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    Clinical Trial Results:
    Evaluating the safeness of Agrippal S1 in preventing flu on Vietnamese volunteers.

    Summary
    EudraCT number
    2014-005128-91
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    04 Mar 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    03 May 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC project because of the EudraCT system glitch and possible updates to results may be required. Moreover, a change in system user for this study is necessary.
    Summary report(s)
    V71_21 CTRD 13 Apr 15

    Trial information

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    Trial identification
    Sponsor protocol code
    V71_21
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01123954
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.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
    27 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of a single 0.5mL dose of Agrippal S1 administered to Vietnamese volunteers.
    Protection of trial subjects
    This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study is conducted, and applicable standard operating procedures (SOPs). The benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the trial did not find the hazards to outweigh the potential benefits.
    Background therapy
    N/A
    Evidence for comparator
    N/A
    Actual start date of recruitment
    29 Jan 2010
    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
    Vietnam: 33
    Worldwide total number of subjects
    33
    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)
    1
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled at 1 center in Vietnam.

    Pre-assignment
    Screening details
    All subjects enrolled were included in the trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    The trial was designed as a single-arm, open-label study.

    Arms
    Arm title
    Agrippal
    Arm description
    Subjects received a single 0.5mL dose of Agrippal S1.
    Arm type
    Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine (surface antigen, inactivated, egg derived)
    Investigational medicinal product code
    Agrippal
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of 0.5 mL

    Number of subjects in period 1
    Agrippal
    Started
    33
    Completed
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Agrippal
    Reporting group description
    Subjects received a single 0.5mL dose of Agrippal S1.

    Reporting group values
    Agrippal Total
    Number of subjects
    33 33
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    1 1
        Adolescents (12-17 years)
    1 1
        Adults (18-64 years)
    31 31
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.48 ± 9.34 -
    Gender categorical
    Units: Subjects
        Female
    12 12
        Male
    21 21
    Subject analysis sets

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All enrolled subjects.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All enrolled subjects were included in the safety set.

    Subject analysis sets values
    Enrolled Set Safety Set
    Number of subjects
    33
    33
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    1
    1
        Adolescents (12-17 years)
    1
    1
        Adults (18-64 years)
    31
    31
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.48 ± 9.34
    26.48 ± 9.34
    Gender categorical
    Units: Subjects
        Female
    12
    12
        Male
    21
    21

    End points

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    End points reporting groups
    Reporting group title
    Agrippal
    Reporting group description
    Subjects received a single 0.5mL dose of Agrippal S1.

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All enrolled subjects.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All enrolled subjects were included in the safety set.

    Primary: Number of subjects reporting solicited local and systemic reactions during the 7 days following one dose of Agrippal S1

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    End point title
    Number of subjects reporting solicited local and systemic reactions during the 7 days following one dose of Agrippal S1 [1]
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after the vaccination with of Agrippal S1. Analysis performed on the safety set.
    End point type
    Primary
    End point timeframe
    Within 30 minutes after vaccination and for 7 days after 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: There were no statistical analysis done.
    End point values
    Agrippal
    Number of subjects analysed
    33
    Units: Number of subjects
        Any Reaction
    13
        Any Local Reaction
    11
        Any Systemic Reaction
    7
        Any Severe Reaction
    0
        Any Severe Local Reaction
    0
        Any Severe Systemic Reaction
    0
        Redness
    3
        Swelling
    1
        Injection site Pain 1 Pain when exposure
    8
        Injection site Pain 2 Pain that impacts the normal
    3
        Injection site Pain 3 Set obstacles to activities
    0
        Fever from 38.5°C included to 39 °C
    0
        Myalgia 1 Withstandable myalgia
    4
        Myalgia 2 impacts the normal activities
    2
        Myalgia 3 set obstacles to the normal activities
    0
        Arthralgia 1 Withstandable arthralgia
    1
        Arthralgia 2 impacts the normal activities
    0
        Arthralgia 3 set obstacles to normal activities
    0
        Malaise 1 Withstandable malaise
    0
        Malaise 2 impacts the normal activities
    0
        Malaise 3 set obstacles to the normal activities
    0
        Headache 1 Withstandable headache
    4
        Headache 2 impacts the normal activities
    0
        Headache 3 set obstacles to the normal activities
    0
        Nausea 1 Withstandable nausea
    0
        Nausea 2 impacts the normal activities
    0
        Nausea 3 set obstacles to the normal activities
    0
        Vomiting 1 Withstandable vomiting
    0
        Vomiting 2 impacts the normal activities
    0
        Vomiting 3 set obstacles to the normal activities
    0
        Diarrhea 1 Withstandable diarrhea
    0
        Diarrhea 2 impacts the normal activities
    0
        Diarrhea 3 set obstacles to the normal activities
    0
        Stomachache 1 Withstandable stomachache
    0
        Stomachache 2 impacts the normal activities
    0
        Stomachache 3 set obstacles to normal activities
    0
        Rash 1 Withstandable rash
    0
        Rash 2 impacts the normal activities
    0
        Rash 3 set obstacles to the normal activities
    0
        Urticaria 1 In 01 specific area
    0
        Urticaria 2 In 02 or 03 areas but not over 03
    0
        Urticaria 3 In at least 04 areas
    0
    No statistical analyses for this end point

    Primary: Number of subjects reporting any unsolicited adverse events (AEs) after receiving one dose of Agrippal S1.

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    End point title
    Number of subjects reporting any unsolicited adverse events (AEs) after receiving one dose of Agrippal S1. [2]
    End point description
    Safety was assessed as the number of subjects who reported unsolicited AEs up to approximately 30 days after the vaccination with of Agrippal S1. Analysis performed on the safety set.
    End point type
    Primary
    End point timeframe
    Approximately 30 days after 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: There were no statistical analysis done.
    End point values
    Agrippal
    Number of subjects analysed
    33
    Units: Number of subjects
        Any SAE
    0
        Any unsolicited AE
    0
        AEs leading to premature withdrawal
    0
        Deaths
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all other serious and non-serious AEs were collected for approximately 30 days after the vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Agrippal
    Reporting group description
    Subjects received a single 0.5mL dose of Agrippal S1.

    Serious adverse events
    Agrippal
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Agrippal
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 33 (39.39%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 33 (18.18%)
         occurrences all number
    6
    Injection site erythema
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Injection site pain
         subjects affected / exposed
    11 / 33 (33.33%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    6 / 33 (18.18%)
         occurrences all number
    6

    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.
    The data-sets in this third-country study were manually computed. Please refer to the report submitted to the Vietnamese health authority for information (attached in the summary attachment section).
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