Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children with Sickle Cell Disease (PNEU-SICKLE)

    Summary
    EudraCT number
    		 2018-001152-35
    Trial protocol
    		 GR   IT  
    Global end of trial date
    08 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2021
    First version publication date
    25 Apr 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-023
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03731182
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    05 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 17
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    Dominican Republic: 22
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Panama: 15
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    104
    EEA total number of subjects
    11
    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)
    57
    Adolescents (12-17 years)
    47
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study enrolled children with sickle cell disease. Other inclusion criteria applied.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal capsular polysaccharide with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

    Arm title
    		 Prevnar 13™
    Arm description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent pneumococcal capsular polysaccharide with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    70
    34
    V114 or Prevnar 13™ vaccination (Day 1)
    69
    34
    Completed
    65
    34
    Not completed
    5
    0
         Physician decision
    1
    -
         Withdrawal By Parent/Guardian
    2
    -
         Lost to follow-up
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 70 34 104
    Age Categorical
    Units: Participants
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 38 19 57
        Adolescents (12-17 years)
    		 32 15 47
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.8 ± 3.5 10.8 ± 3.3 -
    Gender Categorical
    Units: Participants
        Female
    		 33 14 47
        Male
    		 37 20 57
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 9 3 12
        Black or African American
    		 38 25 63
        Multiple
    		 13 4 17
        White
    		 10 2 12
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 44 24 68
        Not Hispanic or Latino
    		 26 10 36

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

    Primary: Percentage of Participants with a Solicited Injection-site Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Solicited Injection-site Adverse Event [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Up to 14 days post-vaccination
    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: There were no pre-defined between-group statistical analyses for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: Percentage of participants
    number (confidence interval 95%)
        Injection site erythema
    4.3 (0.9 to 12.2)
    5.9 (0.7 to 19.7)
        Injection site induration
    8.7 (3.3 to 18.0)
    8.8 (1.9 to 23.7)
        Injection site pain
    60.9 (48.4 to 72.4)
    67.6 (49.5 to 82.6)
        Injection site swelling
    27.5 (17.5 to 39.6)
    35.3 (19.7 to 53.5)
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event [2]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts). The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Up to 14 days post-vaccination
    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: There were no pre-defined between-group statistical analyses for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: Percentage of participants
    number (confidence interval 95%)
        Arthralgia
    2.9 (0.4 to 10.1)
    8.8 (1.9 to 23.7)
        Fatigue
    13.0 (6.1 to 23.3)
    20.6 (8.7 to 37.9)
        Headache
    24.6 (15.1 to 36.5)
    17.6 (6.8 to 34.5)
        Myalgia
    23.2 (13.9 to 34.9)
    11.8 (3.3 to 27.5)
        Urticaria
    0.0 (0.0 to 5.2)
    2.9 (0.1 to 15.3)
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Vaccine-related Serious Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event [3]
    End point description
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Up to 6 months post-vaccination
    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: There were no pre-defined between-group statistical analyses for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 5.2)
    0.0 (0.0 to 10.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30

    		 Close Top of page
    End point title
    		 Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 [4]
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. The analysis population included all randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses.
    End point type
    Primary
    End point timeframe
    Day 30
    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: There were no pre-defined between-group statistical analyses for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=66, 32)
    2.12 (1.63 to 2.75)
    2.76 (1.95 to 3.91)
        Serotype 3 (n=66, 31)
    1.09 (0.87 to 1.38)
    1.07 (0.70 to 1.65)
        Serotype 4 (n=66, 31)
    1.58 (1.18 to 2.10)
    2.90 (2.00 to 4.20)
        Serotype 5 (n=66, 31)
    4.44 (3.19 to 6.17)
    6.56 (4.09 to 10.52)
        Serotype 6A (n=66, 31)
    23.29 (17.22 to 31.52)
    15.97 (8.82 to 28.91)
        Serotype 6B (n=66, 31)
    38.38 (28.53 to 51.64)
    22.94 (13.60 to 38.71)
        Serotype 7F (n=66, 32)
    5.81 (4.42 to 7.64)
    4.65 (3.06 to 7.06)
        Serotype 9V (n=66, 32)
    4.46 (3.44 to 5.78)
    5.36 (3.45 to 8.33)
        Serotype 14 (n=66, 31)
    16.03 (11.23 to 22.90)
    20.53 (12.39 to 34.03)
        Serotype 18C (n=66, 32)
    6.11 (4.47 to 8.35)
    4.20 (2.66 to 6.62)
        Serotype 19A (n=66, 32)
    19.86 (14.77 to 26.70)
    21.65 (14.45 to 32.44)
        Serotype 19F (n=66, 32)
    13.88 (9.96 to 19.35)
    12.80 (9.10 to 18.01)
        Serotype 23F (n=63, 31)
    5.38 (3.88 to 7.46)
    6.88 (4.01 to 11.83)
        Serotype 22F (n=66, 30)
    7.30 (5.68 to 9.36)
    0.49 (0.33 to 0.73)
        Serotype 33F (n=66, 32)
    4.46 (3.38 to 5.87)
    0.97 (0.62 to 1.51)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30

    		 Close Top of page
    End point title
    		 Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
    End point description
    Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA). The analysis population included all randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: 1/dil
    geometric mean (confidence interval 95%)
        Serotype 1 (n=51, 22)
    484.0 (327.5 to 715.4)
    504.0 (254.8 to 997.0)
        Serotype 3 (n=51, 22)
    264.8 (193.4 to 362.4)
    234.3 (133.0 to 412.6)
        Serotype 4 (n=51, 22)
    4670.8 (2965.9 to 7355.6)
    7015.5 (3994.0 to 12322.6)
        Serotype 5 (n=51, 22)
    1383.9 (957.1 to 2000.9)
    1198.2 (638.1 to 2250.0)
        Serotype 6A (n=50, 22)
    27305.7 (19797.6 to 37661.2)
    20277.1 (11740.2 to 35021.7)
        Serotype 6B (n=51, 22)
    31560.4 (24134.1 to 41272.1)
    18531.0 (11024.7 to 31148.1)
        Serotype 7F (n=51, 22)
    19411.5 (15195.9 to 24796.5)
    16928.1 (11107.4 to 25799.0)
        Serotype 9V (n=51, 22)
    4561.8 (3240.7 to 6421.4)
    3941.7 (2659.6 to 5841.7)
        Serotype 14 (n=51, 22)
    6597.6 (4706.8 to 9248.0)
    8112.2 (4827.2 to 13632.8)
        Serotype 18C (n=50, 22)
    9684.6 (6642.1 to 14120.7)
    5685.1 (3329.4 to 9707.6)
        Serotype 19A (n=51, 22)
    14067.7 (9972.8 to 19843.9)
    9224.9 (5015.5 to 16967.1)
        Serotype 19F (n=51, 22)
    4931.8 (3387.8 to 7179.7)
    3313.3 (2039.4 to 5383.1)
        Serotype 23F (n=50, 22)
    17190.9 (12066.0 to 24492.4)
    19197.1 (10511.1 to 35061.1)
        Serotype 22F (n=51, 19)
    7257.5 (5278.5 to 9978.3)
    1013.2 (477.4 to 2150.1)
        Serotype 33F (n=51, 22)
    24013.6 (17612.4 to 32741.4)
    4824.8 (3216.3 to 7237.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG from Day 1 (Baseline) to Day 30

    		 Close Top of page
    End point title
    		 Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG from Day 1 (Baseline) to Day 30
    End point description
    IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination). The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of these immunogenicity analyses and who had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (n=66, 30)
    6.2 (4.6 to 8.5)
    6.0 (3.7 to 9.9)
        Serotype 3 (n=66, 29)
    4.8 (3.5 to 6.6)
    4.1 (2.6 to 6.7)
        Serotype 4 (n=66, 29)
    6.0 (4.3 to 8.3)
    9.3 (5.4 to 16.2)
        Serotype 5 (n=66, 29)
    5.3 (3.8 to 7.4)
    6.4 (3.8 to 10.8)
        Serotype 6A (n=66, 29)
    54.7 (37.9 to 78.9)
    40.6 (22.9 to 71.9)
        Serotype 6B (n=66, 29)
    37.2 (25.8 to 53.6)
    25.0 (13.8 to 45.3)
        Serotype 7F (n=66, 30)
    11.6 (8.3 to 16.0)
    9.8 (6.3 to 15.3)
        Serotype 9V (n=66, 30)
    7.4 (5.3 to 10.3)
    8.1 (4.9 to 13.2)
        Serotype 14 (n=65, 29)
    10.8 (6.8 to 17.2)
    7.2 (3.5 to 14.8)
        Serotype 18C (n=66, 30)
    10.8 (7.7 to 15.1)
    7.6 (4.5 to 12.8)
        Serotype 19A (n=66, 30)
    8.2 (5.4 to 12.4)
    8.6 (5.0 to 14.9)
        Serotype 19F (n=66, 30)
    8.3 (5.6 to 12.3)
    7.6 (4.5 to 12.8)
        Serotype 23F (n=63, 29)
    9.3 (6.1 to 14.2)
    13.1 (7.4 to 23.4)
        Serotype 22F (n=66, 28)
    15.0 (10.1 to 22.1)
    1.1 (0.9 to 1.3)
        Serotype 33F (n=66, 30)
    9.0 (6.7 to 12.1)
    1.3 (1.0 to 1.7)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific OPA from Day 1 (Baseline) to Day 30

    		 Close Top of page
    End point title
    		 GMFR in Serotype-specific OPA from Day 1 (Baseline) to Day 30
    End point description
    Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination). The analysis population included all randomized participants without protocol deviations that could have substantially affected the results of these immunogenicity analyses and who had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    69
    34
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (n=49, 20)
    24.1 (14.9 to 39.1)
    13.3 (5.1 to 34.2)
        Serotype 3 (n=50, 21)
    4.9 (3.5 to 7.0)
    3.1 (1.8 to 5.6)
        Serotype 4 (n=49, 21)
    10.2 (6.3 to 16.6)
    18.5 (8.8 to 38.9)
        Serotype 5 (n=49, 21)
    23.7 (15.0 to 37.5)
    13.8 (6.6 to 28.6)
        Serotype 6A (n=47, 21)
    20.7 (13.3 to 32.1)
    11.2 (4.8 to 26.2)
        Serotype 6B (n=47, 19)
    21.7 (12.7 to 36.9)
    13.7 (6.8 to 27.7)
        Serotype 7F (n=50, 21)
    5.4 (3.8 to 7.7)
    5.4 (3.2 to 9.1)
        Serotype 9V (n=48, 20)
    4.4 (3.0 to 6.5)
    6.1 (3.6 to 10.4)
        Serotype 14 (n=50, 21)
    6.9 (4.3 to 11.1)
    4.6 (2.1 to 10.2)
        Serotype 18C (n=45, 20)
    14.0 (8.9 to 22.0)
    4.8 (2.5 to 9.3)
        Serotype 19A (n=50, 21)
    9.0 (5.4 to 15.0)
    7.8 (4.4 to 14.0)
        Serotype 19F (n=50, 20)
    6.4 (4.3 to 9.7)
    6.6 (3.3 to 12.9)
        Serotype 23F (n=48, 20)
    10.4 (5.8 to 18.4)
    18.1 (8.8 to 37.1)
        Serotype 22F (n=48, 17)
    6.5 (3.7 to 11.3)
    0.9 (0.7 to 1.2)
        Serotype 33F (n=50, 21)
    3.8 (2.7 to 5.2)
    0.8 (0.7 to 1.0)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs: up to 14 days post-vaccination; serious AEs and deaths (all causes): up to 6 months post-vaccination
    Adverse event reporting additional description
    The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for number of deaths (all causes) included all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Prevnar 13
    Reporting group description
    		 -

    Reporting group title
    V114
    Reporting group description
    		 -

    Serious adverse events
    		 Prevnar 13 V114
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 34 (23.53%)
    13 / 69 (18.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Medical observation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    6 / 34 (17.65%)
    7 / 69 (10.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute chest syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prevnar 13 V114
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 34 (79.41%)
    52 / 69 (75.36%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 34 (17.65%)
    17 / 69 (24.64%)
         occurrences all number
    10
    25
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 34 (20.59%)
    9 / 69 (13.04%)
         occurrences all number
    7
    9
    Injection site erythema
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 69 (4.35%)
         occurrences all number
    2
    3
    Injection site induration
         subjects affected / exposed
    3 / 34 (8.82%)
    6 / 69 (8.70%)
         occurrences all number
    3
    6
    Injection site pain
         subjects affected / exposed
    23 / 34 (67.65%)
    42 / 69 (60.87%)
         occurrences all number
    25
    48
    Injection site swelling
         subjects affected / exposed
    12 / 34 (35.29%)
    19 / 69 (27.54%)
         occurrences all number
    14
    21
    Pyrexia
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 69 (5.80%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 69 (2.90%)
         occurrences all number
    4
    3
    Back pain
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 69 (5.80%)
         occurrences all number
    1
    4
    Myalgia
         subjects affected / exposed
    4 / 34 (11.76%)
    16 / 69 (23.19%)
         occurrences all number
    7
    20

    More information

    		 Close Top of page

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 03:56:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA