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    Clinical Trial Results:
    An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C conjugate (MCC) vaccine in healthy infants

    Summary
    EudraCT number
    		 2006-005445-11
    Trial protocol
    		 FI  
    Global end of trial date
    23 Oct 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S06-ROT-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00443846
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur MSD S.N.C.
    Sponsor organisation address
    162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
    Public contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
    Scientific contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.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
    23 Oct 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that RotaTeq® can be administered concomitantly with MCC vaccine to healthy infants without impairing the antibody seroprotection rate to meningococcal Group C serotype as measured by serum bactericidal antibody with rabbit complement (rSBA) at 28 days following the last dose.
    Protection of trial subjects
    Healthy subjects with hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (MCC vaccine) (including tetanus toxoid) were not included. Vaccines were administered by qualified study personnel. After each vaccination, subjects were kept under observation for at least 20 minutes to ensure their safety.
    Background therapy
    		 -
    Evidence for comparator
    		 The primary objective of the study was to demonstrate that RotaTeq can be administered concomitantly with MCC vaccine without impairing the antibody responses to MCC vaccine in order to support the use of RotaTeq in countries in which MCC vaccine is administered routinely to infants. Thus, the study design allowed the assessment of concomitant versus sequential administration of RotaTeq and MCC vaccine when the MCC vaccine was given at the same age in both groups.
    Actual start date of recruitment
    13 Feb 2007
    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
    Finland: 247
    Worldwide total number of subjects
    247
    EEA total number of subjects
    247
    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)
    247
    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
    		 Study subjects were enrolled between 13 February 2007 and 4 April 2007 in 9 active centres in Finland.

    Pre-assignment
    Screening details
    		 249 subjects were screened. 247 subjects were randomised. 239 subjects were vaccinated. 230 subjects completed the study.

    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 as this study was open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Concomitant administration
    Arm description
    		 Subjects received the 2 study vaccines concomitantly: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 10-11 weeks of age, dose 2 at 20-21 weeks of age, and dose 3 at 24-25 weeks of age # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. Subjects were blood sampled (i) before vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RotaTeq®
    Investigational medicinal product code
    RotaTeq
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL, oral route, 3 doses: dose 1 at 10-11 weeks of age, dose 2 at 20-21 weeks of age, and dose 3 at 24-25 weeks of age.

    Investigational medicinal product name
    NeisVac-C®
    Investigational medicinal product code
    MCC
    Other name
    MCC vaccine
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (preferably anterolateral region of the thigh), 2 doses: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age.

    Arm title
    		 Sequential administration
    Arm description
    		 Subjects received the 2 study vaccines sequentially: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 6-7 weeks of age, dose 2 at 15-16 weeks of age, and dose 3 at 24-25 weeks of age, # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. # Subjects were blood sampled (i) before any vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    RotaTeq®
    Investigational medicinal product code
    RotaTeq
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL, oral route, 3 doses: dose 1 at 6-7 weeks of age, dose 2 at 15-16 weeks of age, and dose 3 at 24-25 weeks of age.

    Investigational medicinal product name
    NeisVac-C®
    Investigational medicinal product code
    MCC
    Other name
    MCC vaccine
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (preferably anterolateral region of the thigh), 2 doses: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age.

    Number of subjects in period 1
    		Concomitant administration Sequential administration
    Started
    124
    123
    Completed
    113
    117
    Not completed
    11
    6
         Adverse event, non-fatal
    1
    1
         Personal reason
    8
    3
         Subject not vaccinated, no blood sample drawn
    1
    -
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concomitant administration
    Reporting group description
    		 Subjects received the 2 study vaccines concomitantly: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 10-11 weeks of age, dose 2 at 20-21 weeks of age, and dose 3 at 24-25 weeks of age # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. Subjects were blood sampled (i) before vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.

    Reporting group title
    Sequential administration
    Reporting group description
    		 Subjects received the 2 study vaccines sequentially: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 6-7 weeks of age, dose 2 at 15-16 weeks of age, and dose 3 at 24-25 weeks of age, # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. # Subjects were blood sampled (i) before any vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.

    Reporting group values
    		 Concomitant administration Sequential administration Total
    Number of subjects
    		 124 123 247
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 124 123 247
    Age continuous
    Age in weeks at randomisation visit.
    Units: weeks
        arithmetic mean (standard deviation)
    		 7.1 ( 0.5 ) 7.2 ( 0.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 50 55 105
        Male
    		 74 68 142

    End points

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    End points reporting groups
    Reporting group title
    Concomitant administration
    Reporting group description
    		 Subjects received the 2 study vaccines concomitantly: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 10-11 weeks of age, dose 2 at 20-21 weeks of age, and dose 3 at 24-25 weeks of age # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. Subjects were blood sampled (i) before vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.

    Reporting group title
    Sequential administration
    Reporting group description
    		 Subjects received the 2 study vaccines sequentially: # 3 doses of RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) by oral route: dose 1 at 6-7 weeks of age, dose 2 at 15-16 weeks of age, and dose 3 at 24-25 weeks of age, # 2 doses of MCC vaccine (NeisVac-C = Meningococcal group C polysaccharide Conjugate vaccine adsorbed) by intramuscular route: dose 1 at 10-11 weeks of age, and dose 2 at 20-21 weeks of age. # Subjects were blood sampled (i) before any vaccination = pre-vaccination, (ii) 28 to 42 days following dose 2 of MCC vaccine = post-MCC vaccination, and (iii) 42 days ±3 days following dose 3 of RotaTeq = post-RotaTeq vaccination. Note: Routine pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae infections was preferably to be given at 10-11 and 20-21 weeks of age.

    Subject analysis set title
    Concomitant administration - visit 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who concomitantly received RotaTeq + MCC vaccine doses 1 at 10-11 weeks of age (visit 2) and who had safety follow-up data at visit 2.

    Subject analysis set title
    Sequential administration - visit 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received MCC vaccine dose 1 at 10-11 weeks of age (visit 2) and who had safety follow-up data at visit 2.

    Subject analysis set title
    Concomitant administration - visit 4
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who concomitantly received RotaTeq + MCC vaccine doses 2 at 20-21 weeks of age (visit 4) and who had safety follow-up data at visit 4.

    Subject analysis set title
    Sequential administration - visit 4
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received MCC vaccine dose 2 at 20-21 weeks of age (visit 4) and who had safety follow-up data at visit 4.

    Primary: Seroprotection rate for the meningococcal Group C (Men C) serotype 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq

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    End point title
    		 Seroprotection rate for the meningococcal Group C (Men C) serotype 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq
    End point description
    The immune response to MCC vaccine was measured by serum bactericidal antibody with rabbit complement (rSBA). Seroprotection rate for the meningococcal Group C (Men C) serotype, defined as Men C-rSBA titre ≥8 (1/dil), was determined 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq. Analysis was done on the Per Protocol Set for the MCC vaccine immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the MCC vaccine.
    End point type
    Primary
    End point timeframe
    1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    104
    106
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men C-rSBA titre ≥8 (1/dil)
    100 (96.5 to 100)
    100 (96.6 to 100)
    Statistical analysis title
    		 Non-inferiority for Men C seroprotection rate
    Statistical analysis description
    The estimate of the difference between Group 1 (concomitant administration) & Group 2 (sequential administration) seroprotection rates was calculated with its 2-sided 95% confidence interval (CI). If the lower bound of the 95% CI was greater than the non-inferiority margin, it was concluded that Group 1 seroprotection rate was non-inferior to the Group 2 one. Statistical analysis was based on the Miettinen & Nurminen method stratified by centre. Analysis was done on the PPS for MCC vaccine.
    Comparison groups
    Concomitant administration v Sequential administration
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 3.7
    Notes
    [1] - For Men C: # PPS for MCC vaccine, N=104, 106 (Groups 1 & 2) # Response rate based on Men C-rSBA titre ≥8 (1/dil) # Non-inferiority margin, -10%.

    Secondary: Percentage of subjects with anti-Men C antibody (Ab) titres ≥128 (1/dil) before vaccination and 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq

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    End point title
    		 Percentage of subjects with anti-Men C antibody (Ab) titres ≥128 (1/dil) before vaccination and 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq
    End point description
    Subjects were blood sampled before vaccination (pre-MCC vaccination), and 28 to 42 days following MCC vaccine dose 2, administered concomitantly or not with RotaTeq (post-MCC vaccination). Percentages of subjects with Men C-rSBA titres ≥128 (1/dil) pre- and post-MCC vaccination are presented hereafter. Analysis was done on the Per Protocol Set for the MCC vaccine immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the MCC vaccine.
    End point type
    Secondary
    End point timeframe
    # Pre-MCC vaccination: before administration of any study vaccines. # Post-MCC vaccination: 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    104
    106 [2]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Pre-MCC vaccination Men C-rSBA ≥128 (1/dil)
    1.9 (0.2 to 6.8)
    3.8 (1 to 9.5)
        Post-MCC vaccination Men C-rSBA ≥128 (1/dil)
    100 (96.5 to 100)
    99.1 (94.9 to 100)
    Notes
    [2] - Pre-MCC vaccination: 1 missing data (N=105)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres (GMT) of anti-Men C antibodies (Ab) pre-MCC vaccination and 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq

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    End point title
    		 Geometric Mean Titres (GMT) of anti-Men C antibodies (Ab) pre-MCC vaccination and 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq
    End point description
    Subjects were blood sampled before vaccination (pre-MCC vaccination), and 28 to 42 days following MCC vaccine dose 2, administered concomitantly or not with RotaTeq (post-MCC vaccination). Anti-Men C Ab titres expressed in reciprocal dilution units were measured by serum bactericidal antibody with rabbit complement (rSBA) pre- and post-MCC vaccination. Analysis was done on the Per Protocol Set for the MCC vaccine immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the MCC vaccine.
    End point type
    Secondary
    End point timeframe
    # Pre-MCC vaccination: before administration of any study vaccines. # Post-MCC vaccination: 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    104
    106 [3]
    Units: Titres
    geometric mean (confidence interval 95%)
        Pre-MCC vaccination Men C-rSBA GMT
    2.5 (2.1 to 2.9)
    2.6 (2.2 to 3.1)
        Post-MCC vaccination Men C-rSBA GMT
    1457.8 (1251.5 to 1698.2)
    1262.3 (1074.8 to 1482.5)
    Notes
    [3] - Pre-MCC vaccination: 1 missing data (N=105)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with ≥4-fold increase of Men C-rSBA antibody (Ab) titres from pre- to post-MCC vaccination, i.e. 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq

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    End point title
    		 Percentage of subjects with ≥4-fold increase of Men C-rSBA antibody (Ab) titres from pre- to post-MCC vaccination, i.e. 1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq
    End point description
    Subjects were blood sampled before vaccination (pre-MCC vaccination), and 28 to 42 days following dose 2 of MCC vaccine, administered concomitantly or not with RotaTeq (post-MCC vaccination). Anti-Men C Ab titres were measured by serum bactericidal antibody with rabbit complement (rSBA) pre- and post-MCC vaccination. Percentages of subjects with ≥4-fold increase of Men C-rSBA Ab titres from pre- to post-MCC vaccination are presented hereafter. Analysis was done on the Per Protocol Set for the MCC vaccine immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the MCC vaccine.
    End point type
    Secondary
    End point timeframe
    1 month after MCC vaccine dose 2, administered concomitantly or not with RotaTeq.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    104
    105
    Units: Percentage of subjects
    number (confidence interval 95%)
        Pre- to post-MCC vaccination ≥4-fold increase
    98.1 (93.2 to 99.8)
    98.1 (93.3 to 99.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres (GMT) of serum neutralising antibodies (SNA) to rotavirus serotypes G1, G2, G3, G4 & P1A and serum anti-rotavirus IgA 42 ±3 days following RotaTeq dose 3

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    End point title
    		 Geometric Mean Titres (GMT) of serum neutralising antibodies (SNA) to rotavirus serotypes G1, G2, G3, G4 & P1A and serum anti-rotavirus IgA 42 ±3 days following RotaTeq dose 3
    End point description
    # SNA titres to rotavirus serotypes G1, G2, G3, G4 & P1A expressed in dilution unit, and # serum anti-rotavirus IgA titres expressed in units/mL were measured 42 ±3 days following RotaTeq dose 3. Analysis was done on the Per Protocol Set for the RotaTeq immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the RotaTeq.
    End point type
    Secondary
    End point timeframe
    42 ±3 days following RotaTeq dose 3.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    98
    104
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-rotavirus G1 GMT (SNA)
    187.2 (148.8 to 235.5)
    211.4 (168.6 to 264.9)
        Anti-rotavirus G2 GMT (SNA)
    41.9 (33.7 to 52.2)
    44.3 (35.6 to 55.1)
        Anti-rotavirus G3 GMT (SNA)
    24.2 (18.8 to 31.1)
    25.5 (19.8 to 32.9)
        Anti-rotavirus G4 GMT (SNA)
    64.7 (51.1 to 82)
    76.4 (59.8 to 97.5)
        Anti-rotavirus P1A GMT (SNA)
    111.2 (88.3 to 140)
    124.3 (99.1 to 156)
        Anti-rotavirus IgA GMT
    290.6 (215.1 to 392.5)
    363.1 (290.3 to 454.2)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with ≥3-fold increase of SNA titres to rotavirus serotypes G1, G2, G3, G4 & P1A & serum anti-rotavirus IgA titres from pre- to post-RotaTeq vaccination, i.e. 42 days after RotaTeq dose 3

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    End point title
    		 Percentage of subjects with ≥3-fold increase of SNA titres to rotavirus serotypes G1, G2, G3, G4 & P1A & serum anti-rotavirus IgA titres from pre- to post-RotaTeq vaccination, i.e. 42 days after RotaTeq dose 3
    End point description
    Subjects were blood sampled before vaccination (pre-RotaTeq vaccination), and 42 ±3 days following RotaTeq dose 3 (post-RotaTeq vaccination). Percentages of subjects with ≥3-fold increase of SNA titres to rotavirus serotypes G1, G2, G3, G4 & P1A and serum anti-rotavirus IgA titres from pre- to post-RotaTeq vaccination are presented hereafter. Analysis was done on the Per Protocol Set for the RotaTeq immunogenicity evaluation, i.e. all randomised subjects excluding subjects with protocol deviation that might interfere with the immunogenicity evaluation of the RotaTeq.
    End point type
    Secondary
    End point timeframe
    42 ±3 days following RotaTeq dose 3.
    End point values
    		 Concomitant administration Sequential administration
    Number of subjects analysed
    98
    104
    Units: Percentage of subjects
    number (confidence interval 95%)
        G1 pre- to post-vaccination ≥3-fold increase
    57.1 (46.7 to 67.1)
    63.5 (53.4 to 72.7)
        G2 pre- to post-vaccination ≥3-fold increase
    33.7 (24.4 to 43.9)
    38.5 (29.1 to 48.5)
        G3 pre- to post-vaccination ≥3-fold increase
    33.7 (24.4 to 43.9)
    37.5 (28.2 to 47.5)
        G4 pre- to post-vaccination ≥3-fold increase
    44.9 (34.8 to 55.3)
    46.2 (36.3 to 56.2)
        P1A pre- to post-vaccination ≥3-fold increase
    32.7 (23.5 to 42.9)
    40.4 (30.9 to 50.5)
        IgA pre- to post-vaccination ≥3-fold increase
    96.9 (91.3 to 99.4)
    98.1 (93.2 to 99.8)
    No statistical analyses for this end point

    Secondary: Global summary of safety from D0 to D13 following visit 2 and visit 4

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    End point title
    		 Global summary of safety from D0 to D13 following visit 2 and visit 4
    End point description
    Adverse events (AEs) occurring following visit 2 (concomitant administration: RotaTeq + MCC vaccine doses 1; sequential administration: MCC vaccine dose 1 alone) & visit 4 (concomitant administration: RotaTeq + MCC vaccine doses 2; sequential administration: MCC vaccine dose 2 alone) were recorded as follows: # From D0 to D6: unsolicited MCC injection-site and solicited daily systemic (diarrhoea, vomiting & pyrexia: rectal temperature ≥38.1°C or fever without temperature measurement) AEs, # From D0 to D13: unsolicited systemic AEs. AEs at injection sites were always considered as related to MCC vaccine (ISRs). The investigator had to assess whether systemic AEs were vaccine-related systemic AEs or not. Analysis was done on the Safety Set at visit 2 (N=238) & Safety Set at visit 4 (N=235), i.e. all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data at visits 2 or 4. Note: “0” means “not applicable”.
    End point type
    Secondary
    End point timeframe
    Visit 2: from D0 to D13 following visit 2 (concomitant: RotaTeq + MCC vaccine doses 1; sequential: MCC vaccine dose 1 alone). Visit 4: from D0 to D13 following visit 4 (concomitant: RotaTeq + MCC vaccine doses 2; sequential: MCC vaccine dose 2 alone).
    End point values
    		 Concomitant administration - visit 2 Sequential administration - visit 2 Concomitant administration - visit 4 Sequential administration - visit 4
    Number of subjects analysed
    116
    122
    115
    120
    Units: Percentage of subjects
    number (confidence interval 95%)
        At least 1 AE (ISR or systemic AE) (D0-D13)
    78.4 (69.9 to 85.5)
    65.6 (56.4 to 73.9)
    60 (50.4 to 69)
    57.5 (48.1 to 66.5)
        At least 1 RotaTeq-related AE (D0-D13)
    65.5 (56.1 to 74.1)
    0 (0 to 0)
    42.6 (33.4 to 52.2)
    0 (0 to 0)
        At least 1 MCC-related AE (D0-D13)
    63.8 (54.4 to 72.5)
    54.9 (45.7 to 63.9)
    49.6 (40.1 to 59)
    54.2 (44.8 to 63.3)
        At least 1 MCC ISR (D0-D6)
    13.8 (8.1 to 21.4)
    8.2 (4 to 14.6)
    24.3 (16.8 to 33.2)
    21.7 (14.7 to 30.1)
        At least 1 systemic AE (D0-D13)
    75 (66.1 to 82.6)
    62.3 (53.1 to 70.9)
    53 (43.5 to 62.4)
    48.3 (39.1 to 57.6)
        At least 1 RotaTeq-related systemic AE (D0-D13)
    65.5 (56.1 to 74.1)
    0 (0 to 0)
    42.6 (33.4 to 52.2)
    0 (0 to 0)
        At least 1 MCC-related systemic AE (D0-D13)
    58.6 (49.1 to 67.7)
    50.8 (41.6 to 60)
    39.1 (30.2 to 48.7)
    42.5 (33.5 to 51.9)
        At least 1 solicited systemic AE (D0-D6)
    46.6 (37.2 to 56)
    29.5 (21.6 to 38.4)
    29.6 (21.4 to 38.8)
    26.7 (19 to 35.5)
        At least 1 RotaTeq-related solicited systemic AE
    44 (34.8 to 53.5)
    0 (0 to 0)
    27 (19.1 to 36)
    0 (0 to 0)
        At least 1 MCC-related solicited systemic AE
    28.4 (20.5 to 37.6)
    23.8 (16.5 to 32.3)
    22.6 (15.3 to 31.3)
    24.2 (16.8 to 32.8)
    No statistical analyses for this end point

    Secondary: Unsolicited injection-site reactions (ISRs) for MCC vaccine from D0 to D6 following visit 2 and visit 4

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    End point title
    		 Unsolicited injection-site reactions (ISRs) for MCC vaccine from D0 to D6 following visit 2 and visit 4
    End point description
    Unsolicited MCC injection-site adverse reactions (ISRs) were recorded from D0 to D6 following visit 2 (concomitant administration: RotaTeq + MCC vaccine doses 1 / sequential administration: MCC vaccine dose 1 alone) & visit 4 (concomitant administration: RotaTeq + MCC vaccine doses 2 / sequential administration: MCC vaccine dose 2 alone). AEs at injection sites were always considered as related to MCC vaccine (ISRs). Analysis was done on the Safety Set at visit 2 (N=238) & Safety Set at visit 4 (N=235), i.e. all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data at visits 2 or 4.
    End point type
    Secondary
    End point timeframe
    Visit 2: from D0 to D6 following visit 2 (concomitant: RotaTeq + MCC vaccine doses 1 / sequential: MCC vaccine dose 1 alone). Visit 4: from D0 to D6 following visit 4 (concomitant: RotaTeq + MCC vaccine doses 2 / sequential: MCC vaccine dose 2 alone).
    End point values
    		 Concomitant administration - visit 2 Sequential administration - visit 2 Concomitant administration - visit 4 Sequential administration - visit 4
    Number of subjects analysed
    116
    122
    115
    120
    Units: Percentage of subjects
    number (not applicable)
        Injection-site bruising
    0
    0.8
    0.9
    0
        Injection-site eczema
    0
    0
    0
    0.8
        Injection-site erythema
    6
    4.1
    19.1
    15.8
        Injection-site haematoma
    0.9
    0
    0
    0
        Injection-site haemorrhage
    0
    0.8
    0
    0.8
        Injection-site induration
    1.7
    0.8
    2.6
    5.8
        Injection-site nodule
    0
    0.8
    0
    0
        Injection-site pain
    5.2
    2.5
    4.3
    2.5
        Injection-site swelling
    1.7
    3.3
    4.3
    5.8
    No statistical analyses for this end point

    Secondary: Solicited systemic AEs from D0 to D6 following visit 2 and visit 4

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    End point title
    		 Solicited systemic AEs from D0 to D6 following visit 2 and visit 4
    End point description
    Solicited systemic AEs (diarrhoea, vomiting & pyrexia: rectal temperature ≥38.1°C or fever without temperature measurement) were recorded daily from D0 to D6 following visit 2 (concomitant administration: RotaTeq + MCC vaccine doses 1 / sequential administration: MCC vaccine dose 1 alone) & visit 4 (concomitant administration: RotaTeq + MCC vaccine doses 2 / sequential administration: MCC vaccine dose 2 alone). The investigator had to assess whether systemic AEs were vaccine-related systemic AEs or not. All (related and unrelated) are displayed here. Analysis was done on the Safety Set at visit 2 (N=238) & Safety Set at visit 4 (N=235), i.e. all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data at visits 2 or 4.
    End point type
    Secondary
    End point timeframe
    Visit 2: from D0 to D6 following visit 2 (concomitant: RotaTeq + MCC vaccine doses 1 / sequential: MCC vaccine dose 1 alone). Visit 4: from D0 to D6 following visit 4 (concomitant: RotaTeq + MCC vaccine doses 2 / sequential: MCC vaccine dose 2 alone).
    End point values
    		 Concomitant administration - visit 2 Sequential administration - visit 2 Concomitant administration - visit 4 Sequential administration - visit 4
    Number of subjects analysed
    116
    122
    115
    120
    Units: Percentage of subjects
    number (confidence interval 95%)
        Diarrhoea
    23.3 (15.9 to 32)
    14.8 (9 to 22.3)
    13 (7.5 to 20.6)
    12.5 (7.2 to 19.8)
        Vomiting
    19.8 (13 to 28.3)
    9.8 (5.2 to 16.6)
    10.4 (5.5 to 17.5)
    10 (5.3 to 16.8)
        Pyrexia
    8.6 (4.2 to 15.3)
    7.4 (3.4 to 13.5)
    18.3 (11.7 to 26.5)
    10 (5.3 to 16.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited non-serious adverse events (AEs) and all serious AEs were collected from D0 to D13 following each vaccination. Deaths and vaccine- or procedure-related serious AEs were collected throughout the study.
    Adverse event reporting additional description
    Analysis of AEs was performed on the Safety Sets, i.e. all subjects who received at least 1 of the study vaccines and who had safety follow-up data at each visit. Unsolicited non-serious systemic AEs (vaccine-related or not) with incidence ≥1% in at least 1 reporting group are presented hereafter. None of the serious AEs were vaccine-related.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Sequential administration - visit 1
    Reporting group description
    		 # Subjects who received RotaTeq dose 1 at 6-7 weeks of age (visit 1) and who had safety follow-up data at visit 1. # Respectively, 65 (53.3%) subjects reported at least 1 non-serious unsolicited systemic AE, and 56 (45.9%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE within 13 days after RotaTeq dose 1.

    Reporting group title
    Concomitant administration - visit 2
    Reporting group description
    		 # Subjects who concomitantly received RotaTeq + MCC vaccine doses 1 at 10-11 weeks of age (visit 2) and who had safety follow-up data at visit 2. # Respectively, 72 (62.1%) subjects reported at least 1 non-serious unsolicited systemic AE, 53 (45.7%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE, and 57 (49.1%) subjects reported at least 1 MCC vaccine-related non-serious unsolicited systemic AE within 13 days after RotaTeq + MCC vaccine doses 1.

    Reporting group title
    Sequential administration - visit 2
    Reporting group description
    		 # Subjects who received MCC vaccine dose 1 at 10-11 weeks of age (visit 2) and who had safety follow-up data at visit 2. # Respectively, 61 (50.0%) subjects reported at least 1 non-serious unsolicited systemic AE, and 46 (37.7%) subjects reported at least 1 MCC vaccine-related non-serious unsolicited systemic AE within 13 days after MCC vaccine dose 1.

    Reporting group title
    Sequential administration - visit 3
    Reporting group description
    		 # Subjects who received RotaTeq dose 2 at 15-16 weeks of age (visit 3) and who had safety follow-up data at visit 3. # Respectively, 46 (38.3%) subjects reported at least 1 non-serious unsolicited systemic AE, and 27 (22.5%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE within 13 days after RotaTeq dose 2.

    Reporting group title
    Concomitant administration - visit 4
    Reporting group description
    		 # Subjects who concomitantly received RotaTeq + MCC vaccine doses 2 at 20-21 weeks of age (visit 4) and who had safety follow-up data at visit 4. # Respectively, 47 (40.9%) subjects reported at least 1 non-serious unsolicited systemic AE, 28 (24.3%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE, and 29 (25.2%) subjects reported at least 1 MCC vaccine-related non-serious unsolicited systemic AE within 13 days after RotaTeq + MCC vaccine doses 2.

    Reporting group title
    Sequential administration - visit 4
    Reporting group description
    		 # Subjects who received MCC vaccine dose 2 at 20-21 weeks of age (visit 4) and who had safety follow-up data at visit 4. # Respectively, 45 (37.5%) subjects reported at least 1 non-serious unsolicited systemic AE, and 37 (30.8%) subjects reported at least 1 MCC vaccine-related non-serious unsolicited systemic AE within 13 days after MCC vaccine dose 2.

    Reporting group title
    Concomitant administration - visit 5
    Reporting group description
    		 # Subjects who received RotaTeq dose 3 at 24-25 weeks of age (visit 5) and who had safety follow-up data at visit 5. Note: these subjects previously received RotaTeq and MCC vaccine doses 1 & 2 concomitantly. # Respectively, 25 (22.9%) subjects reported at least 1 non-serious unsolicited systemic AE, and 13 (11.9%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE within 13 days after RotaTeq dose 3.

    Reporting group title
    Sequential administration - visit 5
    Reporting group description
    		 # Subjects who received RotaTeq dose 3 at 24-25 weeks of age (visit 5) and who had safety follow-up data at visit 5. Note: these subjects previously received RotaTeq and MCC vaccine doses 1 & 2 sequentially. # Respectively, 26 (22.0%) subjects reported at least 1 non-serious unsolicited systemic AE, and 15 (12.7%) subjects reported at least 1 RotaTeq-related non-serious unsolicited systemic AE within 13 days after RotaTeq dose 3.

    Serious adverse events
    		 Sequential administration - visit 1 Concomitant administration - visit 2 Sequential administration - visit 2 Sequential administration - visit 3 Concomitant administration - visit 4 Sequential administration - visit 4 Concomitant administration - visit 5 Sequential administration - visit 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    1 / 115 (0.87%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    1 / 118 (0.85%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    1 / 115 (0.87%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Sequential administration - visit 1 Concomitant administration - visit 2 Sequential administration - visit 2 Sequential administration - visit 3 Concomitant administration - visit 4 Sequential administration - visit 4 Concomitant administration - visit 5 Sequential administration - visit 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 122 (53.28%)
    72 / 116 (62.07%)
    61 / 122 (50.00%)
    46 / 120 (38.33%)
    47 / 115 (40.87%)
    45 / 120 (37.50%)
    25 / 109 (22.94%)
    26 / 118 (22.03%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    4 / 122 (3.28%)
    8 / 116 (6.90%)
    4 / 122 (3.28%)
    0 / 120 (0.00%)
    2 / 115 (1.74%)
    2 / 120 (1.67%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    4
    8
    4
    0
    2
    2
    0
    0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    13 / 122 (10.66%)
    45 / 116 (38.79%)
    30 / 122 (24.59%)
    9 / 120 (7.50%)
    21 / 115 (18.26%)
    18 / 120 (15.00%)
    5 / 109 (4.59%)
    4 / 118 (3.39%)
         occurrences all number
    13
    48
    32
    10
    22
    21
    5
    4
    Pyrexia
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 116 (1.72%)
    2 / 122 (1.64%)
    6 / 120 (5.00%)
    1 / 115 (0.87%)
    0 / 120 (0.00%)
    2 / 109 (1.83%)
    5 / 118 (4.24%)
         occurrences all number
    2
    2
    2
    6
    1
    0
    2
    5
    Fatigue
         subjects affected / exposed
    1 / 122 (0.82%)
    4 / 116 (3.45%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    1 / 115 (0.87%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    1
    4
    0
    0
    1
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 116 (0.86%)
    2 / 122 (1.64%)
    2 / 120 (1.67%)
    1 / 115 (0.87%)
    2 / 120 (1.67%)
    2 / 109 (1.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    1
    2
    2
    1
    2
    3
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    10 / 122 (8.20%)
    2 / 116 (1.72%)
    5 / 122 (4.10%)
    3 / 120 (2.50%)
    2 / 115 (1.74%)
    2 / 120 (1.67%)
    2 / 109 (1.83%)
    0 / 118 (0.00%)
         occurrences all number
    10
    3
    5
    3
    2
    3
    2
    0
    Constipation
         subjects affected / exposed
    4 / 122 (3.28%)
    1 / 116 (0.86%)
    2 / 122 (1.64%)
    0 / 120 (0.00%)
    0 / 115 (0.00%)
    1 / 120 (0.83%)
    2 / 109 (1.83%)
    0 / 118 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    16 / 122 (13.11%)
    0 / 116 (0.00%)
    2 / 122 (1.64%)
    10 / 120 (8.33%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    7 / 109 (6.42%)
    7 / 118 (5.93%)
         occurrences all number
    19
    0
    2
    11
    0
    0
    7
    7
    Faeces discoloured
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 116 (1.72%)
    0 / 122 (0.00%)
    1 / 120 (0.83%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    16 / 122 (13.11%)
    6 / 116 (5.17%)
    1 / 122 (0.82%)
    5 / 120 (4.17%)
    4 / 115 (3.48%)
    1 / 120 (0.83%)
    0 / 109 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    16
    7
    1
    5
    4
    1
    0
    3
    Regurgitation of food
         subjects affected / exposed
    9 / 122 (7.38%)
    5 / 116 (4.31%)
    1 / 122 (0.82%)
    3 / 120 (2.50%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    2 / 109 (1.83%)
    2 / 118 (1.69%)
         occurrences all number
    9
    5
    1
    3
    0
    0
    2
    2
    Vomiting
         subjects affected / exposed
    7 / 122 (5.74%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    4 / 120 (3.33%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    1 / 109 (0.92%)
    2 / 118 (1.69%)
         occurrences all number
    8
    0
    0
    5
    0
    0
    1
    2
    Teething
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    6 / 115 (5.22%)
    0 / 120 (0.00%)
    2 / 109 (1.83%)
    3 / 118 (2.54%)
         occurrences all number
    0
    0
    0
    0
    6
    0
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 116 (0.86%)
    1 / 122 (0.82%)
    1 / 120 (0.83%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 122 (0.00%)
    6 / 116 (5.17%)
    2 / 122 (1.64%)
    1 / 120 (0.83%)
    0 / 115 (0.00%)
    1 / 120 (0.83%)
    0 / 109 (0.00%)
    4 / 118 (3.39%)
         occurrences all number
    0
    6
    2
    1
    0
    1
    0
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 116 (1.72%)
    1 / 122 (0.82%)
    2 / 120 (1.67%)
    3 / 115 (2.61%)
    5 / 120 (4.17%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    2
    2
    1
    2
    3
    5
    0
    0
    Erythema
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    2 / 122 (1.64%)
    0 / 120 (0.00%)
    0 / 115 (0.00%)
    1 / 120 (0.83%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 116 (0.86%)
    1 / 122 (0.82%)
    2 / 120 (1.67%)
    1 / 115 (0.87%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    1
    1
    1
    2
    1
    0
    0
    0
    Psychiatric disorders
    Crying
         subjects affected / exposed
    6 / 122 (4.92%)
    6 / 116 (5.17%)
    11 / 122 (9.02%)
    2 / 120 (1.67%)
    6 / 115 (5.22%)
    11 / 120 (9.17%)
    2 / 109 (1.83%)
    0 / 118 (0.00%)
         occurrences all number
    6
    7
    12
    2
    6
    11
    3
    0
    Restlessness
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 116 (0.86%)
    2 / 122 (1.64%)
    0 / 120 (0.00%)
    0 / 115 (0.00%)
    2 / 120 (1.67%)
    0 / 109 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    1
    2
    0
    0
    2
    0
    2
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    8 / 122 (6.56%)
    5 / 116 (4.31%)
    7 / 122 (5.74%)
    6 / 120 (5.00%)
    3 / 115 (2.61%)
    2 / 120 (1.67%)
    5 / 109 (4.59%)
    3 / 118 (2.54%)
         occurrences all number
    8
    6
    7
    6
    3
    2
    5
    3
    Respiratory tract infection
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 116 (1.72%)
    0 / 122 (0.00%)
    1 / 120 (0.83%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    1 / 109 (0.92%)
    1 / 118 (0.85%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 116 (2.59%)
    4 / 122 (3.28%)
    5 / 120 (4.17%)
    1 / 115 (0.87%)
    2 / 120 (1.67%)
    1 / 109 (0.92%)
    0 / 118 (0.00%)
         occurrences all number
    1
    3
    4
    5
    1
    2
    1
    0
    Varicella
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 116 (0.00%)
    0 / 122 (0.00%)
    2 / 120 (1.67%)
    0 / 115 (0.00%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 116 (0.86%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    3 / 115 (2.61%)
    0 / 120 (0.00%)
    0 / 109 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    1
    0
    0
    3
    0
    0
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 116 (2.59%)
    0 / 122 (0.00%)
    0 / 120 (0.00%)
    2 / 115 (1.74%)
    2 / 120 (1.67%)
    0 / 109 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    1
    4
    0
    0
    2
    2
    0
    1

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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.
    None reported
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    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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