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    Clinical Trial Results:
    A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to <6 Months (BabyCOVE)

    Summary
    EudraCT number
    		 2023-000482-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2025
    First version publication date
    29 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    mRNA-1273-P206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05584202
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ModernaTX, Inc
    Sponsor organisation address
    325 Binney Street, Cambridge, MA, United States, 02142
    Public contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com
    Scientific contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002893-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
    04 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months. The study was planned to be conducted in 2 parts (open-label in Part 1 and observer-blind, randomized, placebo-controlled in Part 2). Enrollment for the study was paused after an updated COVID-19 vaccine in children 6 months to <12 years of age was granted emergency use authorization (EUA) in the United (US). Enrollment in the study was subsequently discontinued based on immunogenicity results from Part 1, and accordingly Part 2 of the study was not initiated. This discontinuation was not related to any safety concerns.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and other applicable laws and regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    68
    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)
    68
    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
    		 Participants eligible for enrollment in Part 1 of this study included male and female infants aged 12 weeks to <6 months at the time of administration of first dose who were in good general health.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 mRNA-1273.214 5 μg
    Arm description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 5 micrograms (μg) by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    		 mRNA-1273.214 10 μg
    Arm description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1
    		mRNA-1273.214 5 μg mRNA-1273.214 10 μg
    Started
    50
    18
    Received First Injection
    50
    18
    Received Second Injection
    49
    15
    Safety Set
    50
    18
    Solicited Safety Set First Injection
    50
    18
    Solicited Safety Set Second Injection
    49
    15
    Per-Protocol Immunogenicity Set (PPIS)
    37 [1]
    11 [2]
    Completed
    45
    14
    Not completed
    5
    4
         Withdrawal of Consent
    3
    2
         Death
    -
    1
         Lost to follow-up
    2
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPIS analysis population
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPIS analysis population

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    mRNA-1273.214 5 μg
    Reporting group description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 5 micrograms (μg) by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).

    Reporting group title
    mRNA-1273.214 10 μg
    Reporting group description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Reporting group values
    		 mRNA-1273.214 5 μg mRNA-1273.214 10 μg Total
    Number of subjects
    		 50 18 68
    Age Categorical
    Units: Subjects
        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)
    		 50 18 68
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 26 4 30
        Male
    		 24 14 38

    End points

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    End points reporting groups
    Reporting group title
    mRNA-1273.214 5 μg
    Reporting group description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 5 micrograms (μg) by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).

    Reporting group title
    mRNA-1273.214 10 μg
    Reporting group description
    		 Participants received at least 1 of the 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Subject analysis set title
    mRNA-1273.214 5 μg (Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received at least 1 of 2 doses of mRNA-1273.214 5 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Subject analysis set title
    mRNA-1273.214 10 μg (Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received at least 1 of 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Subject analysis set title
    mRNA-1273.214 5 μg First Injection (Solicited Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received first injection of mRNA-1273.214 5 μg.

    Subject analysis set title
    mRNA-1273.214 10 μg First Injection (Solicited Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received first injection of mRNA-1273.214 10 μg.

    Subject analysis set title
    mRNA-1273.214 5 μg Second Injection (Solicited Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second injection of mRNA-1273.214 5 μg.

    Subject analysis set title
    mRNA-1273.214 10 μg Second Injection (Solicited Safety Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second injection of mRNA-1273.214 10 μg.

    Subject analysis set title
    mRNA-1273.214 5 μg (PPIS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received the planned doses of mRNA-1273.214 5 μg per schedule, complied with immunogenicity testing schedule, had Baseline (Day 1) and Day 85 antibody assessments, and had no major protocol deviations that impacted key or critical data.

    Subject analysis set title
    mRNA-1273.214 10 μg (PPIS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received the planned doses of mRNA-1273.214 10 μg per schedule, complied with immunogenicity testing schedule, had Baseline (Day 1) and Day 85 antibody assessments, and had no major protocol deviations that impacted key or critical data.

    Primary: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) After First Injection

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    End point title
    		 Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) After First Injection [1]
    End point description
    Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to <6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. Solicited Safety Set included participants who received the first injection of study drug and contributed any solicited AR data. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section.
    End point type
    Primary
    End point timeframe
    Day 1 up to 7 days after first vaccination (up to Day 8)
    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: As prespecified in the the protocol, no statistical analysis was conducted for this endpoint.
    End point values
    		 mRNA-1273.214 5 μg First Injection (Solicited Safety Set) mRNA-1273.214 10 μg First Injection (Solicited Safety Set)
    Number of subjects analysed
    50
    18
    Units: participants
    number (not applicable)
        Grade 1
    23
    7
        Grade 2
    8
    3
        Grade 3
    1
    0
        Grade 4
    0
    0
        Any solicited ARs (Grade 1-4)
    32
    10
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Local and Systemic ARs After Second Injection

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    End point title
    		 Number of Participants With Solicited Local and Systemic ARs After Second Injection [2]
    End point description
    Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to <6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. Solicited Safety Set included participants who received the second injection of study drug and contributed any solicited AR data. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section.
    End point type
    Primary
    End point timeframe
    Day 57 up to 7 days after second vaccination (up to Day 64)
    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: As prespecified in the the protocol, no statistical analysis was conducted for this endpoint.
    End point values
    		 mRNA-1273.214 5 μg Second Injection (Solicited Safety Set) mRNA-1273.214 10 μg Second Injection (Solicited Safety Set)
    Number of subjects analysed
    49
    15
    Units: participants
    number (not applicable)
        Grade 1
    18
    6
        Grade 2
    7
    2
        Grade 3
    1
    0
        Grade 4
    0
    0
        Any solicited ARs (Grade 1-4)
    26
    8
    No statistical analyses for this end point

    Primary: Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection

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    End point title
    		 Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection [3]
    End point description
    An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol‑defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. Safety Set included participants who received at least 1 dose of study drug. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.
    End point type
    Primary
    End point timeframe
    Day 1 up to 28 days after any vaccination (up to Day 85)
    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: As prespecified in the the protocol, no statistical analysis was conducted for this endpoint.
    End point values
    		 mRNA-1273.214 5 μg (Safety Set) mRNA-1273.214 10 μg (Safety Set)
    Number of subjects analysed
    50
    18
    Units: participants
        number (not applicable)
    24
    8
    No statistical analyses for this end point

    Primary: Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation

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    End point title
    		 Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation [4]
    End point description
    SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID‑19 or were of interest in COVID‑19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site [for example, urgent care, primary care physician]). A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 422
    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: As prespecified in the the protocol, no statistical analysis was conducted for this endpoint.
    End point values
    		 mRNA-1273.214 5 μg (Safety Set) mRNA-1273.214 10 μg (Safety Set)
    Number of subjects analysed
    50
    18
    Units: participants
    number (not applicable)
        SAEs
    1
    1
        AESIs
    1
    0
        MAAEs
    39
    16
        AEs Leading to Study or Treatment Discontinuation
    0
    1
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) of Serum Pseudovirus Neutralizing Antibody (nAb) Titers Against SARS-CoV-2 Omicron BA.1 Variant (B.1.1.529) After Second Dose of mRNA-1273.214

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    End point title
    		 Geometric Mean Concentration (GMC) of Serum Pseudovirus Neutralizing Antibody (nAb) Titers Against SARS-CoV-2 Omicron BA.1 Variant (B.1.1.529) After Second Dose of mRNA-1273.214
    End point description
    Pseudovirus nAb were measured using pseudovirus neutralization assay (PsVNA). Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. VAC122 Neutralizing Antibody against the SARS-CoV-2 B.1.1.529 variant (LLOQ: 8 arbitrary unit (AU)/milliliter (mL), ULOQ: 24503 AU/mL). Per-protocol Immunogenicity Set (PPIS): participants who received the planned doses of investigational product per schedule, complied with immunogenicity testing schedule, had Baseline (Day 1) and Day 85 antibody assessments, and had no major protocol deviations that impacted key or critical data.
    End point type
    Secondary
    End point timeframe
    Baseline and 28 days after second dose (Day 85)
    End point values
    		 mRNA-1273.214 5 μg (PPIS) mRNA-1273.214 10 μg (PPIS)
    Number of subjects analysed
    37 [5]
    11 [6]
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline
    64.9 (42.3 to 99.6)
    84.2 (42.8 to 165.5)
        Day 85
    163.0 (91.0 to 292.2)
    228.6 (97.0 to 538.9)
    Notes
    [5] - Baseline n=37, Day 85 n=37
    [6] - Baseline n=11, Day 85 n=11
    No statistical analyses for this end point

    Secondary: GMC of Serum Pseudovirus nAb Titers Against SARS-CoV-2 Original Strain (D614G) After Second Dose of mRNA-1273.214

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    End point title
    		 GMC of Serum Pseudovirus nAb Titers Against SARS-CoV-2 Original Strain (D614G) After Second Dose of mRNA-1273.214
    End point description
    Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. VAC62 Neutralizing Antibody against D614G (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). PPIS: participants who received the planned doses of investigational product per schedule, complied with immunogenicity testing schedule, had Baseline (Day 1) and Day 85 antibody assessments, and had no major protocol deviations that impacted key or critical data. Overall number of participants analyzed = participants evaluable for the endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and 28 days after second dose (Day 85)
    End point values
    		 mRNA-1273.214 5 μg (PPIS) mRNA-1273.214 10 μg (PPIS)
    Number of subjects analysed
    37 [7]
    11 [8]
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline
    236.4 (150.8 to 370.6)
    203.6 (76.6 to 540.9)
        Day 85
    178.1 (133.3 to 237.9)
    96.0 (72.2 to 127.6)
    Notes
    [7] - Baseline n=37, Day 85 n=36
    [8] - Baseline n=11, Day 85 n=11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Day 422
    Adverse event reporting additional description
    Safety Set included participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    mRNA-1273.214 10 ug
    Reporting group description
    		 Participants received at least 1 of 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Reporting group title
    mRNA-1273.214 5 ug
    Reporting group description
    		 Participants received at least 1 of 2 doses of mRNA-1273.214 5 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57).

    Serious adverse events
    		 mRNA-1273.214 10 ug mRNA-1273.214 5 ug
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 50 (2.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Cardiac disorders
    Cardiac arrest
    Additional description: Cardiac arrest resulting from drowning.
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoxic-ischaemic encephalopathy
    Additional description: Hypoxic-ischaemic encephalopathy resulting from drowning.
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (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
    Rhinovirus infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 50 (2.00%)
         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
    		 mRNA-1273.214 10 ug mRNA-1273.214 5 ug
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 18 (88.89%)
    40 / 50 (80.00%)
    Investigations
    Blood lead increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Speech disorder developmental
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 50 (10.00%)
         occurrences all number
    4
    5
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 50 (6.00%)
         occurrences all number
    1
    4
    Diarrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Teething
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 50 (12.00%)
         occurrences all number
    1
    6
    Vomiting
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    3 / 18 (16.67%)
    5 / 50 (10.00%)
         occurrences all number
    8
    7
    Nasal congestion
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 50 (10.00%)
         occurrences all number
    3
    5
    Rhinitis allergic
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    Eczema
         subjects affected / exposed
    0 / 18 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    5
    Infections and infestations
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Candida nappy rash
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Conjunctivitis
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    Conjunctivitis bacterial
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 50 (8.00%)
         occurrences all number
    4
    4
    Coronavirus infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 50 (6.00%)
         occurrences all number
    2
    6
    Gastroenteritis
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    4
    Bronchiolitis
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 50 (12.00%)
         occurrences all number
    1
    7
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 18 (22.22%)
    9 / 50 (18.00%)
         occurrences all number
    12
    23
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 18 (38.89%)
    16 / 50 (32.00%)
         occurrences all number
    12
    39
    Rhinovirus infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    3
    0
    Rhinitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    2 / 18 (11.11%)
    7 / 50 (14.00%)
         occurrences all number
    2
    7
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Otosalpingitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    3 / 18 (16.67%)
    12 / 50 (24.00%)
         occurrences all number
    9
    17
    Influenza
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 50 (4.00%)
         occurrences all number
    2
    2
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 50 (8.00%)
         occurrences all number
    2
    4
    Gastroenteritis viral
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 50 (6.00%)
         occurrences all number
    3
    3
    Otitis media acute
         subjects affected / exposed
    4 / 18 (22.22%)
    9 / 50 (18.00%)
         occurrences all number
    10
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Sep 2023
    Enrollment was paused on 18-Sep-2023 since an updated formulation was available under EUA. Enrollment was eventually discontinued in May 2024 based on interim immunogenicity results from Part 1, and neither dose level could be advanced for further evaluation. Accordingly Part 2 of the study was not initiated. Enrollment discontinuation was not related to any safety concerns.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Based on immunogenicity results from Part 1, Part 2 was not conducted. Results should be interpreted with caution due to the small sample size of Part 1 Arm 2.
    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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