Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Open-Label, Uncontrolled, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged ≥ 29 Weeks Gestational Age to < 18 Years

    Summary
    EudraCT number
    		 2021-006056-13
    Trial protocol
    		 DE   BE  
    Global end of trial date
    16 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2024
    First version publication date
    24 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D8850C00006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05281601
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85 Södertälje, Södertälje, Sweden, 15185
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003079-PIP01-22 EMEA-029000-PIP01-20 EMEA-002925-PIP01-20
    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
    21 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the serum concentrations, safety and tolerability of AZD7442 after a single Intramuscular (IM) or Intravenous (IV) dose in pediatric participants
    Protection of trial subjects
    The study was conducted in accordance with the protocol, with the consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines for Health-related Research Involving Humans and with the applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, as well as for any applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    46
    EEA total number of subjects
    6
    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)
    4
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted from 21 March 2022 to 16 April 2024 at 11 sites in 5 countries worldwide.

    Pre-assignment
    Screening details
    		 Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442 (AZD8895 + AZD1061)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Participants received a single dose of AZD7442 as either IM (AZD8895 followed by AZD1061) or a single IV infusion (AZD8895 and AZD1061 concurrently).

    Arm title
    		 Cohort 2
    Arm description
    		 Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442 (AZD8895 + AZD1061)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Participants received a single dose of AZD7442 as either IM (AZD8895 followed by AZD1061) or a single IV infusion (AZD8895 and AZD1061 concurrently)

    Number of subjects in period 1
    		Cohort 1 Cohort 2
    Started
    44
    2
    Completed
    37
    1
    Not completed
    7
    1
         Adverse event, serious fatal
    1
    -
         Physician decision
    2
    -
         Lost to follow-up
    2
    -
         Withdrawal by parent/guardian
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).

    Reporting group values
    		 Cohort 1 Cohort 2 Total
    Number of subjects
    		 44 2 46
    Age categorical
    Units: Participants
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 3 1 4
        Children (2-11 years)
    		 20 1 21
        Adolescents (12-17 years)
    		 21 0 21
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Here, the arbitrary value 99.99 indicates that the Mean (S.D) was not calculated due to insufficient number of participants.
    Units: years
        arithmetic mean (standard deviation)
    		 10.3 ( 4.8 ) 99.99 ( 99.99 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 25 0 25
        Male
    		 19 2 21
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 11 0 11
        Multiple
    		 2 0 2
        Not Reported
    		 2 1 3
        White
    		 28 0 28
        Other
    		 1 1 2

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).

    Primary: Serum concentrations of AZD7442

    		 Close Top of page
    End point title
    		 Serum concentrations of AZD7442 [1]
    End point description
    The serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 in Day 1 and Day 366 intravenous category represents that data were not calculable due to low number of participants and in intramuscular categories and Day 11 intravenous represents that data were not available as no participants were analysed. PK analysis (PK) set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1, day 4, Day 11 and Day 366
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    20
    1
    Units: Microgram per milliliter (ug/mL)
    geometric mean (geometric coefficient of variation)
        Day 4 AZD7442 intramuscular (n: 8,0)
    86.32 ( 72.72 )
    99999 ( 99999 )
        Day 11 AZD7442 intramuscular (n: 5,0)
    92.49 ( 20.91 )
    99999 ( 99999 )
        Day 366 AZD7442 intramuscular (n: 20,0)
    4.084 ( 57.91 )
    99999 ( 99999 )
        Day 1 AZD7442 intravenous (n: 17,1)
    199.9 ( 23.16 )
    99999 ( 99999 )
        Day 11 AZD7442 intravenous (n: 6,0)
    95.02 ( 20.35 )
    99999 ( 99999 )
        Day 366 AZD7442 intravenous (n: 13,1)
    2.047 ( 74.56 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Maximum serum concentration (Cmax)

    		 Close Top of page
    End point title
    		 Maximum serum concentration (Cmax) [2]
    End point description
    The Cmax of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 in intravenous category represents that data were not calculable due to low number of participants and in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    24
    1
    Units: Microgram per milliliter (ug/mL)
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 24,0)
    92.47 ( 44.22 )
    99999 ( 99999 )
        AZD7442 intravenous (n: 19,1)
    189.3 ( 27.72 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Time to reach maximum serum concentration (tmax)

    		 Close Top of page
    End point title
    		 Time to reach maximum serum concentration (tmax) [3]
    End point description
    The tmax of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The median value 0.01 in Cohort 2 in intravenous category represents that data were not calculable due to low number of participants. The arbitrary value of 99999 in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    24
    1
    Units: Day
    median (full range (min-max))
        AZD7442 intramuscular (n: 24,0)
    11.44 (0.76 to 32.73)
    99999 (99999 to 99999)
        AZD7442 intravenous (n: 19,1)
    0.01 (0.01 to 9.95)
    0.01 (0.01 to 0.01)
    No statistical analyses for this end point

    Primary: Terminal half-life (t1/2)

    		 Close Top of page
    End point title
    		 Terminal half-life (t1/2) [4]
    End point description
    The t1/2 of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value of 99999 in intramuscular category represents that data were not available as no participants were analysed and in intravenous category represents that the data were not calculable due to low number of participants. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    1
    Units: Day
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 22,0)
    78.95 ( 24.21 )
    99999 ( 99999 )
        AZD7442 intravenous (n: 17,1)
    65.61 ( 22.38 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Area under the serum concentration versus time curve from time zero to time of last measurable concentration (AUC0-last)

    		 Close Top of page
    End point title
    		 Area under the serum concentration versus time curve from time zero to time of last measurable concentration (AUC0-last) [5]
    End point description
    The AUC0-last of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 in intravenous category represents that data were not calculable due to low number of participants and in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    23
    1
    Units: Day*ug/mL
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 23,0)
    9884 ( 42.84 )
    99999 ( 99999 )
        AZD7442 intravenous (n: 19,1)
    9342 ( 36.45 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Area under the serum concentration versus time curve extrapolated to infinity (AUC0-inf)

    		 Close Top of page
    End point title
    		 Area under the serum concentration versus time curve extrapolated to infinity (AUC0-inf) [6]
    End point description
    The AUC0-inf of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 in intravenous category represents that data were not calculable due to low number of participants and in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    1
    Units: Day*ug/mL
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 22,0)
    11000 ( 38.03 )
    99999 ( 99999 )
        AZD7442 intravenous (n: 17,1)
    10870 ( 21.09 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Time to last measurable concentration (tlast)

    		 Close Top of page
    End point title
    		 Time to last measurable concentration (tlast) [7]
    End point description
    The tlast of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The median value 354.90 in cohort 2 in intravenous category represents that data were not calculable due to low number of participants. The arbitrary value 99999 in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    24
    1
    Units: Day
    median (full range (min-max))
        AZD7442 intramuscular (n:24,0)
    351.38 (0.76 to 401.00)
    99999 (99999 to 99999)
        AZD7442 intravenous (n:19,1)
    355.97 (33.81 to 377.26)
    354.90 (354.90 to 354.90)
    No statistical analyses for this end point

    Primary: Apparent total clearance (CL/F)

    		 Close Top of page
    End point title
    		 Apparent total clearance (CL/F) [8]
    End point description
    The CL/F of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    0 [9]
    Units: Liter/day
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 22,0)
    0.04807 ( 75.26 )
    ( )
    Notes
    [9] - Number of participants analysed were 0 at this timepoint in this cohort.
    No statistical analyses for this end point

    Primary: Percentage of AUC0-inf extrapolated to infinity (% AUCex)

    		 Close Top of page
    End point title
    		 Percentage of AUC0-inf extrapolated to infinity (% AUCex) [10]
    End point description
    The %AUCex of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 in intravenous category represents that data were not calculable due to low number of participants and in intramuscular category represents that data were not available as no participants were analysed. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    1
    Units: Percentage
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 22,0)
    4.799 ( 78.26 )
    99999 ( 99999 )
        AZD7442 intravenous (n: 17,1)
    3.018 ( 179.9 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Apparent volume of distribution based on terminal phase (Vz/F)

    		 Close Top of page
    End point title
    		 Apparent volume of distribution based on terminal phase (Vz/F) [11]
    End point description
    The Vz/F of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of partcipants analyzed for each timepoint in each cohort. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    22
    0 [12]
    Units: Liter
    geometric mean (geometric coefficient of variation)
        AZD7442 intramuscular (n: 22,0)
    5.475 ( 98.74 )
    ( )
    Notes
    [12] - Number of participants analysed were 0 at this timepoint in this cohort.
    No statistical analyses for this end point

    Primary: Number of participants with adverse events

    		 Close Top of page
    End point title
    		 Number of participants with adverse events [13]
    End point description
    The safety and tolerability of AZD7442 after a single dose in pediatric participants was evaluated. Safety Analysis Set (SAF) consisted of all participants who had received investigational medicinal product (IMP).
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    44
    2
    Units: Participants
    number (not applicable)
        Any AE
    39
    2
        Any SAE
    8
    1
        Any Severe AE
    6
    0
        Any SAE with outcome death
    1
    0
        Any AE leading to study discontinuation
    0
    0
        Any possibly related AE
    3
    0
        Any possibly related SAE
    0
    0
        Any possibly related Severe AE
    0
    0
        Any possibly related AESI
    1
    0
    No statistical analyses for this end point

    Primary: Volume of distribution at steady state (Vss)

    		 Close Top of page
    End point title
    		 Volume of distribution at steady state (Vss) [14]
    End point description
    The Vss of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 represents that data were not calculable due to low number of participants. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    17
    1
    Units: Liter
    geometric mean (geometric coefficient of variation)
        AZD7442 intravenous (n: 17,1)
    2.605 ( 20.34 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Systemic clearance (CL)

    		 Close Top of page
    End point title
    		 Systemic clearance (CL) [15]
    End point description
    The CL of AZD7442 after a single dose in pediatric participants was evaluated. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The arbitrary value 99999 represents that data were not calculable due to low number of participants. PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    17
    1
    Units: Liter/day
    geometric mean (geometric coefficient of variation)
        AZD7442 intravenous (n: 17,1)
    0.02759 ( 21.09 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Primary: Number of participants with Adverse event of special interest (AESI)

    		 Close Top of page
    End point title
    		 Number of participants with Adverse event of special interest (AESI) [16]
    End point description
    Number of pediatric participants with AESI were evaluated. An AESI is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product. SAF consisted of all participants who had received IMP.
    End point type
    Primary
    End point timeframe
    Day 1 to day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study did not plan any formal hypothesis testing, only descriptive endpoints.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    44
    2
    Units: Participants
    number (confidence interval 95%)
        Intramuscular administration
    1 (0.1 to 12.0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of participants with positive antidrug antibodies (ADA) result to AZD7442.

    		 Close Top of page
    End point title
    		 Number of participants with positive antidrug antibodies (ADA) result to AZD7442.
    End point description
    The immunogenicity profile of AZD7442 after a single dose in pediatric participants was evaluated. AZD7442 ADA Evaluable Analysis Set (ADS3) consisted of all participants who were AZD8895 ADA evaluable and/or AZD1061 ADA evaluable. A participant is defined as ADA-positive to AZD7442 if they have a positive ADA result to AZD8895 and/or AZD1061 at any time, including baseline and all postbaseline.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    44
    2
    Units: Participants
    number (not applicable)
        AZD7442 intramuscular ADA positive subject
    2
    0
        AZD7442 intravenous ADA positive subject
    2
    0
    No statistical analyses for this end point

    Secondary: Cohort 2 - The incidence of COVID-19 related death occurring after dosing with IMP through 90 days in cohort 2

    		 Close Top of page
    End point title
    		 Cohort 2 - The incidence of COVID-19 related death occurring after dosing with IMP through 90 days in cohort 2 [17]
    End point description
    The incidence of COVID-19 related death occurring after dosing with IMP through 90 days in cohort 2 in pediatric participants was evaluated. SAF consisted of all participants who had received IMP.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint, only participants for one of the cohorts were analysed and the same has been presented.
    End point values
    		 Cohort 2
    Number of subjects analysed
    2
    Units: Participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Cohort 2 - Percentage of participants with progression of COVID-19 through day 29

    		 Close Top of page
    End point title
    		 Cohort 2 - Percentage of participants with progression of COVID-19 through day 29 [18]
    End point description
    Percentage of participants with progression of COVID-19 through day 29 in cohort 2 in pediatric participants was evaluated. SAF consisted of all participants who had received IMP.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint, only participants for one of the cohorts were analysed and the same has been presented.
    End point values
    		 Cohort 2
    Number of subjects analysed
    2
    Units: Participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Titre of SARS-CoV-2 neutralizing antibodies

    		 Close Top of page
    End point title
    		 Titre of SARS-CoV-2 neutralizing antibodies
    End point description
    The pharmacodynamics of AZD7442 after a single dose in pediatric participants was evaluated. The result for overall vaccination status has been presented. Here, 'n' in each row represents the number of participants analyzed for each timepoint in each cohort. The Geometric mean value 19800 in intravenous day 31 category and geometric mean value 252 in intravenous day 366 category represents that data were not calculable due to low number of participants. The arbitrary value 99999 in intramuscular category represents that data were not available as no participants were analysed. SARS-CoV-2 nAb Evaluable Analysis Set (SES) consisted of all participants in the Safety Analysis Set from whom blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum titer observation post dose.
    End point type
    Secondary
    End point timeframe
    Day 31 to Day 366 or early discontinuation visit (approx. 24 months)
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    23
    1
    Units: ug/mL
    geometric mean (full range (min-max))
        Intramuscular Day 31 (n:23,0)
    52720 (355 to 139000)
    99999 (99999 to 99999)
        Intramuscular Day 366 (n:22,0)
    1699 (143 to 4340)
    99999 (99999 to 99999)
        Intravenous Day 31 (n:18,1)
    52950 (20800 to 120000)
    19800 (19800 to 19800)
        Intravenous Day 366 (n:11,1)
    1078 (398 to 4460)
    252 (252 to 252)
    No statistical analyses for this end point

    Secondary: Cohort 1 (Prophylaxis) - Incidence of SARS-CoV-2 infections

    		 Close Top of page
    End point title
    		 Cohort 1 (Prophylaxis) - Incidence of SARS-CoV-2 infections [19]
    End point description
    The incidence of SARS-CoV-2 infections with or without COVID-19 symptoms after a single dose of AZD7442 in pediatric participants was evaluated. SAF consisted of all participants who had received IMP.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For this endpoint, only participants for one of the cohorts were analysed and the same has been presented.
    End point values
    		 Cohort 1
    Number of subjects analysed
    44
    Units: Participants
        Overall
    10
        Intramuscular administration
    7
        Intravenous administration
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).

    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)

    Serious adverse events
    		 Cohort 2 Cohort 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    8 / 44 (18.18%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile bone marrow aplasia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 2 Cohort 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    34 / 44 (77.27%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Influenza A virus test positive
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 2 (50.00%)
    7 / 44 (15.91%)
         occurrences all number
    1
    13
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Vomiting
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 2 (0.00%)
    10 / 44 (22.73%)
         occurrences all number
    0
    10
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    12 / 44 (27.27%)
         occurrences all number
    0
    27
    Viral infection
         subjects affected / exposed
    0 / 2 (0.00%)
    11 / 44 (25.00%)
         occurrences all number
    0
    13
    COVID-19
         subjects affected / exposed
    0 / 2 (0.00%)
    10 / 44 (22.73%)
         occurrences all number
    0
    10
    Acute sinusitis
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    7
    Otitis media acute
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Influenza
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    7
    Ear infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2023
    Amendment 4: Global changes to protocol - Updated last study visit from Day 457 to Day 366, removing the safety follow-up at Day 457. Section 1.1 Synopsis; Overall Design - Changed inclusion of participants in the study from 15 to 12 months following administration of IMP. Section 1.1 Synopsis; Intervention Groups and Duration - Changed monitoring of participants from 15 to 12 months after AZD7442 administration. Section 1.2 Schematic; Figures 1 and 2 - Changed Day 457 to Day 366 in Figure 1. Changed Week 65 to Week 52 in Figure 2. Section 1.3 Schedule of Activities; Tables 2 and 3 - Deleted the column related to Day 457 safety follow-up assessment in both tables. Deleted the footnote related to Day 457 safety follow-up assessment under both tables. Section 4.1 Overall Design - Deleted “Follow-up will continue through Day 457 (± 15 days) when participants will receive a telephone call to assess safety.” Changed the maximum duration of the study for each participant, including screening, from 479 to 388 days. Section 4.2.1 Rationale for Choice of Endpoints - Changed the following “The revised study duration of 366 days will allow follow-up of dosed participants through approximately 4 AZD7442 half-lives,”. Section 6.1.1 Investigational Product - Changed the following "All eligible participants will receive a single dose of AZD7442 on Day 1, either IM (AZD8895 followed by AZD1061 administered separately) or a single IV infusion (AZD8895 and AZD1061 co-administered), and participants will be monitored for 365 days after IMP administration". Section 7.4.1 Stopping Rules for an Individual Participant, at Any Time in the Study - Changed the following “Unless consent for follow-up is withdrawn, participants discontinued after receiving a partial dose of IMP will be followed for the full study period (up to and including Day 366, 52 weeks after IMP dosing)”.

    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
    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.

    European Medicines Agency © 1995-Mon May 05 17:15:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA