRP; Post-dose 3
    7.86 (6.35 to 9.73)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth
    End point description
    Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 to one month post-dose 3
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    156
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    5.85 (3.93 to 8.72)
        Anti-PT
    50.7 (37.3 to 69)
        Anti-FHA
    36.6 (28.6 to 46.8)
        Anti-Hep B
    686 (542 to 870)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth
    End point description
    Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each vaccine injection
    End point values
    		 All Infants; DTaP-IPV-Hep B-PRP~T
    Number of subjects analysed
    177
    Units: Percentage of subjects
    number (not applicable)
        Any Injection-site Tenderness; Post Inj. 1
    19
        Grade 3 Inj. site Tenderness; Post Inj 1
    2.3
        Any Injection-site Erythema; Post Inj. 1
    4.6
        Grade 3 Inj. site Erythema; Post Inj. 1
    0
        Any Injection-site Swelling; Post Inj. 1
    10.3
        Grade 3 Inj. site Swelling; Post Inj. 1
    0
        Any Injection-site Tenderness; Post Inj. 2
    13.8
        Grade 3 Inj.-site Tenderness; Post Inj. 2
    1.1
        Any Injection-site Erythema; Post Inj. 2
    3.4
        Grade 3 Inj. site Erythema; Post Inj. 2
    0
        Any Injection-site Swelling; Post Inj. 2
    3.4
        Grade 3 Inj. site Swelling; Post Inj. 2
    0
        Any Injection-site Tenderness; Post Inj. 3
    11.9
        Grade 3 Inj. site Tenderness; Post Inj. 3
    0
        Any Injection-site Erythema; Post Inj. 3
    0.6
        Grade 3 Inj. site Erythema; Post Inj. 3
    0
        Any Injection-site Swelling; Post Inj. 3
    6.5
        Grade 3 Inj. site Swelling; Post Inj. 3
    0
        Any Fever; Post-injection 1
    7.5
        Grade 3 Fever; Post-injection 1
    0
        Any Vomiting; Post-injection 1
    9.8
        Grade 3 Vomiting; Post-injection 1
    0
        Any Crying abnormal; Post-injection 1
    16.1
        Grade 3 Crying abnormal; Post-injection 1
    1.1
        Any Drowsiness; Post injection 1
    9.8
        Grade 3 Drowsiness; Post Inj. 1
    1.1
        Any Appetite lost; Post Inj. 1
    6.9
        Grade 3 Appetite lost; Post Inj. 1
    0
        Any Irritability; Post Inj. 1
    22.4
        Grade 3 Irritability; Post Inj. 1
    0.6
        Any Fever; Post Inj. 2
    8.6
        Grade 3 Fever; Post Inj. 2
    0
        Any Vomiting; Post Inj. 2
    3.4
        Grade 3 Vomiting; Post Inj. 2
    0
        Any Crying abnormal; Post Inj. 2
    9.8
        Grade 3 Crying abnormal; Post Inj. 2
    0
        Any Drowsiness; Post Inj. 2
    3.4
        Grade 3 Drowsiness; Post Inj. 2
    0
        Any Appetite lost; Post Inj. 2
    3.4
        Grade 3 Appetite lost; Post Inj. 2
    0
        Any Irritability; Post Inj. 2
    16.7
        Grade 3 Irritability; Post Inj. 2
    0
        Any Fever; Post Inj. 3
    7.1
        Grade 3 Fever; Post Inj. 3
    0
        Any Vomiting; Post Inj. 3
    3
        Grade 3 Vomiting; Post Inj. 3
    0
        Any Crying abnormal; Post Inj. 3
    7.7
        Grade 3 Crying abnormal; Post Inj. 3
    0
        Any Drowsiness; Post Inj. 3
    3
        Grade 3 Drowsiness; Post Inj. 3
    0
        Any Appetite lost; Post Inj. 3
    3
        Grade 3 Appetite lost; Post Inj. 3
    0
        Any Irritability; Post Inj. 3
    12.5
        Grade 3 Irritability; Post Inj. 3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected following first vaccination up to Day 30 post-dose 3.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    All Infants; DTaP IPV HB PRP~T
    Reporting group description
    		 Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur's DTaP IPV HB PRP~T combined vaccine at 6, 10, and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.

    Serious adverse events
    		 All Infants; DTaP IPV HB PRP~T
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 177 (1.69%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Infants; DTaP IPV HB PRP~T
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 177 (22.03%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    17 / 174 (9.77%)
         occurrences all number
    17
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    33 / 174 (18.97%)
         occurrences all number
    33
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    8 / 174 (4.60%)
         occurrences all number
    8
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    18 / 174 (10.34%)
         occurrences all number
    18
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    15 / 174 (8.62%)
         occurrences all number
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 177 (5.08%)
         occurrences all number
    9
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    17 / 174 (9.77%)
         occurrences all number
    17
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    28 / 174 (16.09%)
         occurrences all number
    28
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    39 / 174 (22.41%)
         occurrences all number
    39
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    21 / 177 (11.86%)
         occurrences all number
    24
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    12 / 174 (6.90%)
         occurrences all number
    12
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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