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    Clinical Trial Results:
    Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China

    Summary
    EudraCT number
    2015-005194-20
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    10 Mar 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    20 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VRV08
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01339312
    WHO universal trial number (UTN)
    U1111-1117-7193
    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 54 76, ada-maria.minutello@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 54 76, ada-maria.minutello@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
    15 Aug 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of subjects with a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 14, i.e. before the fourth injection, in subjects aged 10 to 17 years and in subjects aged 18 years and over.
    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
    17 Apr 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: 816
    Worldwide total number of subjects
    816
    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)
    176
    Adolescents (12-17 years)
    232
    Adults (18-64 years)
    408
    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 17 April 2011 to 07 August 2011 at 1 clinic center in China.

    Pre-assignment
    Screening details
    A total of 816 subjects who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. Two subjects randomized to receive VRVg received Verorab for the 1st injection and were therefore included in the Verorab group for safety analysis.

    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
    This was an observer-blind study. Subjects were blinded to which vaccine was administered. Only the person who prepared and administered the vaccine remained unblinded. To maintain the blind, the person who administered the vaccine was different from the person who assessed safety to avoid bias in safety collection. In the event of an emergency (i.e., serious adverse event) the code could be broken as explained in the code-breakding procedures by the Investigator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    VRVg
    Arm description
    Subjects received a total of 5 Purified Vero Rabies Vaccine - Serum Free (VRVg) vaccine injections.
    Arm type
    Experimental

    Investigational medicinal product name
    Purified Vero Rabies Vaccine - Serum Free (VRVg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular (alternating between the left and right deltoid for each injection, starting with the left deltoid for the first injection), 1 injection each on Day 0, 3, 7, 14, and 28 (for a total of 5 injections)

    Arm title
    Verorab
    Arm description
    Subjects received a total of 5 Purified Vero Rabies Vaccine (Verorab) vaccine injections.
    Arm type
    Active comparator

    Investigational medicinal product name
    Purified Vero Rabies Vaccine (Verorab Vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular (alternating between the left and right deltoid for each injection, starting with the left deltoid for the first injection), 1 injection each on Day 0, 3, 7, 14, and 28 (for a total of 5 injections)

    Number of subjects in period 1
    VRVg Verorab
    Started
    542
    274
    Completed
    540
    273
    Not completed
    2
    1
         Adverse event, non-fatal
             1
             1
         Serious adverse event
             1
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VRVg
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine - Serum Free (VRVg) vaccine injections.

    Reporting group title
    Verorab
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine (Verorab) vaccine injections.

    Reporting group values
    VRVg Verorab Total
    Number of subjects
    542 274 816
    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)
    117 59 176
        Adolescents (12-17 years)
    155 77 232
        Adults (18-64 years)
    270 138 408
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28.1 ± 17.2 28.4 ± 17.21 -
    Gender categorical
    Units: Subjects
        Female
    326 171 497
        Male
    216 103 319

    End points

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    End points reporting groups
    Reporting group title
    VRVg
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine - Serum Free (VRVg) vaccine injections.

    Reporting group title
    Verorab
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine (Verorab) vaccine injections.

    Primary: Percentage of Healthy Subjects 10 to 17 Years Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Three Vaccinations with Either Purified Vero Rabies Vaccine – Serum Free or the Reference Purified Vero Rabies Vaccine

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    End point title
    Percentage of Healthy Subjects 10 to 17 Years Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Three Vaccinations with Either Purified Vero Rabies Vaccine – Serum Free or the Reference Purified Vero Rabies Vaccine
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method. Seroconversion was defined as rabies virus neutralizing antibody (RVNA) titers ≥0.5 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 14 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    245
    126
    Units: Percentage of subjects
    number (not applicable)
        Subjects with RVNA titers ≥ 0.5 IU/mL
    100
    100
    Statistical analysis title
    Non-inferiority (VRVg-Verorab; Day 14)
    Statistical analysis description
    This was a non-inferiority analysis of the immunogenicity of VRVg vs Verorab, in terms of proportion of subjects with an RVNA titer ≥0.5 IU/mL.
    Comparison groups
    VRVg v Verorab
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Difference in proportions (VRVg-Verorab)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.54
         upper limit
    2.96
    Notes
    [1] - Non-inferiority was demonstrated if the lower limit of the 95% confidence interval of the difference VRVg - Verorab for proportion of subjects with RVNA titer ≥0.5 IU/mL is >-5.0%. VRG was non-inferior to Verorab.

    Primary: Percentage of Healthy Adult Subjects 18 Years and Older Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Three Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine

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    End point title
    Percentage of Healthy Adult Subjects 18 Years and Older Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Three Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method. Seroconversion was defined as rabies virus neutralizing antibody (RVNA) titers ≥0.5 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 14 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    254
    125
    Units: Percentage of subjects
    number (not applicable)
        Subjects with RVNA titers ≥ 0.5 IU/mL
    99.6
    99.2
    Statistical analysis title
    Non-inferiority (VRVg-Verorab; Day 14)
    Statistical analysis description
    This was a non-inferiority analysis of the immunogenicity of VRVg vs Verorab, in terms of proportion of subjects with an RVNA titer ≥0.5 IU/mL.
    Comparison groups
    VRVg v Verorab
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference in proportions (VRVg-Verorab)
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.51
         upper limit
    4.01
    Notes
    [2] - Non-inferiority was demonstrated if the lower limit of the 95% confidence interval of the difference VRVg - Verorab for proportion of subjects with RVNA titer ≥0.5 IU/mL is >-5.0%. VRG was non-inferior to Verorab.

    Secondary: Percentage of Healthy Subjects 10 to 17 Years Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL Before and Following Primary Series Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine

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    End point title
    Percentage of Healthy Subjects 10 to 17 Years Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL Before and Following Primary Series Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Reference Purified Vero Rabies Vaccine
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method. Seroconversion was defined as rabies virus neutralizing antibody (RVNA) titers ≥0.5 IU/mL.
    End point type
    Secondary
    End point timeframe
    Day 42 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    272
    136
    Units: Percentage of subjects
    number (not applicable)
        Subjects with RVNA titers ≥ 0.5 IU/mL
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Adult Subjects 18 Years and Older Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Primary Series Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine

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    End point title
    Percentage of Healthy Adult Subjects 18 Years and Older Achieving Rabies Virus Neutralizing Antibodies (RVNA) Titer ≥ 0.5 IU/mL After Primary Series Vaccinations with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method. Seroconversion was defined as rabies virus neutralizing antibody (RVNA) titers ≥0.5 IU/mL.
    End point type
    Secondary
    End point timeframe
    Day 42 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    272
    136
    Units: Percentage of subjects
    number (not applicable)
        Subjects with RVNA titers ≥ 0.5 IU/mL
    100
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Each Primary Series Vaccination with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Subjects Aged 10 to 17 Years

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    End point title
    Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) Following Each Primary Series Vaccination with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Subjects Aged 10 to 17 Years
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 14 and Day 42 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    272
    136
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Geometric mean; Day 0
    0.072 (0.07 to 0.073)
    0.073 (0.07 to 0.076)
        Geometric mean; Day 14
    7.26 (6.5 to 8.11)
    8.81 (7.6 to 10.2)
        Geometric mean; Day 42
    9.61 (8.6 to 10.7)
    11.8 (10.2 to 13.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) After Each Primary Series Vaccination with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adult Subjects Aged 18 Years and Older

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    End point title
    Geometric Mean Titers of Rabies Virus Neutralizing Antibodies (RVNA) After Each Primary Series Vaccination with Purified Vero Rabies Vaccine – Serum Free or Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adult Subjects Aged 18 Years and Older
    End point description
    Antibody titers to each vaccine were assessed using the rapid fluorescent focus inhibition test (RFFIT) method.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 14 and Day 42 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    272
    136
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Geometric mean; Day 0
    0.071 (0.07 to 0.072)
    0.072 (0.07 to 0.075)
        Geometric mean; Day 14
    2.75 (2.4 to 3.16)
    3.76 (3.12 to 4.55)
        Geometric mean; Day 42
    5.09 (4.52 to 5.74)
    5.72 (4.86 to 6.73)
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Subjects Reporting Solicited Injection-site or Systemic Reactions Following Any 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 Subjects Reporting Solicited Injection-site or Systemic Reactions Following Any Vaccination with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or The Reference Purified Vero Rabies Vaccine
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited injection site reactions (10 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, > 30 mm. Grade 3 Solicited injection site reactions (12 years and older): Pain, Significant, prevents daily activity; Erythema and Swelling, > 30 mm. Grade 3 Solicited systemic reactions: Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    540
    274
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain; All Subjects
    10.2
    12.4
        Grade 3 Injection site Pain; All Subjects
    0
    0.4
        Injection site Erythema; All Subjects
    2.2
    1.5
        Grade 3 Injection site Erythema; All Subjects
    0
    0.4
        Injection site Swelling; All Subjects
    0.9
    1.8
        Grade 3 Injection site Swelling; All Subjects
    0
    0.4
        Fever; All Subjects
    6.9
    6.8
        Grade 3 Fever; All Subjects
    0
    0.8
        Headache; All Subjects
    6.3
    6.9
        Grade 3 Headache; All Subjects
    0.2
    0.4
        Malaise; All Subjects
    5.6
    4
        Grade 3 Malaise; All Subjects
    0.2
    0
        Myalgia; All Subjects
    5.4
    4.4
        Grade 3 Myalgia; All Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Subjects Aged 10 to 17 Years Reporting Solicited Injection-site or Systemic Reactions Following Any 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 Subjects Aged 10 to 17 Years Reporting Solicited Injection-site or Systemic Reactions Following Any Vaccination with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or The Reference Purified Vero Rabies Vaccine
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited injection site reactions (10 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, > 30 mm. Grade 3 Solicited injection site reactions (12 years and older): Pain, Significant, prevents daily activity; Erythema and Swelling, > 30 mm. Grade 3 Solicited systemic reactions: Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    270
    136
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain; 10 to 17 years
    13.3
    14
        Grade 3 Injection site Pain; 10 to 17 years
    0
    0.7
        Injection site Erythema; 10 to 17 years
    3.3
    2.2
        Grade 3 Injection site Erythema; 10 to 17 years
    0
    0
        Injection site Swelling; 10 to 17 years
    1.9
    2.9
        Grade 3 Injection site Swelling; 10 to 17 years
    0
    0
        Fever; 10 to 17 years
    7.3
    8.4
        Grade 3 Fever; 10 to 17 years
    0
    1.5
        Headache; 10 to 17 years
    6.7
    5.9
        Grade 3 Headache; 10 to 17 years
    0.4
    0
        Malaise; 10 to 17 years
    5.9
    5.1
        Grade 3 Malaise; 10 to 17 years
    0.4
    0
        Myalgia; 10 to 17 years
    6.3
    5.9
        Grade 3 Myalgia; 10 to 17 years
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Healthy Subjects Aged 18 Year and Older Reporting Solicited Injection-site or Systemic Reactions Following Any 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 Subjects Aged 18 Year and Older Reporting Solicited Injection-site or Systemic Reactions Following Any Vaccination with Either Purified Vero Rabies Vaccine – Serum Free (VRVg) or The Reference Purified Vero Rabies Vaccine
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited injection site reactions (10 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, > 30 mm. Grade 3 Solicited injection site reactions (12 years and older): Pain, Significant, prevents daily activity; Erythema and Swelling, > 30 mm. Grade 3 Solicited systemic reactions: Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    VRVg Verorab
    Number of subjects analysed
    270
    138
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain; 18 Years and Over
    7
    10.9
        Grade 3 Injection site Pain; 18 Years and Over
    0
    0
        Injection site Erythema; 18 Years and Over
    1.1
    0.7
        Grade 3 Injection site Erythema; 18 Years and Over
    0
    0.7
        Injection site Swelling; 18 Years and Over
    0
    0.7
        Grade 3 Injection site Swelling; 18 Years and Over
    0
    0.7
        Fever; 18 Years and Over
    6.4
    5.3
        Grade 3 Fever; 18 Years and Over
    0
    0
        Headache; 18 Years and Over
    5.9
    8
        Grade 3 Headache; 18 Years and Over
    0
    0.7
        Malaise; 18 Years and Over
    5.2
    2.9
        Grade 3 Malaise; 18 Years and Over
    0
    0
        Myalgia; 18 Years and Over
    4.4
    2.9
        Grade 3 Myalgia; 18 Years and Over
    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 up to Day 28 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    VRVg
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine - Serum Free (VRVg) vaccine injections.

    Reporting group title
    Verorab
    Reporting group description
    Subjects received a total of 5 Purified Vero Rabies Vaccine (Verorab) vaccine injections.

    Serious adverse events
    VRVg Verorab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 274 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    55 / 542 (10.15%)
    34 / 274 (12.41%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 542 (6.27%)
    19 / 274 (6.93%)
         occurrences all number
    34
    19
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 542 (10.15%)
    34 / 274 (12.41%)
         occurrences all number
    55
    34
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 542 (6.64%)
    18 / 274 (6.57%)
         occurrences all number
    36
    18
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 542 (5.54%)
    11 / 274 (4.01%)
         occurrences all number
    30
    11
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 542 (5.35%)
    12 / 274 (4.38%)
         occurrences all number
    29
    12

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Apr 2011
    Exclusion criteria were modified and included clarification on non-inclusion of patients who self-reported seropositivity to hepatitis B, updated contraindications, and a more specific definition of bites by suspected rabid animals.
    08 Jul 2011
    The sample size was increased (due to an increase in the percentage of non-evaluable subjects) in order to appropriately assess the primary objective of the study.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/24148575
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