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    Clinical Trial Results:
    A Randomized, Double-Blind Trial to Assess the Safety and Relative Efficacy of CAIV-T Against Inactivated Influenza Vaccine in Children 6–59 Months of Age

    Summary
    EudraCT number
    		 2004-000585-13
    Trial protocol
    		 FI   SE   CZ   ES   IS   GB   IT   BE  
    Global end of trial date
    31 Aug 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2016
    First version publication date
    06 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP111
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00128167
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Dr. Raburn Mallory, MedImmune, LLC, +1 301-398-4862,
    Scientific contact
    Dr. Raburn Mallory, MedImmune, LLC, +1 301-398-4862,
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Aug 2005
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV. It also included to estimate the relative effectiveness of CAIV-T compared to TIV, and to assess the tolerability of CAIV-T compared to TIV.
    Protection of trial subjects
    Safety evaluations included adverse events (AEs), serious adverse events (SAEs),concomitant medication use and Reactogenicity event (REs) (which were a subset of solicited events),Significant new medical condition (SNMCs) were also collected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2004
    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
    United States: 4117
    Country: Number of subjects enrolled
    Finland: 725
    Country: Number of subjects enrolled
    Israel: 653
    Country: Number of subjects enrolled
    United Kingdom: 563
    Country: Number of subjects enrolled
    Belgium: 459
    Country: Number of subjects enrolled
    Italy: 316
    Country: Number of subjects enrolled
    Spain: 238
    Country: Number of subjects enrolled
    Czech Republic: 139
    Country: Number of subjects enrolled
    Germany: 109
    Country: Number of subjects enrolled
    Iceland: 50
    Country: Number of subjects enrolled
    Hong Kong: 255
    Country: Number of subjects enrolled
    Taiwan: 178
    Country: Number of subjects enrolled
    Korea, Republic of: 109
    Country: Number of subjects enrolled
    Lebanon: 216
    Country: Number of subjects enrolled
    Sweden: 190
    Country: Number of subjects enrolled
    Greece: 158
    Worldwide total number of subjects
    8475
    EEA total number of subjects
    2947
    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)
    4024
    Children (2-11 years)
    4451
    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
    		 The trial was conducted at 249 sites: 133 sites in the United States, 15 sites in Asia, and 101 sites in Europe/ Middle East. The study was conducted between 20/Oct/04 and 31/Aug/05.

    Pre-assignment
    Screening details
    		 A total of 8500 participants were screened; 8475 participants were randomized into the study: 4243 in the CAIV-T group, and 4232 in the TIV group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intranasal CAIV-T plus intramuscular placebo
    Arm description
    		 Participants who were previously vaccinated with an influenza vaccine received CAIV-T 0.2 milliliter (mL) once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received CAIV-T 0.2 mL twice as intranasal spray, Dose 1 on Day 0 and dose 2 on Day 28-42 after dose 1. Placebo matching with TIV administered as intramuscular injection along with CAIV-T. CAIV-T contains approximately 10^7 fluorescent focus units (FFU) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cold-Adapted Influenza Virus Vaccine - Trivalent Liquid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A total volume of 0.2 mL containing approximately 10t^7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the influenza strains.

    Arm title
    		 Intramuscular TIV plus intranasal placebo
    Arm description
    		 Participants who were previously vaccinated with an influenza vaccine received TIV 0.25 or 0.5 mL once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received TIV 0.25 or 0.5 mL twice as intranasal spray, Dose 1 on Day 0 and Dose 2 on Day 28-42 after dose 1. Placebo matching with CAIV-T administered as intramuscular injection along with TIV. Participant with age of 6-35 months received 0.25 mL and participants with age 36-59 months received 0.5mL of TIV. TIV contains 45 micrograms of Hemagglutinin (HA) per 0.5 mL, in the recommended ratio of 15 micrograms of HA for each of the three influenza strains.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaxigrip
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    A total volume of 0.2 mL containing approximately 10t^7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the influenza strains.

    Number of subjects in period 1
    		Intranasal CAIV-T plus intramuscular placebo Intramuscular TIV plus intranasal placebo
    Started
    4243
    4232
    Completed
    3933
    3911
    Not completed
    310
    321
         Consent withdrawn by subject
    116
    118
         Parent/guardian non-compliance
    -
    1
         Subject expired prior to Day 180
    1
    1
         Failed to contact subject’s guardian
    3
    2
         Subject moved out of area
    2
    3
         Terminated before Day 180 or 31/05/05
    10
    17
         Subject randomized but never dosed
    10
    6
         Lost to follow-up
    168
    173

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intranasal CAIV-T plus intramuscular placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received CAIV-T 0.2 milliliter (mL) once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received CAIV-T 0.2 mL twice as intranasal spray, Dose 1 on Day 0 and dose 2 on Day 28-42 after dose 1. Placebo matching with TIV administered as intramuscular injection along with CAIV-T. CAIV-T contains approximately 10^7 fluorescent focus units (FFU) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens.

    Reporting group title
    Intramuscular TIV plus intranasal placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received TIV 0.25 or 0.5 mL once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received TIV 0.25 or 0.5 mL twice as intranasal spray, Dose 1 on Day 0 and Dose 2 on Day 28-42 after dose 1. Placebo matching with CAIV-T administered as intramuscular injection along with TIV. Participant with age of 6-35 months received 0.25 mL and participants with age 36-59 months received 0.5mL of TIV. TIV contains 45 micrograms of Hemagglutinin (HA) per 0.5 mL, in the recommended ratio of 15 micrograms of HA for each of the three influenza strains.

    Reporting group values
    		 Intranasal CAIV-T plus intramuscular placebo Intramuscular TIV plus intranasal placebo Total
    Number of subjects
    		 4243 4232 8475
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous |
    Units: months
        arithmetic mean (standard deviation)
    		 25.7 ( 13.4 ) 25.6 ( 13.2 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 2065 2055 4120
        Male
    		 2178 2177 4355

    End points

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    End points reporting groups
    Reporting group title
    Intranasal CAIV-T plus intramuscular placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received CAIV-T 0.2 milliliter (mL) once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received CAIV-T 0.2 mL twice as intranasal spray, Dose 1 on Day 0 and dose 2 on Day 28-42 after dose 1. Placebo matching with TIV administered as intramuscular injection along with CAIV-T. CAIV-T contains approximately 10^7 fluorescent focus units (FFU) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens.

    Reporting group title
    Intramuscular TIV plus intranasal placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received TIV 0.25 or 0.5 mL once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received TIV 0.25 or 0.5 mL twice as intranasal spray, Dose 1 on Day 0 and Dose 2 on Day 28-42 after dose 1. Placebo matching with CAIV-T administered as intramuscular injection along with TIV. Participant with age of 6-35 months received 0.25 mL and participants with age 36-59 months received 0.5mL of TIV. TIV contains 45 micrograms of Hemagglutinin (HA) per 0.5 mL, in the recommended ratio of 15 micrograms of HA for each of the three influenza strains.

    Subject analysis set title
    One Dose Group (CAIV-T)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive a single dose of study vaccine plus corresponding placebo (Dose One) on Study Day 0.

    Subject analysis set title
    One Dose Group (TIV)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive a single dose of study vaccine plus corresponding placebo (Dose One) on Study Day 0.

    Subject analysis set title
    Two dose Group (CAIV-T) - After Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two Dose Group (TIV) - After Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two dose Group (CAIV-T) - After Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two dose Group (TIV) - After Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    One Dose Group (CAIV-T)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive a single dose of study vaccine plus corresponding placebo (Dose One) on Study Day 0.

    Subject analysis set title
    One Dose Group (TIV)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive a single dose of study vaccine plus corresponding placebo (Dose One) on Study Day 0.

    Subject analysis set title
    Two dose Group (CAIV-T) - After Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two Dose Group (TIV) - After Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two dose Group (CAIV-T) - After Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Subject analysis set title
    Two dose Group (TIV) - After Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) were to receive two doses of study vaccine plus corresponding placebo: Dose One on Study Day 0 and Dose Two 28-42 days after the first dose.

    Primary: Number of Participants With Culture-Confirmed Modified Influenza-Like-Illness per the Centers for Disease Control (CDC-ILI) Caused by Wild-Type Strains

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    End point title
    		 Number of Participants With Culture-Confirmed Modified Influenza-Like-Illness per the Centers for Disease Control (CDC-ILI) Caused by Wild-Type Strains
    End point description
    The CDC-ILI (CDC-defined influenza-like illness), defined as fever (temperature >=100°F oral or equivalent) plus cough or sore throat on the same or consecutive days, was modified (“modified CDC-ILI”) to fever plus cough, sore throat, or runny nose/nasal congestion as a means of capturing age-appropriate influenza illness symptoms. Modified CDC-ILI was defined as a positive culture for a wild-type influenza virus associated within >=7 days of modified CDC-ILI symptoms.
    End point type
    Primary
    End point timeframe
    14 days after last dose of study vaccination
    End point values
    		 Intranasal CAIV-T plus intramuscular placebo Intramuscular TIV plus intranasal placebo
    Number of subjects analysed
    4243
    4232
    Units: participants
        Antigenically Similar: All strains
    53
    93
        Antigenically Dissimilar: All strains
    102
    245
        Regardless of Antigenic Match: All strains
    153
    338
    Statistical analysis title
    		 Relative efficacy - Antigenically Similar
    Statistical analysis description
    Antigenically Similar: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intramuscular TIV plus intranasal placebo v Intranasal CAIV-T plus intramuscular placebo
    Number of subjects included in analysis
    8475
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    44.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.4
         upper limit
    		 60.6
    Statistical analysis title
    		 Relative Efficacy - Antigenically Dissimilar
    Statistical analysis description
    Antigenically Dissimilar: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intranasal CAIV-T plus intramuscular placebo v Intramuscular TIV plus intranasal placebo
    Number of subjects included in analysis
    8475
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    58.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47
         upper limit
    		 67
    Statistical analysis title
    		 Relative efficacy - Regardless of Antigenic Match
    Statistical analysis description
    Regardless of Antigenic Match: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intranasal CAIV-T plus intramuscular placebo v Intramuscular TIV plus intranasal placebo
    Number of subjects included in analysis
    8475
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    54.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 45.4
         upper limit
    		 62.9

    Secondary: Number of Participants With Culture-confirmed Symptomatic Influenza Infection Caused by Wild-type Strains

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    End point title
    		 Number of Participants With Culture-confirmed Symptomatic Influenza Infection Caused by Wild-type Strains
    End point description
    Culture-confirmed symptomatic influenza infection was defined as a positive culture for a community-acquired wild-type influenza virus associated within 7 days with one (or more) of the qualifying illness symptoms: fever (temperature 99.8°F oral or equivalent), wheezing, shortness of breath, pulmonary congestion (including bronchitis, bronchiolitis, and croup), pneumonia, or ear infection (acute otitis media, suspected or diagnosed); OR at least two of the following symptoms concurrently: runny/stuffy nose (rhinorrhea), sore throat (pharyngitis), cough, muscle aches, chills, headache, irritability, decreased activity, or vomiting.
    End point type
    Secondary
    End point timeframe
    14 days after last dose of study vaccination
    End point values
    		 Intranasal CAIV-T plus intramuscular placebo Intramuscular TIV plus intranasal placebo
    Number of subjects analysed
    3916
    3936
    Units: participants
        Antigenically Similar: All strains
    22
    33
        Antigenically Dissimilar: All strains
    31
    98
        Regardless of Antigenic Match: All strains
    0
    0
    Statistical analysis title
    		 Relative efficacy - Antigenically Similar
    Statistical analysis description
    Antigenically Similar: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intranasal CAIV-T plus intramuscular placebo v Intramuscular TIV plus intranasal placebo
    Number of subjects included in analysis
    7852
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    34.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 62.4
    Statistical analysis title
    		 Relative efficacy - Antigenically Dissimilar
    Statistical analysis description
    Antigenically Dissimilar: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intranasal CAIV-T plus intramuscular placebo v Intramuscular TIV plus intranasal placebo
    Number of subjects included in analysis
    7852
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    68.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.1
         upper limit
    		 79.2
    Statistical analysis title
    		 Relative efficacy - Regardless of Antigenic Match
    Statistical analysis description
    Regardless of Antigenic Match: All strains - relative efficacy was adjusted for country, age, prior vaccination status, and wheezing history status.
    Comparison groups
    Intranasal CAIV-T plus intramuscular placebo v Intramuscular TIV plus intranasal placebo
    Number of subjects included in analysis
    7852
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Relative efficacy
    Point estimate
    62.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48.1
         upper limit
    		 73

    Secondary: Number of Participants With Reactogenicity Events

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    End point title
    		 Number of Participants With Reactogenicity Events
    End point description
    Reactogenicity events included Runny/stuffy nose. sore throat, cough, vomiting, headache, muscle ache, chills, decreased activity, irritability, abdominal pain, decreased appetite and fever 100 - 104 degree Fahrenheit.
    End point type
    Secondary
    End point timeframe
    Day 0 to 10
    End point values
    		 One Dose Group (CAIV-T) One Dose Group (TIV) Two dose Group (CAIV-T) - After Dose 1 Two Dose Group (TIV) - After Dose 1 Two dose Group (CAIV-T) - After Dose 2 Two dose Group (TIV) - After Dose 2
    Number of subjects analysed
    933
    947
    3246
    3226
    3002
    3034
    Units: Participants
    641
    597
    2232
    1998
    1633
    1537
    No statistical analyses for this end point

    Secondary: Number of Participants With Injection Site Reactions

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    End point title
    		 Number of Participants With Injection Site Reactions
    End point description
    Injection site reactions included injection site pain, injection site redness and injection site swelling.
    End point type
    Secondary
    End point timeframe
    Day 0 to 10
    End point values
    		 One Dose Group (CAIV-T) One Dose Group (TIV) Two dose Group (CAIV-T) - After Dose 1 Two Dose Group (TIV) - After Dose 1 Two dose Group (CAIV-T) - After Dose 2 Two dose Group (TIV) - After Dose 2
    Number of subjects analysed
    929
    935
    3205
    3179
    2997
    3001
    Units: Participants
    266
    340
    677
    788
    439
    596
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 180 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
    End point type
    Secondary
    End point timeframe
    Day 0 to 180
    End point values
    		 One Dose Group (CAIV-T) One Dose Group (TIV) Two dose Group (CAIV-T) - After Dose 1 Two Dose Group (TIV) - After Dose 1 Two dose Group (CAIV-T) - After Dose 2 Two dose Group (TIV) - After Dose 2
    Number of subjects analysed
    933
    947
    3246
    3226
    3002
    3034
    Units: Participants
        TEAEs
    311
    301
    1105
    1109
    813
    824
        TESAEs
    3
    7
    22
    16
    22
    25
    No statistical analyses for this end point

    Secondary: Number of Participants with Medically Significant Wheezing

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    End point title
    		 Number of Participants with Medically Significant Wheezing
    End point description
    Post hoc analyses were performed to evaluate whether subjects who experienced medically significant wheezing were more likely to be subsequently diagnosed with a new condition of asthma, bronchospasm, or wheezing.
    End point type
    Secondary
    End point timeframe
    Upto 42 days post last dose
    End point values
    		 Intranasal CAIV-T plus intramuscular placebo Intramuscular TIV plus intranasal placebo
    Number of subjects analysed
    4179
    4173
    Units: Participants
        Participants: Medically Significant Wheezing
    164
    131
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to 180 post last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Intranasal CAIV-T plus intramuscular placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received CAIV-T 0.2 milliliter (mL) once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received CAIV-T 0.2 mL twice as intranasal spray, Dose one on Day 0 and dose 2 on Day 28-42 days after dose 1. Placebo matching with TIV administered as intramuscular injection along with CAIV-T. CAIV-T contains g approximately 10^7 fluorescent focus units (FFU) of each of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the following influenza strains.

    Reporting group title
    TOTAL
    Reporting group description
    		 -

    Reporting group title
    Intramuscular TIV plus intranasal placebo
    Reporting group description
    		 Participants who were previously vaccinated with an influenza vaccine received TIV 0.25 or 0.5 mL once on Day 0 as intranasal spray. Participants who were not vaccinated with and influenza vaccine received TIV 0.25 or 0.5 mL twice as intranasal spray, Dose one on Day 0 and Dose 2 on Day 28-42 days after dose 1. Placebo matching with CAIV-T administered as intramuscular injection along with TIV. Participant with age of 6-35 months received 0.25 mL and participants with age 6-35 mL received 0.5mL of TIV. TIV contains 45 micrograms of Hemagglutinin (HA) per 0.5 mL, in the recommended ratio of 15 micrograms of HA for each of the three influenza strains.

    Serious adverse events
    		 Intranasal CAIV-T plus intramuscular placebo TOTAL Intramuscular TIV plus intranasal placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    140 / 4179 (3.35%)
    272 / 8351 (3.26%)
    132 / 4172 (3.16%)
         number of deaths (all causes)
    2
    2
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myeloid leukaemia
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroblastoma
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Blood stem cell harvest
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Catheter related complication
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal disorder
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    3 / 4179 (0.07%)
    6 / 8351 (0.07%)
    3 / 4172 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    3 / 4179 (0.07%)
    4 / 8351 (0.05%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    3 / 4179 (0.07%)
    5 / 8351 (0.06%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    White blood cell count increased
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental exposure
         subjects affected / exposed
    0 / 4179 (0.00%)
    3 / 8351 (0.04%)
    3 / 4172 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone fissure
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 4179 (0.02%)
    3 / 8351 (0.04%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 4179 (0.00%)
    2 / 8351 (0.02%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 4179 (0.02%)
    3 / 8351 (0.04%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury asphyxiation
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    3 / 4179 (0.07%)
    4 / 8351 (0.05%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrioventricular septal defect
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Autism
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    3 / 4179 (0.07%)
    3 / 8351 (0.04%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    5 / 4179 (0.12%)
    14 / 8351 (0.17%)
    9 / 4172 (0.22%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 15
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic epilepsy
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 4179 (0.05%)
    2 / 8351 (0.02%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 4179 (0.00%)
    3 / 8351 (0.04%)
    3 / 4172 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 4179 (0.07%)
    4 / 8351 (0.05%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Henoch-schonlein purpura
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria generalised
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 4179 (0.00%)
    2 / 8351 (0.02%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    7 / 4179 (0.17%)
    13 / 8351 (0.16%)
    6 / 4172 (0.14%)
         occurrences causally related to treatment / all
    2 / 7
    2 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 4179 (0.12%)
    5 / 8351 (0.06%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 4179 (0.02%)
    6 / 8351 (0.07%)
    5 / 4172 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    21 / 4179 (0.50%)
    44 / 8351 (0.53%)
    23 / 4172 (0.55%)
         occurrences causally related to treatment / all
    1 / 22
    1 / 45
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    5 / 4179 (0.12%)
    12 / 8351 (0.14%)
    7 / 4172 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 4179 (0.07%)
    5 / 8351 (0.06%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpetic gingivostomatitis
         subjects affected / exposed
    3 / 4179 (0.07%)
    4 / 8351 (0.05%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpetic stomatitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    3 / 8351 (0.04%)
    2 / 4172 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymph node abscess
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 4179 (0.05%)
    2 / 8351 (0.02%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    3 / 4179 (0.07%)
    6 / 8351 (0.07%)
    3 / 4172 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    3 / 4179 (0.07%)
    4 / 8351 (0.05%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 4179 (0.05%)
    2 / 8351 (0.02%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    31 / 4179 (0.74%)
    57 / 8351 (0.68%)
    26 / 4172 (0.62%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 60
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 4179 (0.07%)
    3 / 8351 (0.04%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 4179 (0.14%)
    14 / 8351 (0.17%)
    8 / 4172 (0.19%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 4179 (0.02%)
    2 / 8351 (0.02%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 4179 (0.05%)
    3 / 8351 (0.04%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 4179 (0.00%)
    1 / 8351 (0.01%)
    1 / 4172 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 4179 (0.02%)
    5 / 8351 (0.06%)
    4 / 4172 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 4179 (0.02%)
    1 / 8351 (0.01%)
    0 / 4172 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Intranasal CAIV-T plus intramuscular placebo TOTAL Intramuscular TIV plus intranasal placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2708 / 4179 (64.80%)
    5372 / 8351 (64.33%)
    2664 / 4172 (63.85%)
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    40 / 4179 (0.96%)
    80 / 8351 (0.96%)
    40 / 4172 (0.96%)
         occurrences all number
    42
    84
    42
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    146 / 4179 (3.49%)
    306 / 8351 (3.66%)
    160 / 4172 (3.84%)
         occurrences all number
    156
    326
    170
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    464 / 4179 (11.10%)
    937 / 8351 (11.22%)
    473 / 4172 (11.34%)
         occurrences all number
    610
    1236
    626
    Teething
         subjects affected / exposed
    238 / 4179 (5.70%)
    493 / 8351 (5.90%)
    255 / 4172 (6.11%)
         occurrences all number
    355
    732
    377
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    65 / 4179 (1.56%)
    123 / 8351 (1.47%)
    58 / 4172 (1.39%)
         occurrences all number
    74
    145
    71
    Dyspnoea
         subjects affected / exposed
    81 / 4179 (1.94%)
    171 / 8351 (2.05%)
    90 / 4172 (2.16%)
         occurrences all number
    100
    218
    118
    Pulmonary congestion
         subjects affected / exposed
    105 / 4179 (2.51%)
    199 / 8351 (2.38%)
    94 / 4172 (2.25%)
         occurrences all number
    142
    256
    114
    Sneezing
         subjects affected / exposed
    52 / 4179 (1.24%)
    96 / 8351 (1.15%)
    44 / 4172 (1.05%)
         occurrences all number
    77
    135
    58
    Wheezing
         subjects affected / exposed
    463 / 4179 (11.08%)
    898 / 8351 (10.75%)
    435 / 4172 (10.43%)
         occurrences all number
    657
    1295
    638
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    62 / 4179 (1.48%)
    130 / 8351 (1.56%)
    68 / 4172 (1.63%)
         occurrences all number
    78
    161
    83
    Rash
         subjects affected / exposed
    97 / 4179 (2.32%)
    234 / 8351 (2.80%)
    137 / 4172 (3.28%)
         occurrences all number
    106
    254
    148
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    115 / 4179 (2.75%)
    231 / 8351 (2.77%)
    116 / 4172 (2.78%)
         occurrences all number
    135
    265
    130
    Croup infectious
         subjects affected / exposed
    221 / 4179 (5.29%)
    442 / 8351 (5.29%)
    221 / 4172 (5.30%)
         occurrences all number
    261
    521
    260
    Bronchitis
         subjects affected / exposed
    369 / 4179 (8.83%)
    721 / 8351 (8.63%)
    352 / 4172 (8.44%)
         occurrences all number
    447
    875
    428
    Gastroenteritis
         subjects affected / exposed
    74 / 4179 (1.77%)
    147 / 8351 (1.76%)
    73 / 4172 (1.75%)
         occurrences all number
    76
    150
    74
    Otitis media acute
         subjects affected / exposed
    1431 / 4179 (34.24%)
    2858 / 8351 (34.22%)
    1427 / 4172 (34.20%)
         occurrences all number
    2316
    4709
    2393
    Pharyngitis
         subjects affected / exposed
    36 / 4179 (0.86%)
    81 / 8351 (0.97%)
    45 / 4172 (1.08%)
         occurrences all number
    37
    83
    46
    Sinusitis
         subjects affected / exposed
    69 / 4179 (1.65%)
    128 / 8351 (1.53%)
    59 / 4172 (1.41%)
         occurrences all number
    74
    137
    63
    Pneumonia
         subjects affected / exposed
    131 / 4179 (3.13%)
    267 / 8351 (3.20%)
    136 / 4172 (3.26%)
         occurrences all number
    138
    285
    147

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jun 2004
    Similarily Version 2.0 of the protocol was amended to Version 3.0. The major changes included: increased sample size and corresponding power calculations; clarified the upper age limit for eligibility; clarified criteria for temperature recording; added conditions for dose administration; indicated that study vaccine blinding, supplies, and dispensing at Asian sites would be similar to those of U.S. sites, and that a dedicated SPA would be used in the U.S. and Asia for consistency with European/Middle Eastern countries (where dedicated SPAs were already in use due to the unavailability of blinded study vaccine at these sites); added more details on primary end points and definition of Local respiratory infection (LRI); Revised the evaluation of the confidence intervals, non-inferiority prior to superiority, consistency with the principles of “closed tests.”
    23 Jul 2004
    In study MI-CP111, Version 1.0 of the protocol was amended to Version 2.0 which included the following changes: increase in number of sites needed for subject recruitment and excluded children with a history of severe asthma.

    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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