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    Clinical Trial Results:
    A Randomized, Controlled, Observer-Blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.Pref In RSV-Seronegative Toddlers 12 to 24 Months Of Age

    Summary
    EudraCT number
    		 2017-003859-36
    Trial protocol
    		 SE   DE   GB   FI   ES   Outside EU/EEA   PL  
    Global end of trial date
    02 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2022
    First version publication date
    15 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC18194RSV2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03606512
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines and Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, Leiden, Netherlands, 2333 CN
    Public contact
    Clinical Registry Group, Janssen Vaccines and Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines and Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002172-PIP02-17
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Feb 2019
    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
    Australia: 14
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Finland: 11
    Country: Number of subjects enrolled
    Poland: 3
    Worldwide total number of subjects
    38
    EEA total number of subjects
    14
    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)
    38
    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
    		 Total 38 subjects (20 subjects in adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein [Ad26.RSV.preF] and 18 subjects in Placebo/Nimenrix arm) were randomised and received at least 1 dose of study vaccine. Out of 38, 36 subjects completed the study (18 subjects Ad26.RSV.preF and 18 subjects in Placebo/Nimenrix arms).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo or Nimenrix
    Arm description
    		 Subjects received placebo by intramuscular (IM) injection on Days 1, 29 and 57. Placebo could be replaced with Nimenrix on Day 57 in countries where the commercial vaccine Nimenrix is licensed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nimenrix was administered as 0.5 mL solution for IM injection on Day 57.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo was administered as an IM injection on Days 1, 29 and 57.

    Arm title
    		 Ad26.RSV.preF (2.5*10^10 vp)
    Arm description
    		 Subjects received IM injection of 2.5*10^10 viral particles (vp) of an Ad26.RSV.preF on Days 1, 29, and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF
    Investigational medicinal product code
    Other name
    JNJ-64400141
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Ad26.RSV.preF was administered as an IM injection at a dose of 2.5*10^10 vp on Days 1, 29, and 57.

    Number of subjects in period 1
    		Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Started
    18
    20
    Subjects who received Nimenrix on Day 57
    12 [1]
    0 [2]
    Subjects who received Placebo on Day 57
    6 [3]
    0 [4]
    Completed
    18
    18
    Not completed
    0
    2
         Unspecified
    -
    1
         Lost to follow-up
    -
    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: Placebo was replaced with Nimenrix for 12 subjects, on Day 57 in countries where the commercial vaccine Nimenrix is licensed.
    [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: Placebo was replaced with Nimenrix for 12 subjects, on Day 57 in countries where the commercial vaccine Nimenrix is licensed.
    [3] - 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: Placebo was replaced with Nimenrix for 12 subjects, on Day 57 in countries where the commercial vaccine Nimenrix is licensed.
    [4] - 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: Placebo was replaced with Nimenrix for 12 subjects, on Day 57 in countries where the commercial vaccine Nimenrix is licensed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo or Nimenrix
    Reporting group description
    		 Subjects received placebo by intramuscular (IM) injection on Days 1, 29 and 57. Placebo could be replaced with Nimenrix on Day 57 in countries where the commercial vaccine Nimenrix is licensed.

    Reporting group title
    Ad26.RSV.preF (2.5*10^10 vp)
    Reporting group description
    		 Subjects received IM injection of 2.5*10^10 viral particles (vp) of an Ad26.RSV.preF on Days 1, 29, and 57.

    Reporting group values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp) Total
    Number of subjects
    		 18 20 38
    Title for AgeCategorical
    Units: subjects
        Infants and toddlers (28 days-23 months)
    		 18 20 38
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    		 17.8 ( 2.94 ) 16.2 ( 3.17 ) -
    Title for Gender
    Units: subjects
        Female
    		 11 11 22
        Male
    		 7 9 16

    End points

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    End points reporting groups
    Reporting group title
    Placebo or Nimenrix
    Reporting group description
    		 Subjects received placebo by intramuscular (IM) injection on Days 1, 29 and 57. Placebo could be replaced with Nimenrix on Day 57 in countries where the commercial vaccine Nimenrix is licensed.

    Reporting group title
    Ad26.RSV.preF (2.5*10^10 vp)
    Reporting group description
    		 Subjects received IM injection of 2.5*10^10 viral particles (vp) of an Ad26.RSV.preF on Days 1, 29, and 57.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received placebo by intramuscular (IM) injection on Days 1, 29 and 57.

    Subject analysis set title
    Nimenrix
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received Nimenrix by IM injection on Day 57 in countries where the commercial vaccine Nimenrix is licensed.

    Primary: Number of Subjects with Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination

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    End point title
    		 Number of Subjects with Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination [1]
    End point description
    An AE is any untoward medical event that occurs in a subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local/systemic AEs were precisely defined events that subjects were specifically asked about and which were noted by subjects in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. The Full Analysis set (FAS) included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to Day 8 (7 days after first vaccination on Day 1)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    20
    Units: Subjects
        Solicited Local AEs
    2
    6
        Solicited Systemic AEs
    11
    17
    No statistical analyses for this end point

    Primary: Number of Subjects with Solicited Local and Systemic AEs for 7 Days After Second Vaccination

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    End point title
    		 Number of Subjects with Solicited Local and Systemic AEs for 7 Days After Second Vaccination [2]
    End point description
    An AE is any untoward medical event that occurs in a subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local/systemic AEs were precisely defined events that subjects were specifically asked about and which were noted by subjects in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to Day 36 (7 days after second vaccination on Day 29)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    20
    Units: Subjects
        Solicited Local AEs
    1
    9
        Solicited Systemic AEs
    9
    11
    No statistical analyses for this end point

    Primary: Number of Subjects with Solicited Local and Systemic AEs for 7 Days After Third Vaccination

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    End point title
    		 Number of Subjects with Solicited Local and Systemic AEs for 7 Days After Third Vaccination [3] [4]
    End point description
    An AE is any untoward medical event that occurs in a subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local/systemic AEs were precisely defined events that subjects were specifically asked about and which were noted by subjects in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (Number of subjects analyzed) included all subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Day 64 (7 days after third vaccination on Day 57)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    [4] - 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: As planned, the endpoint is not reporting statistics for any of the arms of baseline period.
    End point values
    		 Ad26.RSV.preF (2.5*10^10 vp) Placebo Nimenrix
    Number of subjects analysed
    19
    6
    12
    Units: Subjects
        Solicited Local AEs
    7
    1
    4
        Solicited Systemic AEs
    12
    3
    4
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited AEs for 28 Days After First Vaccination

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    End point title
    		 Number of Subjects with Unsolicited AEs for 28 Days After First Vaccination [5]
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to Day 29 (28 days after first vaccination on Day 1)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    20
    Units: Subjects
    5
    9
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited AEs for 28 Days After Second Vaccination

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    End point title
    		 Number of Subjects with Unsolicited AEs for 28 Days After Second Vaccination [6]
    End point description
    An AE is any untoward medical event that occurs in a subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to Day 57 (28 days after second vaccination on Day 29)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    20
    Units: Subjects
    7
    9
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited AEs for 28 Days After Third Vaccination

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    End point title
    		 Number of Subjects with Unsolicited AEs for 28 Days After Third Vaccination [7] [8]
    End point description
    An AE is any untoward medical event that occurs in a subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (Number of subjects analyzed) included all subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Day 85 (28 days after third vaccination on Day 57)
    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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    [8] - 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: As planned, the endpoint is not reporting statistics for any of the arms of baseline period.
    End point values
    		 Ad26.RSV.preF (2.5*10^10 vp) Placebo Nimenrix
    Number of subjects analysed
    19
    6
    12
    Units: Subjects
    7
    3
    3
    No statistical analyses for this end point

    Primary: Number of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects with Serious Adverse Events (SAEs) [9] [10]
    End point description
    Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to 1 year and 9 months
    Notes
    [9] - 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: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    [10] - 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: As planned, the endpoint is not reporting statistics for any of the arms of baseline period.
    End point values
    		 Ad26.RSV.preF (2.5*10^10 vp) Placebo Nimenrix
    Number of subjects analysed
    20
    6
    12
    Units: Subjects
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain

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    End point title
    		 Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
    End point description
    Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units. The seropositivity cut-off for this assay is an IC50 of 42.7 for RSV A2. The Per-protocol Immunogenicity (PPI) analysis set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) is defined as subjects analyzed for specified time points. Here, values below the seropositivity cut-off (less than [<] 42.7) were imputed with zero.
    End point type
    Secondary
    End point timeframe
    Days 1, 8, 85, and 267 (End of first RSV season)
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    19
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1 (n=18,19)
    0 (0 to 0)
    0 (0 to 0)
        Day 8 (n=17,18)
    0 (0 to 0)
    0 (0 to 52)
        Day 85 (n=16,14)
    0 (0 to 45)
    293 (240 to 358)
        Day 267 (End of first RSV season) (n=15,9)
    0 (0 to 46)
    269 (115 to 632)
    No statistical analyses for this end point

    Secondary: Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    		 Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
    End point description
    Pre-fusion A IgG serum antibody response was assessed by ELISA. The PPI analysis set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) is defined as subjects analyzed for specified time points. Here, 99999 signifies that data point could not be calculated since all values were below the cut-off value. Here, values below the seropositivity cut-off (<16.1) were imputed with zero.
    End point type
    Secondary
    End point timeframe
    Days 1, 8, 85, and 267 (End of first RSV season)
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    19
    Units: ELISA units per liter (EU/L)
    geometric mean (confidence interval 95%)
        Day 1 (n=18,19)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        Day 8 (n=17,19)
    0 (-99999 to 99999)
    0 (0 to 0)
        Day 85 (n=16,14)
    0 (0 to 0)
    236 (187 to 299)
        Day 267 (End of first RSV season) (n=15,9)
    0 (0 to 27)
    212 (79 to 571)
    No statistical analyses for this end point

    Secondary: Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA

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    End point title
    		 Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
    End point description
    Post-fusion A IgG serum antibody response as assessed by ELISA was reported. The PPI analysis set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) is defined as subjects analyzed for specified time points. Here, 99999 signifies that data point could not be calculated, since all values were below the cut-off value. Here, values below the seropositivity cut-off (<17.0) were imputed with zero.
    End point type
    Secondary
    End point timeframe
    Days 1, 8, 85, and 267 (End of first RSV season)
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    19
    Units: EU/L
    geometric mean (confidence interval 95%)
        Day 1 (n=18,19)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        Day 8 (n=16,19)
    0 (-99999 to 99999)
    0 (0 to 0)
        Day 85 (n=16,14)
    0 (0 to 0)
    47 (40 to 54)
        Day 267 (End of first RSV season) (n=15,9)
    0 (0 to 30)
    58 (22 to 153)
    No statistical analyses for this end point

    Secondary: T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry

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    End point title
    		 T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
    End point description
    T-cell response (%) to RSV F peptides for T-helper Th1 and Th2 subtyping as measured by flow cytometry was assessed. Th1(% of CD4+ interferon gamma [IFN-g]+T cells; LLOQ=0.05%) and Th2 (% of CD4+ interleukin [IL]-4+/IL-13+ and CD40L+T cells; LLOQ=0.07%) responses were determined by intracellular cytokines after RSV F peptide stimulation. PPI analysis set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (Number analyzed) included all subjects evaluable for this endpoint and 'n' (number analyzed) defined as subjects analyzed for specified timepoints. Here 99999 refer that due to low number of viable PBMCs, the positive control in the ICS assay (Staphylococcal enterotoxin B [SEB]) could not be performed for all samples and an analysis was thought not to be informative on such a limited amount of datapoints so no conclusions can be drawn.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    13
    16
    Units: % CD4+ T-cells
    median (inter-quartile range (Q1-Q3))
        CD4: Th1: IFN-gamma: Baseline (n=13,16)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD4: Th1: IFN-gamma: Day 85 (n=9,8)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD4: Th2: IL4/IL13 and CD40L: Baseline (n=13,16)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD4: Th2: IL4/IL13 and CD40L Day 85 (n=9,8)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Severe RSV-lower Respiratory Tract Infection (LRTI)

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    End point title
    		 Number of Subjects with Severe RSV-lower Respiratory Tract Infection (LRTI)
    End point description
    Number of subjects with severe RSV-LRTI were reported. The Modified Intent-to-treat (mITT) analysis set is defined as a subset of the FAS excluding subjects who are seronegative at screening but for whom there is an anamnestic response at Day 8.
    End point type
    Secondary
    End point timeframe
    Up to 1 year 9 months
    End point values
    		 Placebo or Nimenrix Ad26.RSV.preF (2.5*10^10 vp)
    Number of subjects analysed
    18
    19
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 1 year 9 months
    Adverse event reporting additional description
    The Full Analysis set (FAS) included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Ad26.RSV.preF (2.5*10^10 vp)
    Reporting group description
    		 Subjects received IM injection of 2.5*10^10 viral particles (vp) of an Ad26.RSV.preF on Days 1, 29, and 57.

    Reporting group title
    Placebo or Nimenrix
    Reporting group description
    		 Subjects received placebo by intramuscular (IM) injection on Days 1, 29 and 57. Placebo could be replaced with Nimenrix on Day 57 in countries where the commercial vaccine Nimenrix is licensed.

    Serious adverse events
    		 Ad26.RSV.preF (2.5*10^10 vp) Placebo or Nimenrix
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (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: 0%
    Non-serious adverse events
    		 Ad26.RSV.preF (2.5*10^10 vp) Placebo or Nimenrix
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 20 (75.00%)
    14 / 18 (77.78%)
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Skin Abrasion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Skin Laceration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Thermal Burn
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Drooling
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection Site Bruising
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Tenderness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Middle Ear Effusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergy to Arthropod Bite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Abdominal Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Teething
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Nasal Congestion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash Macular
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Miliaria
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Dry Skin
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Dermatitis Diaper
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Croup Infectious
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Exanthema Subitum
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    Oral Viral Infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Otitis Media
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    4
    Otitis Media Acute
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Rhinitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Respiratory Tract Infection
         subjects affected / exposed
    4 / 20 (20.00%)
    5 / 18 (27.78%)
         occurrences all number
    5
    5
    Pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Rhinovirus Infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 18 (11.11%)
         occurrences all number
    17
    5
    Viral Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 18 (5.56%)
         occurrences all number
    6
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2018
    The protocol amendment was made to remove seropositive subjects from the study so that seronegative toddlers can be evaluated independent of any findings that might occur in seropositive toddlers at the 1*10^11 viral particles (vp) dose level.
    13 Jul 2018
    The protocol amendment was made to reduce the dose of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) from 5*10^10 vp to 2.5*10^10 vp.
    07 Nov 2018
    The protocol amendment was made to incorporate vaccination with Nimenrix as an alternative for the Day 57 vaccination with placebo (0.9 percent [%] saline) for subjects in the control group (in accordance with the local label and local regulations, and unless contra-indicated).
    08 Apr 2019
    To introduce more active follow-up of ongoing respiratory tract infection (RTIs)/otitis media cases to capture the potential worsening of RTI/otitis media cases that are reported as not severe during the initial RTI visit and to clarify the responsibilities of the clinical endpoint committee (CEC) in terms of evaluation of RTI cases and severity grading of RTIs.
    05 Jul 2019
    This amendment was made to align the global protocol with changes made requests from the German Health Authority.
    25 May 2020
    This protocol amendment was made primarily to reduce the overall number of RSV-seronegative toddlers in the study from 48 to 36.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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