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    Clinical Trial Results:
    Immunogenicity of DTaP-IPV-Hep B-PRP-T Combined Vaccine Compared with PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

    Summary
    EudraCT number
    2011-004454-26
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    18 Jun 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    12 Sep 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L10
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00315055
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001201-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    30 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immune response to Hep B antigen of the DTaP-IPV-Hep B-PRP-T is non-inferior to that of the association of PENTAXIM™ + ENGERIX B® 1 month after a three-dose primary series at 2, 3, and 4 months of age.
    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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    All subjects participating in the study were to have received the DTaP-IPV-Hep B-PRP-T vaccine at 2, 3, and 4 months of age which is in agreement with the national immunization program in Turkey.
    Evidence for comparator
    PENTAXIM + ENGERIX B® vaccines were chosen as the control vaccines for this trial as they are part of the standard range of vaccines currently used in Turkey. In addition, PENTAXIM contains the same D, T, aP, IPV, and PRP-T antigens as the investigational vaccine while ENGERIX B® contains the same amount of HBsAg as the investigational vaccine.
    Actual start date of recruitment
    01 Jun 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Turkey: 310
    Worldwide total number of subjects
    310
    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)
    310
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.

    Pre-assignment
    Screening details
    A total of 310 subjects who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    DTaP-IPV-Hep B-PRP~T
    Arm description
    Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
    Arm type
    Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, one dose each at 2, 3, and 4 months of age.

    Arm title
    PENTAXIM™ and ENGERIX®
    Arm description
    Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
    Arm type
    Active comparator

    Investigational medicinal product name
    Pentaxim
    Investigational medicinal product code
    DTaP-IPV-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, one dose at 2, 3, and 4 months of age.

    Investigational medicinal product name
    ENGERIX B
    Investigational medicinal product code
    Recombinant Hep B vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, one dose each at 2, 3, and 4 months of age.

    Number of subjects in period 1
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Started
    155
    155
    Completed
    152
    150
    Not completed
    3
    5
         Protocol deviation
    2
    4
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T
    Reporting group description
    Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Reporting group title
    PENTAXIM™ and ENGERIX®
    Reporting group description
    Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Reporting group values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX® Total
    Number of subjects
    155 155 310
    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)
    155 155 310
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    2.08 ± 0.09 2.08 ± 0.102 -
    Gender categorical
    Units: Subjects
        Female
    67 72 139
        Male
    88 83 171

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T
    Reporting group description
    Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Reporting group title
    PENTAXIM™ and ENGERIX®
    Reporting group description
    Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Primary: Percentage of Subjects With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines

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    End point title
    Percentage of Subjects With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines [1]
    End point description
    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.
    End point type
    Primary
    End point timeframe
    Day 90 post first dose
    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 / study vaccine administered for this outcome.
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    134
    128
    Units: Percentage of subjects
        Percentage of Subjects With Seroprotection
    94
    96
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®

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    End point title
    Percentage of Subjects With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
    End point description
    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.
    End point type
    Secondary
    End point timeframe
    Day 90 post first dose
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    145
    141
    Units: Percentage of subjects
        Anti-HBs (≥ 100 mIU/mL)
    65
    78
        Anti-PRP (≥ 0.15 µg/mL)
    91
    98
        Anti-PRP (≥ 1.0 µg/mL)
    73
    77
        Anti-Diphtheria (≥0.01 IU/mL)
    99
    97
        Anti-Diphtheria (≥0.1 IU/mL)
    34
    44
        Anti-Tetanus (≥0.01 IU/mL)
    100
    100
        Anti-Tetanus (≥0.1 IU/mL)
    100
    99
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

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    End point title
    Percentage of Subjects With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
    End point description
    Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.
    End point type
    Secondary
    End point timeframe
    Day 90 post first dose
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    145
    141
    Units: Percentage of subjects
        Anti-Polio 1
    98
    98
        Anti-Polio 2
    95
    94
        Anti-Polio 3
    97
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

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    End point title
    Percentage of Subjects With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
    End point description
    Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-dose 3
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    145
    141
    Units: Percentage of subjects
        Anti-PT (Pre-dose 1)
    55
    48
        Anti-PT (Post-dose 3)
    100
    100
        Anti-FHA (Pre-dose 1)
    65
    62
        Anti-FHA (Post-dose 3)
    100
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

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    End point title
    Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
    End point description
    Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.
    End point type
    Secondary
    End point timeframe
    Day 90 (30 Days post-dose 3)
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    145
    141
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-HBs
    149 (115 to 191)
    265 (205 to 342)
        Anti-PRP
    2.12 (1.62 to 2.77)
    2.37 (1.91 to 2.94)
        Anti-Diphtheria
    0.071 (0.06 to 0.084)
    0.091 (0.075 to 0.11)
        Anti-Tetanus
    0.839 (0.731 to 0.962)
    0.709 (0.625 to 0.804)
        Anti-Polio 1
    102 (74.9 to 138)
    112 (85.4 to 147)
        Anti-Polio 2
    73.5 (52.9 to 102)
    78.2 (58.2 to 105)
        Anti-Polio 3
    133 (93 to 190)
    214 (159 to 288)
        Anti-PT
    123 (109 to 139)
    138 (122 to 155)
        Anti-FHA
    102 (90.4 to 114)
    69.3 (62 to 77.6)
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®

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    End point title
    Number of Subjects With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 7 post any dose
    End point values
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Number of subjects analysed
    153
    152
    Units: Subjects
    number (not applicable)
        Injection site Pain Post-dose 1
    70
    55
        Injection site Pain Post-dose 2
    66
    58
        Injection site Pain Post-dose 3
    57
    48
        Injection site Erythema Post-dose 1
    23
    17
        Injection site Erythema Post-dose 2
    25
    17
        Injection site Erythema Post-dose 3
    30
    17
        Injection site Swelling Post-dose 1
    21
    16
        Injection site Swelling Post Dose 2
    21
    12
        Injection site Sweling Post Dose 3
    17
    11
        Pyrexia Post-dose 1
    15
    12
        Pyrexia Post-dose 2
    33
    23
        Pyrexia Post-dose 3
    41
    24
        Vomiting Post-dose 1
    57
    44
        Vomiting Post-dose 2
    55
    48
        Vomiting Post-dose 3
    44
    40
        Crying Post-dose 1
    51
    41
        Crying Post-dose 2
    54
    38
        Crying Post-dose 3
    45
    30
        Somnolence Post-dose 1
    51
    45
        Somnolence Post-dose 2
    35
    38
        Somnolence Post-dose 3
    26
    36
        Anorexia Post-dose 1
    43
    27
        Anorexia Post-dose 2
    48
    35
        Anorexia Post-dose 3
    42
    40
        Irritability Post-dose 1
    83
    67
        Irritability Post-dose 2
    81
    74
        Irritability Post-dose 3
    71
    64
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T
    Reporting group description
    Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Reporting group title
    PENTAXIM™ and ENGERIX®
    Reporting group description
    Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).

    Serious adverse events
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 153 (1.31%)
    3 / 152 (1.97%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 152 (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
    DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    83 / 153 (54.25%)
    74 / 152 (48.68%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    51 / 153 (33.33%)
    45 / 152 (29.61%)
         occurrences all number
    51
    45
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    70 / 153 (45.75%)
    58 / 152 (38.16%)
         occurrences all number
    70
    58
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 153 (19.61%)
    17 / 152 (11.18%)
         occurrences all number
    30
    17
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 153 (13.73%)
    16 / 152 (10.53%)
         occurrences all number
    21
    16
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    83 / 153 (54.25%)
    74 / 152 (48.68%)
         occurrences all number
    83
    74
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 153 (26.80%)
    24 / 152 (15.79%)
         occurrences all number
    41
    24
    Psychiatric disorders
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 153 (35.29%)
    41 / 152 (26.97%)
         occurrences all number
    54
    41
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    57 / 153 (37.25%)
    48 / 152 (31.58%)
         occurrences all number
    57
    48
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed
    48 / 153 (31.37%)
    40 / 152 (26.32%)
         occurrences all number
    48
    40

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2006
    Prior to the enrollment of subjects in the study, the protocol was updated to include (i) the incorporation of an Independent Data Monitoring Committee (ii) the requirements for collection of baseline, immunogenicity, and safety data and analysis.
    16 Apr 2007
    A modification to remove all study procedures related to the booster vaccination, include another secondary immunogenicity assessment, and a change to the type of assays used to detect antibody levels at qualified contract laboratories.

    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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