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    Clinical Trial Results:
    A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

    Summary
    EudraCT number
    		 2010-023858-37
    Trial protocol
    		 DE  
    Global end of trial date
    08 Sep 2011

    Results information
    Results version number
    		 v1
    This version publication date
    11 May 2016
    First version publication date
    28 Dec 2014
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P22E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01345721
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccine and Diagnostics
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Novartis Vaccines, Novartis Vaccines, anh.phung@novartis.com
    Scientific contact
    Novartis Vaccines, Novartis Vaccines, anh.phung@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
    03 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Co-primary objectives: 1.To evaluate the persistence of the antibody response in children previously vaccinated with one or two doses of MenACWY or MenC in study V59P22, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W and Y. 2.To evaluate the antibody response to a booster dose of MenACWY in children previously vaccinated with one or two doses of MenACWY as measured by of percentage of subjects with hSBA titers ≥ 1:8, and hSBA GMTs directed against N.meningitidis serogroups A, C, W, Y. 3.To evaluate the antibody response to one dose of MenACWY in children previously vaccinated with MenC as measured by of percentage of subjects with hSBA titers ≥ 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C, W, Y. Safety Objective: To assess the safety and tolerability of a dose of MenACWY in subjects who were previously vaccinated with one or two doses of MenACWY or MenC.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.
    Background therapy
    		 MenACWY
    Evidence for comparator
    		 MenC
    Actual start date of recruitment
    25 May 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
    Germany: 205
    Worldwide total number of subjects
    205
    EEA total number of subjects
    205
    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)
    205
    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 for this extension study were enrolled between 25 May 2011 and 08 September 2011 from only sites in Germany that participated in the parent study.

    Pre-assignment
    Screening details
    		 Subjects were 22 to 45 months of age at the time of enrolment into V59P22E1 and had participated in the original V59P22 study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY_2 doses + MenACWY booster
    Arm description
    		 Subjects, who had received two doses of MenACWY (at 6 to 8 months and 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-CRM
    Investigational medicinal product code
    Other name
    Meningococcal (groups A, C, Y, and W-135 vaccine) Oligosaccharide Diptheria-CRM197 Conjugate Vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY was obtained by extemporaneous mixing just before injection of the lyophilized MenA component with the liquid MenCWY component. One 0.5 mL dose of MenACWY was administered by IM injection in the left deltoid.

    Arm title
    		 MenACWY_1 dose + MenACWY booster
    Arm description
    		 Subjects, who had received one dose of MenACWY (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-CRM
    Investigational medicinal product code
    Other name
    Meningococcal (groups A, C, Y, and W-135 vaccine) Oligosaccharide Diptheria-CRM197 Conjugate Vaccine
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY was obtained by extemporaneous mixing just before injection of the lyophilized MenA component with the liquid MenCWY component. One 0.5 mL dose of MenACWY was administered by IM injection in the left deltoid.

    Arm title
    		 Men C + MenACWY booster
    Arm description
    		 Subjects, who had received one dose of the comparator MenC vaccine (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-CRM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY was obtained by extemporaneous mixing just before injection of the lyophilized MenA component with the liquid MenCWY component. One 0.5 mL dose of MenACWY was administered by IM injection in the left deltoid.

    Number of subjects in period 1
    		MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster
    Started
    74
    66
    65
    Completed
    74
    66
    65

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY_2 doses + MenACWY booster
    Reporting group description
    		 Subjects, who had received two doses of MenACWY (at 6 to 8 months and 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Reporting group title
    MenACWY_1 dose + MenACWY booster
    Reporting group description
    		 Subjects, who had received one dose of MenACWY (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Reporting group title
    Men C + MenACWY booster
    Reporting group description
    		 Subjects, who had received one dose of the comparator MenC vaccine (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Reporting group values
    		 MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster Total
    Number of subjects
    		 74 66 65 205
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 74 66 65 205
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 36.7 ± 5.3 37.4 ± 5.6 37.9 ± 5.3 -
    Gender categorical
    Units: Subjects
        Female
    		 34 30 37 101
        Male
    		 40 36 28 104
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who received at least one dose of study vaccine, and provided some post-vaccination safety data

    Subject analysis set title
    Per Protocol Persistence Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who provided evaluable serum samples at visit 7 and had no major protocol violation as defined prior to the end of the study

    Subject analysis sets values
    		 Safety Population Per Protocol Persistence Population
    Number of subjects
    140
    136
    Age categorical
    Units: Subjects
        Children (2-11 years)
    140
    136
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    MenACWY_2 doses + MenACWY booster
    Reporting group description
    		 Subjects, who had received two doses of MenACWY (at 6 to 8 months and 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Reporting group title
    MenACWY_1 dose + MenACWY booster
    Reporting group description
    		 Subjects, who had received one dose of MenACWY (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Reporting group title
    Men C + MenACWY booster
    Reporting group description
    		 Subjects, who had received one dose of the comparator MenC vaccine (at 12 months of age) in the parent study, were administered a booster dose of MenACWY at 22 to 45 months of age in this extension study.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who received at least one dose of study vaccine, and provided some post-vaccination safety data

    Subject analysis set title
    Per Protocol Persistence Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who provided evaluable serum samples at visit 7 and had no major protocol violation as defined prior to the end of the study

    Primary: Percentage of Subjects with Human Serum Bactericidal Antibody Titer ≥1:8 by Time Since the Last Dose of Primary Vaccination

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    End point title
    		 Percentage of Subjects with Human Serum Bactericidal Antibody Titer ≥1:8 by Time Since the Last Dose of Primary Vaccination [1]
    End point description
    Booster response is presented as the percentage of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y at visit 7 prior to the MenACWY dose on day 1 in study V59P22E1. Persistence was summarized by time period since the last vaccination in the parent study, V59P22 (time intervals of ≤23 months, 24 to 31 months, and ≥32 months since last vaccination).
    End point type
    Primary
    End point timeframe
    13-33 months post-primary 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 hypotheses associated with the co-primary or secondary immunogenicity objectives. All analyses were run descriptively.
    End point values
    		 MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster
    Number of subjects analysed
    52
    41
    43
    Units: Percentage of Subjects
    number (confidence interval 95%)
        ≤23 Months – MenA (25,17,19)
    16 (5 to 36)
    6 (0 to 29)
    0 (0 to 18)
        ≤23 Months – MenC (25,16,18)
    36 (18 to 57)
    38 (15 to 65)
    44 (22 to 69)
        ≤23 Months – MenW (25,17,19)
    48 (28 to 69)
    76 (50 to 93)
    21 (6 to 46)
        ≤23 Months – MenY (25,17,19)
    40 (21 to 61)
    53 (28 to 77)
    5 (0 to 26)
        24-31 Months – MenA (26,22,14)
    12 (2 to 30)
    9 (1 to 29)
    0 (0 to 14)
        24-31 Months – MenC (26,22,14)
    19 (7 to 39)
    14 (3 to 35)
    29 (13 to 51)
        24-31 Months – MenW (26,22,24)
    54 (33 to 73)
    55 (32 to 76)
    4 (0 to 21)
        24-31 Months- MenY (26,22,24)
    38 (20 to 59)
    27 (11 to 50)
    29 (13 to 51)
        ≥32 Months – MenA (1,2,0)
    0 (0 to 98)
    0 (0 to 84)
    0 (0 to 0)
        ≥32 Months – MenC (1,2,0)
    0 (0 to 98)
    50 (1 to 99)
    0 (0 to 0)
        ≥32 Months – MenW (1,2,0)
    0 (0 to 98)
    50 (1 to 99)
    0 (0 to 0)
        ≥32 Months – MenY (1,2,0)
    100 (3 to 100)
    50 (1 to 99)
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with human Serum Bactericidal Antibody Titer ≥1:8 at 1 Month after Booster

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    End point title
    		 Percentage of Subjects with human Serum Bactericidal Antibody Titer ≥1:8 at 1 Month after Booster [2]
    End point description
    Booster response is presented as the percentage of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y at visit 7 prior to the MenACWY dose on day 1 in study V59P22E1 and at visit 8 one month after.
    End point type
    Primary
    End point timeframe
    1 month post-booster 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 hypotheses associated with the co-primary or secondary immunogenicity objectives. All analyses were run descriptively.
    End point values
    		 MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster
    Number of subjects analysed
    52
    41
    43
    Units: Percentage of Subjects
    number (confidence interval 95%)
        MenA – pre-booster (52,41,41)
    13 (6 to 26)
    7 (2 to 20)
    0 (0 to 9)
        MenA – 1 month post-booster (52,41,41)
    96 (87 to 100)
    98 (87 to 100)
    61 (45 to 76)
        MenC – pre-booster (52,40,39)
    27 (16 to 41)
    25 (13 to 41)
    36 (21 to 53)
        MenC – 1 month post-booster (52,40,39)
    100 (93 to 100)
    100 (91 to 100)
    100 (91 to 100)
        MenW– pre-booster (52,41,41)
    50 (36 to 64)
    63 (47 to 78)
    12 (4 to 26)
        MenW– 1 month post-booster (52,41,41)
    100 (93 to 100)
    100 (91 to 100)
    95 (83 to 99)
        MenY– pre-booster (52,41,41)
    40 (27 to 55)
    39 (24 to 55)
    20 (9 to 35)
        MenY– 1 month post-booster (52,41,41)
    100 (93 to 100)
    100 (91 to 100)
    95 (83 to 99)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Human Serum Bactericidal Antibodies at 1 Month after Booster

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    End point title
    		 Geometric Mean Titers of Human Serum Bactericidal Antibodies at 1 Month after Booster [3]
    End point description
    hSBA geometric mean titers (GMTs) for N. meningitidis serogroups A, C, W-135, and Y, measured before and after the booster dose.
    End point type
    Primary
    End point timeframe
    1 month post-booster vaccination
    Notes
    [3] - 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 hypotheses associated with the co-primary or secondary immunogenicity objectives. All analyses were run descriptively.
    End point values
    		 MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster
    Number of subjects analysed
    52
    41
    43
    Units: Titers
    geometric mean (confidence interval 95%)
        MenA – pre-booster (52,41,41)
    2.82 (2.35 to 3.38)
    2.52 (2.05 to 3.09)
    2 (1.63 to 2.45)
        MenA – 1 month post-booster (52,41,41)
    182 (118 to 281)
    214 (131 to 350)
    20 (12 to 32)
        MenC –pre-booster (52,40,39)
    3.92 (2.92 to 5.26)
    3.91 (2.79 to 5.48)
    4.83 (3.44 to 6.77)
        MenC – 1 month post-booster (52,40,39)
    541 (399 to 733)
    968 (682 to 1372)
    1530 (1077 to 2173)
        MenW–pre-booster (52,41,41)
    9.37 (6.3 to 14)
    12 (7.51 to 18)
    2.82 (1.81 to 4.39)
        MenW– 1 month post-booster (52,41,41)
    799 (564 to 1133)
    1267 (854 to 1879)
    54 (37 to 80)
        MenY–pre-booster (52,41,41)
    6.79 (4.86 to 9.5)
    6.04 (4.13 to 8.82)
    3.05 (2.09 to 4.44)
        MenY– 1 month post-booster (52,41,41)
    650 (448 to 941)
    676 (444 to 1027)
    54 (35 to 81)
    No statistical analyses for this end point

    Secondary: Subjects Reporting Local and Systemic Reactions during 7-Day Period after Booster Vaccination

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    End point title
    		 Subjects Reporting Local and Systemic Reactions during 7-Day Period after Booster Vaccination
    End point description
    The number of subjects with solicited local and systemic reactions within 7 days after booster vaccination with MenACWY.
    End point type
    Secondary
    End point timeframe
    Day 1 to 7 after vaccination
    End point values
    		 MenACWY_2 doses + MenACWY booster MenACWY_1 dose + MenACWY booster Men C + MenACWY booster
    Number of subjects analysed
    53
    44
    43
    Units: Number of Subjects
    number (not applicable)
        Local reactions
    17
    21
    19
        Pain
    10
    15
    13
        Erythema
    14
    17
    15
        Induration
    6
    8
    7
        Systemic reactions
    28
    18
    25
        Arthralgia
    1
    5
    4
        Headache
    5
    6
    1
        Vomiting
    0
    2
    1
        Change in Eating Habits
    6
    8
    6
        Rash
    0
    2
    1
        Sleepiness
    10
    13
    10
        Fever
    8
    7
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local and systemic reactions and all adverse events (AEs) were collected from day 1 to day 7.. From day 8 after booster vaccination to visit 8, medically-attended AEs were recorded.Serious Adverse Events (SAEs) were collected throughout the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Men ACWY_1 dose
    Reporting group description
    		 Subjects who received one dose of MenACWY at 12 months of age, and who were administered a booster dose of MenACWY at 22 to 45 months of age

    Reporting group title
    Men ACWY_2 doses
    Reporting group description
    		 Subjects who received two doses of MenACWY, one at 6 to 8 months and another at 12 months of age, and who were administered a booster dose of MenACWY at 22 to 45 months of age.

    Reporting group title
    Men C
    Reporting group description
    		 Subjects who received one dose of Menjugate (MenC) at 12 months of age, and who were administered a booster dose of MenACWY at 22 to 45 months of age

    Serious adverse events
    		 Men ACWY_1 dose Men ACWY_2 doses Men C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 53 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Men ACWY_1 dose Men ACWY_2 doses Men C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 44 (70.45%)
    33 / 53 (62.26%)
    30 / 43 (69.77%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 44 (29.55%)
    10 / 53 (18.87%)
    10 / 43 (23.26%)
         occurrences all number
    15
    11
    10
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 44 (13.64%)
    5 / 53 (9.43%)
    1 / 43 (2.33%)
         occurrences all number
    6
    5
    1
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    8 / 44 (18.18%)
    12 / 53 (22.64%)
    14 / 43 (32.56%)
         occurrences all number
    9
    13
    16
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 44 (18.18%)
    8 / 53 (15.09%)
    7 / 43 (16.28%)
         occurrences all number
    9
    11
    10
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 44 (38.64%)
    14 / 53 (26.42%)
    15 / 43 (34.88%)
         occurrences all number
    17
    14
    15
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 44 (18.18%)
    6 / 53 (11.32%)
    7 / 43 (16.28%)
         occurrences all number
    8
    6
    7
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 44 (34.09%)
    10 / 53 (18.87%)
    13 / 43 (30.23%)
         occurrences all number
    16
    10
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 44 (4.55%)
    4 / 53 (7.55%)
    8 / 43 (18.60%)
         occurrences all number
    3
    6
    9
    Psychiatric disorders
    Eating disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 44 (18.18%)
    6 / 53 (11.32%)
    6 / 43 (13.95%)
         occurrences all number
    10
    6
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 44 (11.36%)
    1 / 53 (1.89%)
    4 / 43 (9.30%)
         occurrences all number
    5
    1
    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.
    1 site was excluded as not compliant with the protocol requirements for safety reporting,(65 subjects [21 subjects in MenACWY 2-dose group, 22 subjects in MEnACWY 1-dose group and 22 subjects in MenC 1-dose group])
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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