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    Clinical Trial Results:
    Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults

    Summary
    EudraCT number
    		 2009-009877-85
    Trial protocol
    		 FR  
    Global end of trial date
    14 Feb 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    04 Feb 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VRV01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00948272
    WHO universal trial number (UTN)
    		 U1111-1111-4382
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, Avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 5851, sylvie.pichon@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 5851, sylvie.pichon@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
    20 Apr 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that VRVg (PR1) is at least as immunogenic as the reference vaccine, Verorab (PR2), in terms of seroconversion rate at Day 42, i.e. 14 days after the last vaccination of primary vaccination series.
    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 kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Verorab, licensed since 1985 and also marketed as Vaccin Rabique Pasteur in France, was used as a reference vaccine.
    Actual start date of recruitment
    20 Jul 2009
    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
    France: 385
    Worldwide total number of subjects
    385
    EEA total number of subjects
    385
    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)
    385
    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 20 July 2009 to 27 July 2009 in 6 clinical centers in France.

    Pre-assignment
    Screening details
    		 A total of 385 subjects who met all inclusion criteria and none of the exclusion criteria were randomized, 384 subjects were vaccinated.

    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
    Blinding implementation details
    Neither the Investigator, the subjects, nor the Sponsor knew the vaccine administered. The product preparation and administration, and the assessment of safety were performed by 2 different individuals in separate rooms. The Investigator or delegate included subjects and evaluated the immediate safety post- vaccination. The nurse/vaccinator prepared and administered the vaccine in a separate room and had sole access to the product accountability forms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VRVg
    Arm description
    		 Subjects aged 18 to 60 years who received three injections of Purified Vero Rabies Vaccine - Serum Free (VRVg) for primary series on Day 0, 7, and 28 and a VRVg booster 12 months after the first vaccine injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Purified Vero Rabies Vaccine - Serum Free (VRVg)
    Investigational medicinal product code
    382
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular, 3 injections on Day 0, 7, and 28 (primary series) and a booster 12 months after the first vaccine injection.

    Arm title
    		 Verorab
    Arm description
    		 Subjects aged 18 to 60 years who received three injections of Verorab for primary series on Day 0, 7, and 28 and randomized to receive either Verorab or VRVg booster 12 months after the first vaccine injection.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Verorab
    Investigational medicinal product code
    084
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular, 3 injections on Day 0, 7, and 28 (primary series) and a booster with either vaccine at 12 months after the first vaccine injection.

    Investigational medicinal product name
    Purified Vero Rabies Vaccine - Serum Free (VRVg)
    Investigational medicinal product code
    382
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular, 3 injections on Day 0, 7, and 28 (primary series) and a booster with either vaccine at 12 months after the first vaccine injection.

    Number of subjects in period 1
    		VRVg Verorab
    Started
    257
    128
    Completed
    250
    126
    Not completed
    7
    2
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VRVg
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Purified Vero Rabies Vaccine - Serum Free (VRVg) for primary series on Day 0, 7, and 28 and a VRVg booster 12 months after the first vaccine injection.

    Reporting group title
    Verorab
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Verorab for primary series on Day 0, 7, and 28 and randomized to receive either Verorab or VRVg booster 12 months after the first vaccine injection.

    Reporting group values
    		 VRVg Verorab Total
    Number of subjects
    		 257 128 385
    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)
    		 257 128 385
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39 ( 13.3 ) 39 ( 13.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 156 74 230
        Male
    		 101 54 155

    End points

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    End points reporting groups
    Reporting group title
    VRVg
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Purified Vero Rabies Vaccine - Serum Free (VRVg) for primary series on Day 0, 7, and 28 and a VRVg booster 12 months after the first vaccine injection.

    Reporting group title
    Verorab
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Verorab for primary series on Day 0, 7, and 28 and randomized to receive either Verorab or VRVg booster 12 months after the first vaccine injection.

    Primary: Percentage of Healthy Adult Subjects Achieving Seroconversion After Primary Series Vaccination with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine in Pre-Exposure Use

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    End point title
    		 Percentage of Healthy Adult Subjects Achieving Seroconversion After Primary Series Vaccination with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine in Pre-Exposure Use
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). Seroconversion was defined as subject with a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL on Day 42.
    End point type
    Primary
    End point timeframe
    Day 42 post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    228
    118
    Units: Percentage of subjects
    number (not applicable)
        Subjects with RVNA titer ≥0.5 IU/mL
    99.6
    100
    Statistical analysis title
    		 Non-inferiority of VRVg versus Verorab
    Comparison groups
    VRVg v Verorab
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.7
    Notes
    [1] - Non-inferiority concluded if the low limit of the two-sided 95% CI of the difference VRVg - Verorab for proportion of subjects with RVNA titer ≥0.5 IU/mL is > -5.0%.

    Secondary: Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Each Primary Series Vaccination with Either Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adult Subjects

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    End point title
    		 Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Each Primary Series Vaccination with Either Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adult Subjects
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 42, Month 6, and Month 12 post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    256
    128
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    0.113 (0.104 to 0.122)
    0.105 (0.099 to 0.111)
        Day 42
    13.5 (12.1 to 15)
    14.8 (13 to 16.9)
        Month 6
    1.08 (0.954 to 1.23)
    1.52 (1.28 to 1.8)
        Month 12
    0.666 (0.58 to 0.765)
    0.968 (0.797 to 1.17)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Seroconversion Before and After Primary Series Vaccination with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine in Pre-exposure Use

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    End point title
    		 Percentage of Subjects Achieving Seroconversion Before and After Primary Series Vaccination with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine in Pre-exposure Use
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). Seroconversion was defined as subject with a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 42, Month 6, and Month 12 post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    256
    128
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    2.7
    1.6
        Day 42
    99.6
    100
        Month 6
    89.1
    93.5
        Month 12
    77.5
    80.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Seroconversion After Primary Series with Either Purified Vero Rabies Vaccine–Serum Free (VRVg) or Reference Purified Vero Rabies Vaccine and Booster with VRVg

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    End point title
    		 Percentage of Subjects Achieving Seroconversion After Primary Series with Either Purified Vero Rabies Vaccine–Serum Free (VRVg) or Reference Purified Vero Rabies Vaccine and Booster with VRVg
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). Seroconversion was defined as subject with a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL.
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 12 + 14 days post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    230
    57
    Units: Percentage of subjects
    number (not applicable)
        Month 12
    77.4
    77.2
        Month 12 + 14 days
    99.6
    100
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Adult Subjects achieving Seroconversion Following Primary Series and Booster with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine

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    End point title
    		 Percentage of Healthy Adult Subjects achieving Seroconversion Following Primary Series and Booster with Either Purified Vero Rabies Vaccine–Serum Free or Reference Purified Vero Rabies Vaccine
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). Seroconversion was defined as subject with a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL.
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 12 + 14 days post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    230
    60
    Units: Percentage of subjects
    number (not applicable)
        Month 12
    77.4
    83.3
        Month 12 + 14 days
    99.6
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) After Primary Series with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or Reference Purified Vero Rabies Vaccine and Booster with VRVg in Healthy Adult Subjects

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    End point title
    		 Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) After Primary Series with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or Reference Purified Vero Rabies Vaccine and Booster with VRVg in Healthy Adult Subjects
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). The booster vaccine for this outcome is the Purified Vero Rabies Vaccine – Serum Free (VRVg)
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 12 + 14 days post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    230
    57
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Month 12
    0.667 (0.58 to 0.766)
    0.912 (0.678 to 1.23)
        Month 12 + 14 days
    27.1 (23.3 to 31.4)
    28.4 (21.1 to 38.2)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Primary Series Vaccination and Booster Vaccination with Either Purified Vero Rabies Vaccine – Serum Free or the Reference Purified Vero Rabies Vaccine

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    End point title
    		 Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Primary Series Vaccination and Booster Vaccination with Either Purified Vero Rabies Vaccine – Serum Free or the Reference Purified Vero Rabies Vaccine
    End point description
    Rabies virus neutralizing antibody titers were assessed using rapid fluorescent focus inhibition test (RFFIT). The booster vaccine was the same as same primary vaccine for this outcome.
    End point type
    Secondary
    End point timeframe
    Month 12 and Month 12 + 14 days post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    230
    60
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Month 12
    0.667 (0.58 to 0.766)
    1.03 (0.792 to 1.34)
        Month 12 + 14 days
    27.1 (23.3 to 31.4)
    22.5 (17.9 to 28.4)
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Adult Subjects Reporting Solicited Injection-site or Systemic Reactions Following Primary Series Vaccination with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or the Reference Purified Vero Rabies Vaccine

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    End point title
    		 Percentage of Healthy Adult Subjects Reporting Solicited Injection-site or Systemic Reactions Following Primary Series Vaccination with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or the Reference Purified Vero Rabies Vaccine
    End point description
    Solicited injection site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Severe injection site: Pain – Significant; prevents daily activity; Erythema and Swelling – >10 cm. Severe systemic reactions: Fever – ≥39.0°C; Headache, Malaise, and Myalgia – Significant; prevents daily activities.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 VRVg Verorab
    Number of subjects analysed
    256
    128
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain; Post-Any Injection
    25
    34.4
        Grade 3 Injection site Pain; Post-Any Injection
    0
    0
        Injection site Erythema; Post-Any Injection
    0.8
    3.9
        Grade 3 Injection site Erythema;Post-Any Injection
    0
    0
        Injection site Swelling; Post-Any Injection
    1.2
    4.7
        Grade 3 Injection site Swelling;Post-Any Injection
    0
    0
        Injection site Pain; Post-Injection 1
    11.4
    18.8
        Grade 3 Injection site Pain; Post-Injection 1
    0
    0
        Injection site Erythema; Post-Injection 1
    0.4
    1.6
        Grade 3 Injection site Erythema; Post-Injection 1
    0
    0
        Injection site Swelling; Post-Injection 1
    1.2
    1.6
        Grade 3 Injection site Swelling; Post-Injection 1
    0
    0
        Injection site Pain; Post-Injection 2
    10.3
    17.3
        Grade 3 Injection site Pain; Post-Injection 2
    0
    0
        Injection site Erythema; Post-Injection 2
    0
    1.6
        Grade 3 Injection site Erythema; Post-Injection 2
    0
    0
        Injection site Swelling; Post-Injection 2
    0.4
    0.8
        Grade 3 Injection site Swelling; Post-Injection 2
    0
    0
        Injection site Pain; Post-Injection 3
    14.8
    16.5
        Grade 3 Injection site Pain; Post-Injection 3
    0
    0
        Injection site Erythema; Post-Injection 3
    0.8
    2.4
        Grade 3 Injection site Erythema; Post-Injection 3
    0
    0
        Injection site Swelling; Post-Injection 3
    0.8
    2.4
        Grade 3 Injection site Swelling; Post-Injection 3
    0
    0
        Fever; Post-Any Injection
    0.8
    3.9
        Grade 3 Fever; Post-Any Injection
    0
    0.8
        Headache; Post-Any Injection
    34.4
    34.4
        Grade 3 Headache; Post-Any Injection
    1.2
    1.6
        Malaise; Post-Any Injection
    9
    16.4
        Grade 3 Malaise; Post-Any Injection
    0.4
    0.8
        Myalgia; Post-Any Injection
    29.7
    25
        Grade 3 Myalgia; Post-Any Injection
    1.2
    0.8
        Fever; Post-Injection 1
    0.8
    2.3
        Grade 3 Fever; Post-Injection 1
    0
    0.8
        Headache; Post-Injection 1
    23.9
    21.9
        Grade 3 Headache; Post-Injection 1
    0
    0.8
        Malaise; Post-Injection 1
    6.7
    12.5
        Grade 3 Malaise; Post-Injection 1
    0.4
    0
        Myalgia; Post-Injection 1
    19.2
    15.6
        Grade 3 Myalgia; Post-Injection 1
    0.4
    0
        Fever; Post-Injection 2
    0
    0.8
        Grade 3 Fever; Post-Injection 2
    0
    0
        Headache; Post-Injection 2
    17
    15.7
        Grade 3 Headache; Post-Injection 2
    0.4
    0.8
        Malaise; Post-Injection 2
    2.4
    3.9
        Grade 3 Malaise; Post-Injection 2
    0
    0.8
        Myalgia; Post-Injection 2
    11.5
    10.2
        Grade 3 Myalgia; Post-Injection 2
    0.4
    0.8
        Fever; Post-Injection 3
    0
    0.8
        Grade 3 Fever; Post-Injection 3
    0
    0
        Headache; Post-Injection 3
    11.2
    11.8
        Grade 3 Headache; Post-Injection 3
    0.8
    0
        Malaise; Post-Injection 3
    0.8
    2.4
        Grade 3 Malaise; Post-Injection 3
    0
    0
        Myalgia; Post-Injection 3
    9.6
    7.1
        Grade 3 Myalgia; Post-Injection 3
    0.4
    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 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    VRVg
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Purified Vero Rabies Vaccine - Serum Free (VRVg) for primary series on Day 0, 7, and 28 and a VRVg booster 12 months after the first vaccine injection.

    Reporting group title
    Verorab
    Reporting group description
    		 Subjects aged 18 to 60 years who received three injections of Verorab for primary series on Day 0, 7, and 28 and randomized to receive either Verorab or VRVg booster 12 months after the first vaccine injection.

    Serious adverse events
    		 VRVg Verorab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 256 (0.39%)
    1 / 128 (0.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 256 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 256 (0.39%)
    0 / 128 (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
    		 VRVg Verorab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 256 (34.38%)
    44 / 128 (34.38%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    88 / 256 (34.38%)
    44 / 128 (34.38%)
         occurrences all number
    132
    63
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    64 / 256 (25.00%)
    44 / 128 (34.38%)
         occurrences all number
    92
    67
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 256 (8.98%)
    21 / 128 (16.41%)
         occurrences all number
    25
    24
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 256 (5.47%)
    5 / 128 (3.91%)
         occurrences all number
    15
    6
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 256 (29.69%)
    32 / 128 (25.00%)
         occurrences all number
    102
    42

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2009
    Clarification on the volume of vaccine to be administered. The volume of the diluent was ≥0.5 mL; therefore, after reconstitution of the vaccine, the volume of the solution to be administered could vary from 0.49 to 0.57 mL.
    15 Apr 2010
    Updated information provided in the protocol and Informed Consent Form to ensure consistency across documents submitted to the Independent Ethics Committee and to French Health Authority.

    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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