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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59-years, Including Those at High-risk for Severe RSV

    Summary
    EudraCT number
    		 2021-001909-77
    Trial protocol
    		 DE   BE   ES  
    Global end of trial date
    12 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2023
    First version publication date
    27 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR109038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05070546
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V
    Sponsor organisation address
    4-6, Archimedesweg, Leiden, Netherlands, 2333
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V, clinicaltrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate safety and reactogenicity of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) based respiratory syncytial virus (RSV) vaccine in healthy and high-risk adults aged 18 to 59 years; to demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in adults aged 18 to 59 years versus in adults aged 65 years and older and If non-inferiority was demonstrated in adults: to demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in high-risk adults aged 18 to 59 years versus in adults aged 65 years and older in whom efficacy of the vaccine was demonstrated.
    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
    29 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 278
    Country: Number of subjects enrolled
    Germany: 312
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Sweden: 277
    Country: Number of subjects enrolled
    United States: 231
    Worldwide total number of subjects
    1118
    EEA total number of subjects
    887
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    775
    From 65 to 84 years
    342
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 1124 subjects were enrolled and randomized. Of these, 6 subjects discontinued the study prior to receiving study vaccination. Therefore, 1118 subjects were included in the analysis.

    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
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein
    Arm description
    		 Healthy adult subjects aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF and RSV preF protein
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received mixture of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and respiratory syncytial virus preF virus prefusion F‐protein (RSV preF protein) 150 micrograms (mcg) on Day 1.

    Arm title
    		 Group 2 (Cohort 1): Placebo
    Arm description
    		 Healthy adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
    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
    Subjects received matching placebo on Day 1.

    Arm title
    		 Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Arm description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF and RSV preF protein
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Arm title
    		 Group 4 (Cohort 2): Placebo
    Arm description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
    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
    Subjects received matching placebo on Day 1.

    Arm title
    		 Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein
    Arm description
    		 Adult subjects aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF and RSV preF protein
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Arm title
    		 Group 6 (Cohort 3): Placebo
    Arm description
    		 Adult subjects aged 65 years and older received a single IM injection of matching placebo on Day 1.
    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
    Subjects received matching placebo on Day 1.

    Number of subjects in period 1
    		Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 6 (Cohort 3): Placebo
    Started
    319
    68
    319
    69
    313
    30
    Completed
    310
    65
    309
    68
    308
    29
    Not completed
    9
    3
    10
    1
    5
    1
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    1
         Consent withdrawn by subject
    1
    1
    3
    -
    -
    -
         Unspecified
    -
    -
    -
    -
    3
    -
         Lost to follow-up
    8
    2
    7
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.

    Reporting group title
    Group 2 (Cohort 1): Placebo
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.

    Reporting group title
    Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Reporting group title
    Group 4 (Cohort 2): Placebo
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.

    Reporting group title
    Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 Adult subjects aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Reporting group title
    Group 6 (Cohort 3): Placebo
    Reporting group description
    		 Adult subjects aged 65 years and older received a single IM injection of matching placebo on Day 1.

    Reporting group values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 6 (Cohort 3): Placebo Total
    Number of subjects
    		 319 68 319 69 313 30 1118
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 319 68 319 69 0 0 775
        From 65-84 years
    		 0 0 0 0 312 30 342
        85 years and over
    		 0 0 0 0 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.8 ± 12.33 38.4 ± 12.34 44.4 ± 11.81 44.6 ± 11.58 71.1 ± 4.74 71.2 ± 5.1 -
    Sex: Female, Male
    Units: subjects
        Female
    		 193 40 174 39 181 21 648
        Male
    		 126 28 145 30 132 9 470
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 0 0 0 1
        Asian
    		 1 0 2 0 0 0 3
        Black or African American
    		 24 4 7 1 9 0 45
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 0 1 0 2
        White
    		 289 64 308 68 303 29 1061
        More than one race
    		 4 0 0 0 0 1 5
        Unknown or Not Reported
    		 1 0 0 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 42 10 40 9 19 2 122
        Not Hispanic or Latino
    		 274 57 276 60 289 28 984
        Unknown or Not Reported
    		 3 1 3 0 5 0 12
    Region of Enrollment
    Units: Subjects
        BELGIUM
    		 178 36 38 5 18 3 278
        GERMANY
    		 0 0 175 38 88 11 312
        SPAIN
    		 0 0 15 5 0 0 20
        SWEDEN
    		 33 8 50 15 160 11 277
        UNITED STATES
    		 108 24 41 6 47 5 231
    AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.8 ± 12.33 38.4 ± 12.34 44.4 ± 11.81 44.6 ± 11.58 71.1 ± 4.74 71.2 ± 5.1 -

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.

    Reporting group title
    Group 2 (Cohort 1): Placebo
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.

    Reporting group title
    Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Reporting group title
    Group 4 (Cohort 2): Placebo
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received a single IM injection of matching placebo on Day 1.

    Reporting group title
    Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein
    Reporting group description
    		 Adult subjects aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Reporting group title
    Group 6 (Cohort 3): Placebo
    Reporting group description
    		 Adult subjects aged 65 years and older received a single IM injection of matching placebo on Day 1.

    Subject analysis set title
    Groups 1&3: Ad26.RSV.preF and RSV preF protein
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy (Group 1) and high-risk adult (Group 3) subjects aged 18 to 59 years received intramuscular (IM) injection containing mixture of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and respiratory syncytial virus prefusion F‐protein (RSV preF protein) 150 micrograms (mcg) on Day 1.

    Subject analysis set title
    Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Adult subjects aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Subject analysis set title
    Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    High-risk adult subjects aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Primary: Cohorts 1 and 2: Number of Subjects with Solicited Local Adverse Events (AEs)

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    End point title
    		 Cohorts 1 and 2: Number of Subjects with Solicited Local Adverse Events (AEs) [1] [2]
    End point description
    Number of subjects with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. Full analysis set (FAS) included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint. This endpoint was planned to be analysed for specified cohorts only.
    End point type
    Primary
    End point timeframe
    7 days after vaccination on Day 1 (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: Endpoint was planned to be analyzed for specified arms only.
    [2] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo
    Number of subjects analysed
    316
    68
    318
    68
    Units: subjects
    273
    10
    276
    15
    No statistical analyses for this end point

    Primary: Cohorts 1 and 2: Number of Subjects with Solicited Systemic AEs

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    End point title
    		 Cohorts 1 and 2: Number of Subjects with Solicited Systemic AEs [3] [4]
    End point description
    Number of subjects with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a subjects participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination. FAS included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint. This endpoint was planned to be analysed for specified cohorts only.
    End point type
    Primary
    End point timeframe
    7 days after vaccination on Day 1 (Day 8)
    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: Endpoint was planned to be analyzed for specified arms only.
    [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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo
    Number of subjects analysed
    316
    68
    318
    68
    Units: subjects
    277
    33
    275
    40
    No statistical analyses for this end point

    Primary: Cohorts 1 and 2: Number of Subjects with Unsolicited AEs

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    End point title
    		 Cohorts 1 and 2: Number of Subjects with Unsolicited AEs [5] [6]
    End point description
    Number of subjects with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a subject participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the subject was not specifically questioned in the subject diary. FAS included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). This endpoint was planned to be analysed for specified cohorts only.
    End point type
    Primary
    End point timeframe
    28 days after vaccination on Day 1 (Day 29)
    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: Endpoint was planned to be analyzed for specified arms only.
    [6] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo
    Number of subjects analysed
    319
    68
    319
    69
    Units: subjects
    111
    13
    85
    12
    No statistical analyses for this end point

    Primary: Cohorts 1 and 2: Number of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Cohorts 1 and 2: Number of Subjects with Serious Adverse Events (SAEs) [7]
    End point description
    Number of subjects with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a subject administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize subject and/or required medical or surgical intervention to prevent one of the outcomes listed above. FAS included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
    End point type
    Primary
    End point timeframe
    6 months after vaccination on Day 1 (Day 183)
    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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 6 (Cohort 3): Placebo
    Number of subjects analysed
    319
    68
    319
    69
    313
    30
    Units: subjects
    1
    1
    10
    0
    13
    1
    No statistical analyses for this end point

    Primary: Cohorts 1 and 2: Number of Subjects with Adverse Events of Special Interest (AESI)

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    End point title
    		 Cohorts 1 and 2: Number of Subjects with Adverse Events of Special Interest (AESI) [8]
    End point description
    Number of subjects with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI. FAS included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
    End point type
    Primary
    End point timeframe
    6 months after vaccination on Day 1 (Day 183)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 6 (Cohort 3): Placebo
    Number of subjects analysed
    319
    68
    319
    69
    313
    30
    Units: subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers

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    End point title
    		 Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
    End point description
    RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units. The Per-protocol Immunogenicity (PPI) set included all randomized subjects on Day 15 who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint. This endpoint was planned to be analysed for specified arms only. As planned, combined data of subjects aged 18-59 years (in Cohort 1 (group 1) and Cohort 2 (group 3) has been reported.
    End point type
    Primary
    End point timeframe
    14 days after vaccination on Day 1 (Day 15)
    End point values
    		 Groups 1&3: Ad26.RSV.preF and RSV preF protein Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Number of subjects analysed
    602
    290
    301
    Units: Titers
        geometric mean (confidence interval 95%)
    6491 (5847 to 7206)
    4596 (4059 to 5204)
    7095 (6261 to 8042)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 [Group 5]/Cohort 1[Group1] and 2 [Group 3]).
    Comparison groups
    Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein v Groups 1&3: Ad26.RSV.preF and RSV preF protein
    Number of subjects included in analysis
    892
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.6
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 [Group 5]/Cohort 2 [Group 3]).
    Comparison groups
    Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein v Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 1.78

    Primary: Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Subjects with Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)

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    End point title
    		 Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Subjects with Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
    End point description
    Percentage of subjects with seroresponse as assessed by VNA A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA-A2 antibody titers. PPI set included all randomized subjects on Day 15 who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint. This endpoint was planned to be analysed for specified arms only. As planned, combined data of subjects aged 18-59 years (in Cohort 1 (group 1) and Cohort 2 (group 3) has been reported.
    End point type
    Primary
    End point timeframe
    14 days after vaccination on Day 1 (Day 15)
    End point values
    		 Groups 1&3: Ad26.RSV.preF and RSV preF protein Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Number of subjects analysed
    602
    290
    300
    Units: percentage of subjects
        number (not applicable)
    89.37
    82.41
    88
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 [Group 5]/Cohort 1[Group1] and 2 [Group 3]).
    Comparison groups
    Groups 1&3: Ad26.RSV.preF and RSV preF protein v Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein
    Number of subjects included in analysis
    892
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Difference in Seroresponse rate
    Parameter type
    		 Difference in Seroresponse rate
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 10.9
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 [Group 5]/Cohort 2 [Group 3]).
    Comparison groups
    Arm: Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein v Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein
    Number of subjects included in analysis
    590
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in Seroresponse rate
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 10.5

    Secondary: Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion

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    End point title
    		 Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
    End point description
    GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported. PPI set included all randomized subjects on Day 15 who received study vaccine and for whom immunogenicity data were available.
    End point type
    Secondary
    End point timeframe
    14 days after vaccination on Day 1 (Day 15)
    End point values
    		 Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF protein Group 2 (Cohort 1): Placebo Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF protein Group 4 (Cohort 2): Placebo Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF protein Group 6 (Cohort 3): Placebo
    Number of subjects analysed
    302
    64
    301
    61
    290
    29
    Units: ELISA Units/Litre (EU/L)
        geometric mean (confidence interval 95%)
    4662 (4350 to 4997)
    246 (214 to 284)
    5175 (4808 to 5569)
    283 (246 to 326)
    3864 (3559 to 4196)
    240 (203 to 285)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 183
    Adverse event reporting additional description
    Full analysis set included all subjects who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Cohort 1: Ad26.RSV.preF and RSV preF protein (Group 1)
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received intramuscular (IM) injection containing mixture of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and respiratory syncytial virus prefusion F‐protein (RSV preF protein) 150 micrograms (mcg) on Day 1.

    Reporting group title
    Cohort 1: Placebo (Group 2)
    Reporting group description
    		 Healthy adult subjects aged 18 to 59 years received IM injection of matching placebo on Day 1.

    Reporting group title
    Cohort 3: Placebo (Group 6)
    Reporting group description
    		 Adult subjects aged 65 years and older received IM injection of matching placebo on Day 1 of vaccination.

    Reporting group title
    Cohort 2: Placebo (Group 4)
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received IM injection of matching placebo on Day 1.

    Reporting group title
    Cohort 3: Ad26.RSV.preF and RSV preF protein (Group 5)
    Reporting group description
    		 Adult subjects aged 65 years and older received IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Reporting group title
    Cohort 2: Ad26.RSV.preF and RSV preF protein (Group 3)
    Reporting group description
    		 High-risk adult subjects aged 18 to 59 years received IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Serious adverse events
    		 Cohort 1: Ad26.RSV.preF and RSV preF protein (Group 1) Cohort 1: Placebo (Group 2) Cohort 3: Placebo (Group 6) Cohort 2: Placebo (Group 4) Cohort 3: Ad26.RSV.preF and RSV preF protein (Group 5) Cohort 2: Ad26.RSV.preF and RSV preF protein (Group 3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 319 (0.31%)
    1 / 68 (1.47%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    13 / 313 (4.15%)
    10 / 319 (3.13%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Cancer Stage 0, with Cancer in Situ
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Her2 Positive Breast Cancer
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius Fracture
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic Fracture
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Facial Paresis
         subjects affected / exposed
    1 / 319 (0.31%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular Torsion
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    2 / 313 (0.64%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic Fever with Renal Syndrome
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    1 / 313 (0.32%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 319 (0.00%)
    1 / 68 (1.47%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    0 / 319 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis Aseptic
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Cohort 1: Ad26.RSV.preF and RSV preF protein (Group 1) Cohort 1: Placebo (Group 2) Cohort 3: Placebo (Group 6) Cohort 2: Placebo (Group 4) Cohort 3: Ad26.RSV.preF and RSV preF protein (Group 5) Cohort 2: Ad26.RSV.preF and RSV preF protein (Group 3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 319 (24.14%)
    5 / 68 (7.35%)
    5 / 30 (16.67%)
    8 / 69 (11.59%)
    32 / 313 (10.22%)
    50 / 319 (15.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 319 (1.25%)
    4 / 68 (5.88%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    2 / 313 (0.64%)
    2 / 319 (0.63%)
         occurrences all number
    4
    4
    0
    0
    2
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    60 / 319 (18.81%)
    1 / 68 (1.47%)
    0 / 30 (0.00%)
    1 / 69 (1.45%)
    15 / 313 (4.79%)
    31 / 319 (9.72%)
         occurrences all number
    60
    1
    0
    1
    15
    31
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    0 / 319 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 319 (0.63%)
    1 / 68 (1.47%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    2 / 313 (0.64%)
    2 / 319 (0.63%)
         occurrences all number
    2
    1
    1
    0
    2
    2
    Vomiting
         subjects affected / exposed
    8 / 319 (2.51%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    2 / 313 (0.64%)
    2 / 319 (0.63%)
         occurrences all number
    8
    0
    0
    0
    2
    2
    Skin and subcutaneous tissue disorders
    Night Sweats
         subjects affected / exposed
    8 / 319 (2.51%)
    0 / 68 (0.00%)
    0 / 30 (0.00%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences all number
    8
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle Spasms
         subjects affected / exposed
    0 / 319 (0.00%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    8 / 319 (2.51%)
    1 / 68 (1.47%)
    1 / 30 (3.33%)
    3 / 69 (4.35%)
    2 / 313 (0.64%)
    4 / 319 (1.25%)
         occurrences all number
    8
    1
    1
    3
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    1 / 319 (0.31%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    3 / 69 (4.35%)
    9 / 313 (2.88%)
    9 / 319 (2.82%)
         occurrences all number
    1
    0
    1
    3
    9
    9
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 319 (0.94%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    3 / 69 (4.35%)
    1 / 313 (0.32%)
    1 / 319 (0.31%)
         occurrences all number
    3
    0
    1
    3
    1
    1
    Sinusitis
         subjects affected / exposed
    7 / 319 (2.19%)
    0 / 68 (0.00%)
    1 / 30 (3.33%)
    0 / 69 (0.00%)
    0 / 313 (0.00%)
    1 / 319 (0.31%)
         occurrences all number
    7
    0
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2021
    The purpose of this amendment was to include the addition of seroresponse rates in addition to neutralizing antibody geoemtric mean titers (GMTs) as primary endpoints to evaluate non-inferiority of immune responses. The primary immunogenicity endpoint was also modified from respiratory syncytial virus prefusion F‐protein (RSV preF protein) imuunoglobulin (IgG) (by enzyme-linked immunosorbent assay [ELISA]) to a functional immune marker (anti-RSV virus neutralizing antibodies). The statistical hypotheses and success criteria were revised accordingly, resulting also in a change in sample size and randomization ratios.
    30 Nov 2021
    The purpose of this amendment was to include provision of additional guidance in the appendix to the protocol for inclusion of participants in Cohort 2, with examples of chronic cardiac and pulmonary comorbidities eligible for participation in this cohort. Furthermore, additional language referring to laboratory diagnostic tests for the follow-up and assessment of potential adverse event of special interests (AESIs) was added.

    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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    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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