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    Clinical Trial Results:
    A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants

    Summary
    EudraCT number
    		 2020-003329-49
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 May 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Apr 2023
    First version publication date
    21 Jan 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-074
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04481191
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.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
    08 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 2020
    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
    China: 400
    Worldwide total number of subjects
    400
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    400
    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
    		 -

    Pre-assignment
    Screening details
    		 Healthy Chinese infants age 48-63 days were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Concomitant RotaTeq and IPV
    Arm description
    		 Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    IPV
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose IPV (Sabin strain based), administered via IM injection.

    Investigational medicinal product name
    RotaTeq
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution.

    Arm title
    		 Staggered RotaTeq and IPV
    Arm description
    		 Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Inactivated Poliomyelitis Vaccine
    Investigational medicinal product code
    Other name
    IPV
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose IPV (Sabin strain based), administered via IM injection.

    Investigational medicinal product name
    RotaTeq
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution.

    Number of subjects in period 1
    		Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Started
    200
    200
    ≥1 V260 Vaccination
    189
    200
    Completed
    185
    190
    Not completed
    15
    10
         Withdrawn by parent/guardian
    15
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concomitant RotaTeq and IPV
    Reporting group description
    		 Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Reporting group title
    Staggered RotaTeq and IPV
    Reporting group description
    		 Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Reporting group values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV Total
    Number of subjects
    		 200 200 400
    Age categorical
    Units: Subjects
        Infants and toddlers (48 days - 63 days)
    		 200 200 400
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 53.3 ± 4.8 53.3 ± 4.6 -
    Gender categorical
    Units: Subjects
        Female
    		 86 93 179
        Male
    		 114 107 221
    Race
    Units: Subjects
        Asian
    		 200 200 400

    End points

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    End points reporting groups
    Reporting group title
    Concomitant RotaTeq and IPV
    Reporting group description
    		 Participants received RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Reporting group title
    Staggered RotaTeq and IPV
    Reporting group description
    		 Participants received RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Primary: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV

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    End point title
    		 Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
    End point description
    The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants. Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.
    End point type
    Primary
    End point timeframe
    Baseline and 1 month postdose 3 of IPV (Month ~3.5)
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    180
    187
    Units: Percentage of Participants
    number (not applicable)
        Poliovirus Type 1
    98.9
    100.0
        Poliovirus Type 2
    98.3
    99.5
        Poliovirus Type 3
    100.0
    99.5
    Statistical analysis title
    		 Poliovirus Type 1 Group Difference
    Statistical analysis description
    Difference indicates Concomitant-use Group % - Staggered-use Group %
    Comparison groups
    Staggered RotaTeq and IPV v Concomitant RotaTeq and IPV
    Number of subjects included in analysis
    367
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Unstratified Miettinen & Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 0.9
    Notes
    [1] - Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being > -10 percentage points (one-sided p-value < 0.025).
    [2] - One-sided p-value
    Statistical analysis title
    		 Poliovirus Type 3 Group Difference
    Statistical analysis description
    Difference indicates Concomitant-use % - Staggered-use %
    Comparison groups
    Concomitant RotaTeq and IPV v Staggered RotaTeq and IPV
    Number of subjects included in analysis
    367
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 Unstratified Miettinen & Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 3
    Notes
    [3] - Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being > -10 percentage points (one-sided p-value < 0.025).
    [4] - One-sided p-value
    Statistical analysis title
    		 Poliovirus Type 2 Group Difference
    Statistical analysis description
    Difference indicates Concomitant-use Group % - Staggered-use Group %
    Comparison groups
    Concomitant RotaTeq and IPV v Staggered RotaTeq and IPV
    Number of subjects included in analysis
    367
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 Unstratified Miettinen & Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 1.5
    Notes
    [5] - Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being > -10 percentage points (one-sided p-value < 0.025).
    [6] - One-sided p-value

    Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
    End point description
    The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.
    End point type
    Secondary
    End point timeframe
    1 month postdose 3 of IPV (Month ~3.5)
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    180
    187
    Units: Titers
    geometric mean (confidence interval 95%)
        Poliovirus Type 1
    5600.80 (4898.46 to 6403.85)
    5344.24 (4657.51 to 6132.22)
        Poliovirus Type 2
    1059.83 (951.13 to 1180.96)
    1122.43 (1002.74 to 1256.41)
        Poliovirus Type 3
    3405.56 (3033.93 to 3822.71)
    3261.69 (2913.70 to 3651.24)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV

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    End point title
    		 Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
    End point description
    The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.
    End point type
    Secondary
    End point timeframe
    1 month post dose 3 of IPV (Month ~3.5)
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    180
    187
    Units: Percentage of Participants
    number (confidence interval 95%)
        Poliovirus Type 1
    100.0 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
        Poliovirus Type 2
    100.0 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
        Poliovirus Type 3
    100.0 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV

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    End point title
    		 Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
    End point description
    The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.
    End point type
    Secondary
    End point timeframe
    1 month postdose 3 of IPV (Month ~3.5)
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    180
    187
    Units: Percentage of Participants
    number (confidence interval 95%)
        Poliovirus Type 1
    100.00 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
        Poliovirus Type 2
    100.0 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
        Poliovirus Type 3
    100.0 (98.0 to 100.0)
    100.0 (98.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-Site Adverse Events

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    End point title
    		 Percentage of Participants With Solicited Injection-Site Adverse Events
    End point description
    Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site. All participants who received ≥1 dose of study treatment are included.
    End point type
    Secondary
    End point timeframe
    Up to 7 days following each IPV vaccination
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    189
    200
    Units: Percentage of Participants
        number (not applicable)
    25.4
    23.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Systemic Adverse Events

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    End point title
    		 Percentage of Participants With Solicited Systemic Adverse Events
    End point description
    Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C). All participants who received ≥1 dose of study treatment are included.
    End point type
    Secondary
    End point timeframe
    Up to 7 days following each RotaTeq and/or IPV vaccination
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    189
    200
    Units: Percentage of Participants
    number (not applicable)
        Elevated temperature
    12.3
    16.3
        Diarrhoea
    13.2
    21.5
        Vomiting
    10.6
    19.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Serious Adverse Events (SAEs)
    End point description
    The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event. All participants who received ≥1 dose of study treatment are included.
    End point type
    Secondary
    End point timeframe
    Up to approximately 3.5 months
    End point values
    		 Concomitant RotaTeq and IPV Staggered RotaTeq and IPV
    Number of subjects analysed
    189
    200
    Units: Percentage of Participants
        number (not applicable)
    3.7
    5.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 3.5 months
    Adverse event reporting additional description
    All participants who received ≥1 study-related vaccination are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Staggered RotaTeq and IPV
    Reporting group description
    		 Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Reporting group title
    Concomitant RotaTeq and IPV
    Reporting group description
    		 Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

    Serious adverse events
    		 Staggered RotaTeq and IPV Concomitant RotaTeq and IPV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 200 (5.50%)
    7 / 189 (3.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Motor developmental delay
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Laryngeal obstruction
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 200 (0.00%)
    3 / 189 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 200 (3.00%)
    3 / 189 (1.59%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Staggered RotaTeq and IPV Concomitant RotaTeq and IPV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    143 / 200 (71.50%)
    123 / 189 (65.08%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    41 / 200 (20.50%)
    45 / 189 (23.81%)
         occurrences all number
    45
    62
    Injection site pain
         subjects affected / exposed
    7 / 200 (3.50%)
    12 / 189 (6.35%)
         occurrences all number
    7
    14
    Pyrexia
         subjects affected / exposed
    37 / 200 (18.50%)
    30 / 189 (15.87%)
         occurrences all number
    48
    33
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    50 / 200 (25.00%)
    33 / 189 (17.46%)
         occurrences all number
    77
    43
    Dyspepsia
         subjects affected / exposed
    13 / 200 (6.50%)
    10 / 189 (5.29%)
         occurrences all number
    14
    13
    Vomiting
         subjects affected / exposed
    39 / 200 (19.50%)
    20 / 189 (10.58%)
         occurrences all number
    66
    23
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 200 (7.00%)
    19 / 189 (10.05%)
         occurrences all number
    16
    26
    Rhinorrhoea
         subjects affected / exposed
    18 / 200 (9.00%)
    17 / 189 (8.99%)
         occurrences all number
    20
    18
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    12 / 200 (6.00%)
    14 / 189 (7.41%)
         occurrences all number
    18
    14
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    36 / 200 (18.00%)
    31 / 189 (16.40%)
         occurrences all number
    41
    40
    Bronchitis
         subjects affected / exposed
    13 / 200 (6.50%)
    8 / 189 (4.23%)
         occurrences all number
    14
    9
    Nasopharyngitis
         subjects affected / exposed
    14 / 200 (7.00%)
    14 / 189 (7.41%)
         occurrences all number
    16
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2020
    Amendment 01: The primary purpose was to align protocol with new guideline on the grading scales for adverse events in vaccine studies in China.
    11 Aug 2020
    Amendment 2: The primary purpose was to add the EudraCT number and clarify baseline characteristics to be collected.

    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.
    Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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