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    Clinical Trial Results:
    Immune Responses in Adults to Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose

    Summary
    EudraCT number
    		 2015-005842-69
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Sep 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2016
    First version publication date
    13 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Td526
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00712959
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Director, Clinical Development, Sanofi Pasteur Inc., 570 957-3570, emilia.jordanov@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur Inc., 570 957-3570, emilia.jordanov@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To compare the diphtheria and tetanus seroprotection rates in Group 1 and Group 2 approximately one month post Tdap-vaccination 2) To compare the pertussis antibody geometric mean concentrations (GMCs) in Group 1 and Group 2 approximately one month post Tdap-vaccination
    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
    		 Subjects from studies Td9707 and Td9805 who previously received Tdap or Tdap-vIPV vaccines were enrolled in study Td526. In Td526, subjects from the Td9707 and Td9805 studies either qualified for Tdap revaccination (Group 1) or were age-balanced vaccine-naive subjects who received Tdap vaccine at least 10 years after a previous tetanus, diphtheria and/or pertussis dose (Group 2).
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    26 Jun 2008
    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
    Canada: 768
    Worldwide total number of subjects
    768
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    758
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.

    Pre-assignment
    Screening details
    		 A total of 769 subjects who met all the inclusion and none of the exclusion criteria were enrolled, 768 subjects were vaccinated and evaluated.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Previous Tdap or Tdap-IPV Recipients
    Arm description
    		 Subjects received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (Td9707 or Td9805).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 dose of Tdap vaccine on Day 0.

    Arm title
    		 Group 2: Tdap Vaccine-naive
    Arm description
    		 Age-balanced Tdap vaccine-naive subjects who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 dose of Tdap vaccine on Day 0.

    Number of subjects in period 1
    		Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Started
    361
    407
    Completed
    342
    404
    Not completed
    19
    3
         Consent withdrawn by subject
    3
    -
         Lost to follow-up
    13
    2
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Previous Tdap or Tdap-IPV Recipients
    Reporting group description
    		 Subjects received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (Td9707 or Td9805).

    Reporting group title
    Group 2: Tdap Vaccine-naive
    Reporting group description
    		 Age-balanced Tdap vaccine-naive subjects who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.

    Reporting group values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive Total
    Number of subjects
    		 361 407 768
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 356 402 758
        From 65-84 years
    		 5 5 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.2 ( 14 ) 34.6 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 194 264 458
        Male
    		 167 143 310

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Previous Tdap or Tdap-IPV Recipients
    Reporting group description
    		 Subjects received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (Td9707 or Td9805).

    Reporting group title
    Group 2: Tdap Vaccine-naive
    Reporting group description
    		 Age-balanced Tdap vaccine-naive subjects who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.

    Primary: Percentage of Subjects With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Percentage of Subjects With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose [1]
    End point description
    Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 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
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Percentage of subjects
    number (not applicable)
        Anti-Tetanus Pre-vaccination
    45
    49
        Anti-Tetanus Post-vaccination
    100
    100
        Anti-Diphtheria Pre-vaccination
    74
    66
        Anti-Diphtheria Post-vaccination
    99
    96
    No statistical analyses for this end point

    Primary: Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose [2]
    End point description
    Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM) were determined by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    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 groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis Toxoid
    116 (105 to 129)
    89.2 (80.2 to 99.3)
        Filamentous hemagglutinin
    214 (199 to 231)
    249 (229 to 272)
        Pertactin
    266 (243 to 292)
    216 (188 to 247)
        Fimbriae Types 2 and 3
    779 (720 to 843)
    1015 (894 to 1154)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Achieving Booster Response of Anti-Tetanus and Anti-Diphtheria Following Revaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Percentage of Subjects Achieving Booster Response of Anti-Tetanus and Anti-Diphtheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
    End point description
    Anti-Diphtheria or anti-Tetanus booster responses were defined as: Pre-vaccination antibody concentrations of < 0.1 IU/mL and post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.
    End point type
    Other pre-specified
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Percentage of subjects
    number (not applicable)
        Anti-Tetanus
    83
    82
        Anti-Diphtheria
    86
    81
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Percentage of Subjects Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
    End point description
    Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration: ≥ 4 x the lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.
    End point type
    Other pre-specified
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Percentage of subjects
    number (not applicable)
        Anti-Pertussis Toxoid
    88
    84
        Filamentous hemagglutinin
    88
    94
        Pertactin
    90
    93
        Fimbriae Types 2 and 3
    84
    93
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
    End point description
    Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM) were determined by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis Toxoid Pre-vaccination
    15.1 (12.9 to 17.6)
    9.42 (8.2 to 10.8)
        Pertussis Toxoid Post-vaccination
    116 (105 to 129)
    89.2 (80.2 to 99.3)
        Filamentous hemagglutinin Pre-vaccination
    34.8 (31.2 to 38.7)
    20 (17.7 to 22.5)
        Filamentous hemagglutinin Post-vaccination
    214 (199 to 231)
    249 (229 to 272)
        Pertactin Pre-vaccination
    28.2 (24.4 to 32.7)
    8.54 (7.41 to 9.85)
        Pertactin Post-vaccination
    266 (243 to 292)
    216 (188 to 247)
        Fimbriae Types 2 and 3 Pre-vaccination
    124 (111 to 139)
    37.8 (32.7 to 43.7)
        Fimbriae Types 2 and 3 Post-vaccination
    779 (720 to 843)
    1015 (894 to 1154)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
    End point description
    Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for Tetanus was determined by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    324
    381
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Tetanus Pre-vaccination
    0.835 (0.754 to 0.924)
    0.778 (0.679 to 0.892)
        Anti-Tetanus Post-vaccination
    8.79 (8.06 to 9.59)
    9.64 (8.73 to 10.7)
        Anti-Diphtheria Pre-vaccination
    0.283 (0.235 to 0.341)
    0.198 (0.163 to 0.24)
        Anti-Diphtheria Post-vaccination
    4.06 (3.49 to 4.71)
    2.74 (2.36 to 3.18)
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose

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    End point title
    		 Number of Subjects Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
    End point description
    Solicited Injection site reactions: Pain, Erythema, and Swelling. Solicited Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling, ≥ 5 cm. Grade 3 Systemic reactions: Fever, > 39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Number of subjects analysed
    361
    407
    Units: Number of subjects
    number (not applicable)
        Any Pain
    309
    341
        Grade 3 Pain
    9
    7
        Any Erythema
    81
    120
        Grade 3 Erythema
    7
    7
        Any Swelling
    72
    94
        Grade 3 Swelling
    9
    7
        Any Fever
    15
    20
        Grade 3 Fever
    0
    0
        Any Headache
    142
    152
        Grade 3 Headache
    6
    8
        Any Malaise
    103
    117
        Grade 3 Malaise
    7
    8
        Any Myalgia
    211
    216
        Grade 3 Myalgia
    8
    6
    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 collection from Day 0 (post-vaccination) up to 6 months post-vaccination.
    Adverse event reporting additional description
    The diary cards for solicited safety data were not returned for some subjects; the total number for each event therefore represents those with available data for the indicated event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Group 1: Previous Tdap or Tdap-IPV Recipients
    Reporting group description
    		 Subjects received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (Td9707 or Td9805).

    Reporting group title
    Group 2: Tdap Vaccine-naive
    Reporting group description
    		 Age-balanced Tdap vaccine-naive subjects who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.

    Serious adverse events
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 361 (0.83%)
    1 / 407 (0.25%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 361 (0.28%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation
         subjects affected / exposed
    1 / 361 (0.28%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 361 (0.00%)
    1 / 407 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Vaginal haematoma
         subjects affected / exposed
    1 / 361 (0.28%)
    0 / 407 (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
    		 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    309 / 361 (85.60%)
    341 / 407 (83.78%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    142 / 350 (40.57%)
    152 / 404 (37.62%)
         occurrences all number
    142
    152
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    309 / 352 (87.78%)
    341 / 404 (84.41%)
         occurrences all number
    309
    341
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    81 / 351 (23.08%)
    120 / 404 (29.70%)
         occurrences all number
    81
    120
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    103 / 350 (29.43%)
    117 / 404 (28.96%)
         occurrences all number
    103
    117
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    72 / 351 (20.51%)
    94 / 403 (23.33%)
         occurrences all number
    72
    94
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    14 / 361 (3.88%)
    22 / 407 (5.41%)
         occurrences all number
    14
    23
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    211 / 351 (60.11%)
    216 / 404 (53.47%)
         occurrences all number
    211
    216
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    30 / 361 (8.31%)
    23 / 407 (5.65%)
         occurrences all number
    31
    23
    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 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 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 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 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 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 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? Yes
    Date
    Amendment
    03 Jun 2008
    Provided explanation that the use of contraception was not required after Day 28 post-vaccination; non-standard study procedures, information on the handling of missing data, and non-standard lost to follow-up procedures were deleted; reporting of the vaccine batch number was clarified; and instructions for diary card as well as the calendar dates were updated.

    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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