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    Clinical Trial Results:
    A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age and RSV-Seropositive Toddlers 12 to 24 Months of Age

    Summary
    EudraCT number
    2017-001345-27
    Trial protocol
    GB   FI   Outside EU/EEA  
    Global end of trial date
    21 Apr 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Nov 2020
    First version publication date
    06 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC18194RSV2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03303625
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines and Prevention B.V.
    Sponsor organisation address
    Newtonweg 1, Leiden, Netherlands, 2333 CM
    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
    03 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety and tolerability of an intramuscular regimen of 2 doses of 1*10^11 viral particles (vp) of Ad26.RSV.preF in adults aged 18 to 50 years and 2 doses of 5*10^10 vp of Ad26.RSV.preF in respiratory syncytial virus (RSV)-seropositive 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. Safety Evaluations included adverse events (AEs), including solicited local and systemic AEs, unsolicited AEs, and serious AEs (SAEs), respiratory tract infection (RTIs) (Cohort 1 only), clinical laboratory tests (Cohort 0 only), vital signs, physical examination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Dec 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Finland: 15
    Worldwide total number of subjects
    48
    EEA total number of subjects
    46
    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)
    36
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    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 48 subjects were randomized out of which 46 completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 0 (18 to 50 years): Ad26.RSV.preF
    Arm description
    Subjects received a single intramuscular (IM) injection of 1*10^11 viral particles (vp) adenovirus serotype 26 vectored vaccine expressing the pre-fusion F-protein of the respiratory syncytial virus A2 strain (Ad26.RSV.preF) on Day 1 and Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.RSV.preF
    Investigational medicinal product code
    Other name
    JNJ-64400141
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Ad26.RSV.preF was administered 1*10^11 vp as 0.5 mL injection for adults.

    Arm title
    Cohort 0 (18 to 50 years): Placebo
    Arm description
    Subjects received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo was administered as sterile 0.9% saline for injection.

    Arm title
    Cohort 1 (12 to 24 months): Ad26.RSV.preF
    Arm description
    Subjects (seropositive for respiratory syncytial virus [RSV] within 42 days prior to vaccination) received single IM injection of 5*10^10 vp Ad26.RSV.preF on Day 1 and Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.RSV.preF
    Investigational medicinal product code
    Other name
    JNJ-64400141
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Ad26.RSV.preF was administered as 5*10^10 vp as 0.25 mL injection for toddlers.

    Arm title
    Cohort 1 (12 to 24 months): Placebo
    Arm description
    Subjects (seropositive for RSV within 42 days prior to vaccination) received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo was administered as sterile 0.9% saline for injection.

    Number of subjects in period 1
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Started
    8
    4
    24
    12
    Completed
    6
    4
    24
    12
    Not completed
    2
    0
    0
    0
         Withdrawal by subject
    2
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 0 (18 to 50 years): Ad26.RSV.preF
    Reporting group description
    Subjects received a single intramuscular (IM) injection of 1*10^11 viral particles (vp) adenovirus serotype 26 vectored vaccine expressing the pre-fusion F-protein of the respiratory syncytial virus A2 strain (Ad26.RSV.preF) on Day 1 and Day 29.

    Reporting group title
    Cohort 0 (18 to 50 years): Placebo
    Reporting group description
    Subjects received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Ad26.RSV.preF
    Reporting group description
    Subjects (seropositive for respiratory syncytial virus [RSV] within 42 days prior to vaccination) received single IM injection of 5*10^10 vp Ad26.RSV.preF on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Placebo
    Reporting group description
    Subjects (seropositive for RSV within 42 days prior to vaccination) received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Reporting group values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo Total
    Number of subjects
    8 4 24 12 48
    Title for AgeCategorical
    Units: subjects
        Infants and toddlers (28 days-23 months)
    0 0 24 12 36
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    8 4 0 0 12
        From 65 to 84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Title for AgeContinuous
    Units: Years (Cohort 0) and Months (Cohort 1)
    Units: years
        median (full range (min-max))
    37.5 (28 to 47) 32.0 (27 to 41) 18 (13 to 23) 17 (14 to 23) -
    Title for Gender
    Units: subjects
        Female
    6 2 13 8 29
        Male
    2 2 11 4 19

    End points

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    End points reporting groups
    Reporting group title
    Cohort 0 (18 to 50 years): Ad26.RSV.preF
    Reporting group description
    Subjects received a single intramuscular (IM) injection of 1*10^11 viral particles (vp) adenovirus serotype 26 vectored vaccine expressing the pre-fusion F-protein of the respiratory syncytial virus A2 strain (Ad26.RSV.preF) on Day 1 and Day 29.

    Reporting group title
    Cohort 0 (18 to 50 years): Placebo
    Reporting group description
    Subjects received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Ad26.RSV.preF
    Reporting group description
    Subjects (seropositive for respiratory syncytial virus [RSV] within 42 days prior to vaccination) received single IM injection of 5*10^10 vp Ad26.RSV.preF on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Placebo
    Reporting group description
    Subjects (seropositive for RSV within 42 days prior to vaccination) received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Primary: Number of Subjects with at Least one Solicited Local Adverse Events (AEs)

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    End point title
    Number of Subjects with at Least one Solicited Local Adverse Events (AEs) [1]
    End point description
    Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Subjects were instructed to record occurrences of solicited local AEs in a diary from the day of vaccination (Day 1) to Day 8. The Full Analysis (FA) Set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. All safety analyses were based on the FA set. Here, 'n' (number analyzed) signifies the number of subjects evaluable at a specified timepoint.
    End point type
    Primary
    End point timeframe
    7 days after each vaccination (up to 36 days)
    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: No inferential statistics was planned for the primary endpoints.
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    4
    24
    12
    Units: subjects
        Post Vaccination 1: n=8, 4, 24, 12
    8
    1
    14
    4
        Post Vaccination 2: n=6, 4, 24, 12
    6
    0
    14
    4
    No statistical analyses for this end point

    Primary: Number of Subjects with at Least one Solicited Systemic Adverse Events

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    End point title
    Number of Subjects with at Least one Solicited Systemic Adverse Events [2]
    End point description
    Solicited systemic AEs included fatigue/lethargy, headache, nausea/vomiting, myalgia and fever/pyrexia (defined as body temperature 38 degree Celsius or higher and derived from the oral temperature measurement), diarrhea, irritability/crying, loss of appetite. The Full analysis (FA) Set 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 analyzed) signifies the number of subjects evaluable at a specified timepoint. Here, '99999' indicates that the data for the particular category at the specified time-point were not applicable and collected.
    End point type
    Primary
    End point timeframe
    7 days after each vaccination (up to 36 days)
    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: No inferential statistics was planned for the primary endpoints.
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    4
    24
    12
    Units: subjects
        Arthralgia: Post Vaccination 1: n=8, 4
    5
    0
    99999
    99999
        Chills: Post Vaccination 1: n=8, 4
    4
    0
    99999
    99999
        Fatigue: Post Vaccination 1: n=8, 4, 24, 12
    6
    0
    18
    6
        Headache: Post Vaccination 1: n=8, 4
    4
    1
    99999
    99999
        Myalgia: Post Vaccination 1: n=8, 4
    8
    0
    99999
    99999
        Nausea: Post Vaccination 1: n=8, 4, 24, 12
    5
    0
    8
    2
        Pyrexia: Post Vaccination 1: n=8, 4, 24, 12
    4
    0
    13
    1
        Arthralgia: Post Vaccination 2: n=6, 4
    1
    0
    99999
    99999
        Chills: Post Vaccination 2: n=6, 4
    1
    0
    99999
    99999
        Fatigue: Post Vaccination 2: n=6, 4, 24, 12
    2
    1
    17
    4
        Headache: Post Vaccination 2: n=6, 4
    2
    1
    99999
    99999
        Myalgia: Post Vaccination 2: n=6, 4
    2
    0
    99999
    99999
        Nausea: Post Vaccination 2: n=6, 4, 24, 12
    1
    0
    6
    0
        Pyrexia: Post Vaccination 2: n=6, 4, 24, 12
    0
    0
    10
    2
        Diarrhea: Post Vaccination 1: n= 24, 12
    99999
    99999
    3
    4
        Irritability: Post Vaccination 1: n= 24, 12
    99999
    99999
    19
    10
        Loss of appetite: Post Vaccination 1: n= 24, 12
    99999
    99999
    19
    7
        Diarrhea: Post Vaccination 2: n= 24, 12
    99999
    99999
    5
    3
        Irritability: Post Vaccination 2: n= 24, 12
    99999
    99999
    19
    9
        Loss of appetite: Post Vaccination 2: n= 24, 12
    99999
    99999
    17
    6
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited Adverse Events

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    End point title
    Number of Subjects with Unsolicited Adverse Events [3]
    End point description
    Unsolicited adverse events included all adverse events for which the subject is not specifically questioned in the participant diary. The Full analysis (FA) Set 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 analyzed) signifies the number of subjects evaluable at a specified timepoint.
    End point type
    Primary
    End point timeframe
    Up to 28 days after the each vaccination (up to 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: No inferential statistics was planned for the primary endpoints.
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    4
    24
    12
    Units: subjects
        Post Vaccination 1: n=8, 4, 24, 12
    5
    0
    11
    8
        Post Vaccination 2: n=6, 4, 24, 12
    4
    1
    12
    6
    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) [4]
    End point description
    SAEs are any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important, is a suspected transmission of any infectious agent via a medicinal product. The Full analysis (FA) Set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. There were no SAEs reported for Cohort 0.
    End point type
    Primary
    End point timeframe
    Up to 1 year
    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: No inferential statistics was planned for the primary endpoints.
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    4
    24
    12
    Units: subjects
    0
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Geometric Mean Titre of Neutralizing Antibodies Against Respiratory Syncytial Virus (RSV) A2 Strain

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    End point title
    Geometric Mean Titre of Neutralizing Antibodies Against Respiratory Syncytial Virus (RSV) A2 Strain
    End point description
    Geometric mean titre of neutralizing antibody against RSV A2 strain were assessed using an RSV neutralization assay. The Per-protocol Immunogenicity (PPI) Set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subject samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of subjects evaluable at a specified timepoint.
    End point type
    Secondary
    End point timeframe
    Days 29, 57 and 211
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    4
    24
    12
    Units: Titers (IC50 units)
    geometric mean (confidence interval 95%)
        Post Vaccination 1 (Day 29): n=6, 3, 17, 7
    1089 (483 to 2456)
    603 (101 to 3596)
    1608 (730 to 3544)
    156 (68 to 358)
        Post Vaccination 2 (Day 57): n=6, 3, 17, 8
    926 (485 to 1769)
    566 (114 to 2805)
    2235 (1586 to 3150)
    198 (89 to 441)
        Post Vaccination 2 (Day 211): n=6, 3, 16, 7
    704 (325 to 1526)
    574 (139 to 2374)
    1164 (734 to 1847)
    165 (70 to 387)
    No statistical analyses for this end point

    Secondary: Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response

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    End point title
    Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response
    End point description
    Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines. The PPI Set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subject samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of subjects evaluable at a specified timepoint. Here, '99999' indicates that the data for the particular arm at the specified time-point were not evaluable. Here 'N' (Number of subjects analyzed) included all subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Days 29 and 57
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    4
    3
    13
    8
    Units: Percentage of cytokines subset
    median (inter-quartile range (Q1-Q3))
        CD4: Post Vaccination 1 (Day 29): n=3, 3, 13, 8
    0.170 (0.100 to 0.210)
    0.060 (0.050 to 0.080)
    0.089 (0.062 to 0.131)
    0.074 (0.056 to 0.123)
        CD4: Post Vaccination 2 (Day 57): n=4, 3
    0.150 (0.110 to 0.350)
    0.040 (0.020 to 0.120)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD8: Post Vaccination 1 (Day 29): n=3, 3, 14, 8
    0.150 (0.080 to 0.230)
    0.090 (0.020 to 0.110)
    0.077 (0.024 to 0.116)
    0.053 (0.016 to 0.110)
        CD8: Post Vaccination 2 (Day 57): n=4, 3
    0.080 (0.070 to 0.210)
    0.060 (0.000 to 0.190)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Th1: Post Vaccination 1 (Day 29): n=4, 3, 13, 8
    0.098 (0.040 to 0.146)
    0.049 (0.037 to 0.057)
    0.034 (0.025 to 0.078)
    0.028 (0.017 to 0.055)
        Th1: Post Vaccination 2 (Day 57): n=4, 3
    0.112 (0.083 to 0.302)
    0.039 (0.008 to 0.061)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Th2: Post Vaccination 1 (Day 29): n=4, 3, 13, 8
    0.003 (0.002 to 0.006)
    0.001 (0.001 to 0.001)
    0.005 (0.001 to 0.007)
    0.003 (0.002 to 0.007)
        Th2: Post Vaccination 2 (Day 57): n=4, 3
    0.003 (0.001 to 0.022)
    0.001 (0.001 to 0.001)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Antibody Response of RSV Pre- and Post- Fusion Protein (ELISA)

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    End point title
    Antibody Response of RSV Pre- and Post- Fusion Protein (ELISA)
    End point description
    Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form was performed using Elisa. The PPI Set included all randomized and vaccinated subjects for whom immunogenicity data are available, excluding subject samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (Number of subjects analyzed) included all subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies the number of subjects evaluable at a specified timepoint.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57 and 211
    End point values
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Number of subjects analysed
    8
    3
    17
    9
    Units: Elisa units per liter (EU/L)
    geometric mean (confidence interval 95%)
        preF: Post Vaccination 1 (Day 1): n=8, 3, 17, 9
    197 (132 to 295)
    249 (50 to 1234)
    59 (36 to 97)
    113 (57 to 223)
        preF: Post Vaccination 1 (Day 29): n=6, 3, 17, 8
    441 (304 to 639)
    261 (60 to 1138)
    1174 (524 to 2630)
    106 (56 to 199)
        preF: Post Vaccination 2 (Day 57): n=6, 3, 17, 8
    481 (317 to 729)
    244 (60 to 992)
    1918 (1497 to 2456)
    148 (54 to 402)
        preF: Post Vaccination 2 (Day 211): n=6, 3, 16, 7
    418 (264 to 664)
    292 (45 to 1895)
    924 (639 to 1334)
    120 (39 to 370)
        postF: Post Vaccination 2 (Day 1): n=8, 3, 17, 9
    196 (112 to 346)
    191 (19 to 1879)
    77 (48 to 125)
    94 (46 to 190)
        postF: Post Vaccination 2 (Day 29): n=6, 3, 17, 8
    328 (207 to 521)
    207 (25 to 1738)
    686 (371 to 1268)
    86 (47 to 158)
        postF: Post Vaccination 2 (Day 57): n=6, 3, 17, 8
    341 (198 to 589)
    179 (23 to 1370)
    863 (630 to 1184)
    109 (52 to 232)
        postF: Post Vaccination 2 (Day 211): n=6, 3, 16, 7
    268 (142 to 507)
    181 (18 to 1870)
    420 (306 to 576)
    91 (33 to 256)
    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
    Adverse event reporting additional description
    Safety data were analyzed for all subjects who were randomized and received at least 1 dose of study vaccine.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 0 (18 to 50 years): Ad26.RSV.preF
    Reporting group description
    Subjects received a single intramuscular (IM) injection of 1*10^11 viral particles (vp) adenovirus serotype 26 vectored vaccine expressing the pre-fusion F-protein of the respiratory syncytial virus A2 strain (Ad26.RSV.preF) on Day 1 and Day 29.

    Reporting group title
    Cohort 0 (18 to 50 years): Placebo
    Reporting group description
    Subjects received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Ad26.RSV.preF
    Reporting group description
    Subjects (seropositive for RSV within 42 days prior to vaccination) received single IM injection of 5*10^10 vp Ad26.RSV.preF on Day 1 and Day 29.

    Reporting group title
    Cohort 1 (12 to 24 months): Placebo
    Reporting group description
    Subjects (seropositive for RSV within 42 days prior to vaccination) received single IM injection of placebo (sterile 0.9% saline) on Day 1 and Day 29.

    Serious adverse events
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cohort 0 (18 to 50 years): Ad26.RSV.preF Cohort 0 (18 to 50 years): Placebo Cohort 1 (12 to 24 months): Ad26.RSV.preF Cohort 1 (12 to 24 months): Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    1 / 4 (25.00%)
    19 / 24 (79.17%)
    10 / 12 (83.33%)
    Investigations
    Heart Rate Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza B Virus Test Positive
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphocyte Count Decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory Syncytial Virus Test Positive
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    2 / 24 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    1
    Rales
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Respiratory Tract Irritation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    Rhonchi
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Allergy to Animal
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Loss of Consciousness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Irritability
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    3
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Gastritis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Teething
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    3
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Diaper
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Miliaria
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Anal Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Body Tinea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Enterovirus Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Otitis Externa
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Otitis Media
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    4 / 24 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    4 / 24 (16.67%)
    4 / 12 (33.33%)
         occurrences all number
    0
    0
    4
    5
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Skin Bacterial Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 4 (0.00%)
    8 / 24 (33.33%)
    1 / 12 (8.33%)
         occurrences all number
    3
    0
    9
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 24 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2018
    The second amendment was made to increase the number of seropositive toddlers by 12 to generate additional safety data; to specify postvaccination monitoring time; and to correct minor changes, clarifications, and corrections made throughout the protocol.
    14 Nov 2018
    The third amendment was made to change the enzyme immunoassay (EIA) cut-off criterion for seropositivity to titers >10 EIA units and to allow enrollment of respiratory syncytial virus (RSV) seropositive toddlers who have been screened for a different clinical study of the sponsor if RSV seropositivity was determined using the RSV EIA or virus neutralization assay, to potentially aid recruitment in the study.
    18 Apr 2019
    The fourth amendment was made to reduce the overall number of RSV-seropositive 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.
    Conclusions on the magnitude of the cellular immune response should be drawn with caution considering the small sample size.
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