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    Clinical Trial Results:
    Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute of Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China

    Summary
    EudraCT number
    		 2015-005189-48
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2016
    First version publication date
    18 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MPS01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01430611
    WHO universal trial number (UTN)
    		 U1111-1120-1190
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 66 96 18, philipp.oster@sanofipasteur.com
    Scientific contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 66 96 18, philipp.oster@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
    31 Aug 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and 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
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    23 Aug 2011
    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
    China: 665
    Worldwide total number of subjects
    665
    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)
    0
    Children (2-11 years)
    665
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study subjects were enrolled from 23 August 2011 to 12 October 2011 at a single center in China.

    Pre-assignment
    Screening details
    		 A total of 665 of the 666 subjects who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The trial was designed as a blind observer study. The vaccinator who administered the injections could not be blinded since the control vaccine differed front the investigational product. The staff members who collected safety data, Investigator, subjects, subjects' parents, laboratory personnel who analyzed the blood samples, and the Sponsor were all blinded to group assignment. If an emergency occurred, the Investigator could break the code using the decoding list as described in the protocol.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Meningo A+C® (Group 1)
    Arm description
    		 Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (Groups A and C) Polysaccharide Vaccine, manufactured by Sanofi Pasteur
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous in the anterolateral aspect of the upper arm, 1 injection on Day 0.

    Arm title
    		 Meng Ling Kang® (Group 2)
    Arm description
    		 Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal (Groups A and C) Polysaccharide Vaccine, manufactured by Lanzhou Institute of Biologicals
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous in the anterolateral aspect of the upper arm, 1 injection on Day 0.

    Number of subjects in period 1
    		Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Started
    332
    333
    Completed
    315
    318
    Not completed
    17
    15
         Consent withdrawn by subject
    15
    14
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Meningo A+C® (Group 1)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine.

    Reporting group title
    Meng Ling Kang® (Group 2)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine.

    Reporting group values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2) Total
    Number of subjects
    		 332 333 665
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 332 333 665
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.2 ± 1.1 3.1 ± 1 -
    Gender categorical
    Units: Subjects
        Female
    		 144 133 277
        Male
    		 188 200 388

    End points

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    End points reporting groups
    Reporting group title
    Meningo A+C® (Group 1)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine.

    Reporting group title
    Meng Ling Kang® (Group 2)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine.

    Primary: Number of Subjects With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Number of Subjects With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine [1]
    End point description
    Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    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 groups and the study vaccine administered for this outcome.
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    304
    308
    Units: Number of subjects
    number (not applicable)
        Serogroup A
    295
    301
        Serogroup C
    288
    292
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Post-vaccination Titer ≥ 1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Percentage of Subjects with Post-vaccination Titer ≥ 1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    304
    308
    Units: Percentage of subjects
    number (not applicable)
        Serogroup A (pre-vaccination)
    12.5
    8.8
        Serogroup A (post-vaccination)
    98
    99
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Post-vaccination Titer ≥ 1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Percentage of Subjects With Post-vaccination Titer ≥ 1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    304
    308
    Units: Percentage of subjects
    number (not applicable)
        Serogroup C (pre-vaccination)
    25
    26
        Serogroup C (post-vaccination)
    97
    96.8
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    332
    333
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serogroup A (pre-vaccination)
    1.75 (1.52 to 2)
    1.45 (1.29 to 1.63)
        Serogroup A (post-vaccination)
    207 (182 to 236)
    223 (201 to 248)
        Serogroup C (pre-vaccination)
    3.57 (3.2 to 3.97)
    3.65 (3.28 to 4.07)
        Serogroup C (post-vaccination)
    181 (158 to 208)
    192 (168 to 220)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    304
    308
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serogroup A (pre-vaccination)
    1.71 (1.49 to 1.97)
    1.44 (1.27 to 1.63)
        Serogroup A (post-vaccination)
    203 (178 to 233)
    225 (202 to 250)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    304
    308
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serogroup C (pre-vaccination)
    3.66 (3.27 to 4.1)
    3.64 (3.25 to 4.07)
        Serogroup C (post-vaccination)
    179 (155 to 206)
    191 (167 to 220)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

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    End point title
    		 Number of Subjects Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
    End point description
    Solicited Injection site: Pain, Erythema, and Swelling. Solicited Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 Systemic reactions: Fever, temperature >39°C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Number of subjects analysed
    331
    332
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    82
    71
        Grade 3 Injection site Pain
    1
    0
        Injection site Erythema
    44
    32
        Grade 3 Injection site Erythema
    1
    0
        Injection site Swelling
    20
    17
        Grade 3 Injection site Swelling
    0
    1
        Fever
    46
    39
        Grade 3 Fever
    1
    0
        Headache
    27
    20
        Grade 3 Headache
    0
    0
        Malaise
    32
    33
        Grade 3 Malaise
    0
    0
        Myalgia
    29
    42
        Grade 3 Myalgia
    0
    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 from Day 0 (post-vaccination) up to Day 30 post-vaccination.
    Adverse event reporting additional description
    A Group 2 subject received the wrong vaccine and was included in the Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Meningo A+C® (Group 1)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine.

    Reporting group title
    Meng Ling Kang® (Group 2)
    Reporting group description
    		 Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine.

    Serious adverse events
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 333 (0.60%)
    1 / 332 (0.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 332 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 332 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 333 (24.62%)
    71 / 332 (21.39%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    27 / 331 (8.16%)
    20 / 331 (6.04%)
         occurrences all number
    27
    20
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    82 / 331 (24.77%)
    71 / 331 (21.45%)
         occurrences all number
    82
    71
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    44 / 331 (13.29%)
    32 / 331 (9.67%)
         occurrences all number
    44
    32
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    20 / 331 (6.04%)
    17 / 331 (5.14%)
         occurrences all number
    20
    17
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    46 / 330 (13.94%)
    39 / 330 (11.82%)
         occurrences all number
    46
    39
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    32 / 331 (9.67%)
    33 / 331 (9.97%)
         occurrences all number
    32
    33
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    17 / 333 (5.11%)
    29 / 332 (8.73%)
         occurrences all number
    17
    32
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    29 / 331 (8.76%)
    42 / 331 (12.69%)
         occurrences all number
    29
    42
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    56 / 333 (16.82%)
    46 / 332 (13.86%)
         occurrences all number
    60
    48
    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 after 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 after 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 after 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 after 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 after 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 after 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 after 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.

    More information

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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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