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    Clinical Trial Results:
    A Phase 4, Open-Label, Single-Arm, Multicenter Study to Describe the Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children 6 to 17 Years of Age in India

    Summary
    EudraCT number
    		 2019-000890-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2019
    First version publication date
    01 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1851190
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03777865
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of 13-Valent Pneumococcal Conjugate (13vPnC) in pediatric subjects 6 to 17 years of age.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    73
    Adolescents (12-17 years)
    27
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted in 1 country from 14 December 2018 to 17 April 2019. A total of 100 subjects were enrolled.

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

    Arms
    Arm title
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Arm description
    		 Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13-valent Pneumococcal Conjugate Vaccine
    Investigational medicinal product code
    13vPnC
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of 0.5 mL of 13vPnC vaccine as intramuscularly on Day 1.

    Number of subjects in period 1
    		13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Started
    100
    Completed
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Reporting group description
    		 Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.

    Reporting group values
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine Total
    Number of subjects
    		 100 100
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.28 ( 2.985 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 47 47
        Male
    		 53 53
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 100 100
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 0 0
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 100 100
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Reporting group description
    		 Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.

    Primary: Percentage of Subjects Reporting Local Reactions by Severity Within 7 Days After Vaccination

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    End point title
    		 Percentage of Subjects Reporting Local Reactions by Severity Within 7 Days After Vaccination [1]
    End point description
    Local reactions (redness, swelling and pain [tenderness]) at the 13vPnC injection site were monitored daily for 7 days after vaccination. Redness and swelling were measured and recorded in a measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as; any (any redness or swelling at the injection site), mild (1 to 4 measuring device units = 0.5 to 2.0 cm), moderate (5 to 14 measuring device units = 2.5 to 7.0 cm) and severe (greater than [>]14 measuring device units = >7.0 cm). Pain (tenderness) at injection site was categorized as; any: any pain at the injection site, mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. The safety population included all subjects who received 1 dose of an investigational product. Here, “Number of Subjects Analyzed”(N)=subjects evaluable for this end point and “n”=subjects evaluable at specific rows.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination on Day 1 (up to Day 7)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was analyzed for this endpoint.
    End point values
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Number of subjects analysed
    92
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any (n= 74)
    14.9 (7.7 to 25.0)
        Redness: Mild (n= 74)
    14.9 (7.7 to 25.0)
        Redness: Moderate (n= 74)
    0 (0.0 to 4.9)
        Redness: Severe (n= 74)
    0 (0.0 to 4.9)
        Swelling: Any (n= 74)
    17.6 (9.7 to 28.2)
        Swelling: Mild (n= 74)
    17.6 (9.7 to 28.2)
        Swelling: Moderate (n= 74)
    0 (0.0 to 4.9)
        Swelling: Severe (n= 74)
    0 (0.0 to 4.9)
        Pain: Any (n= 91)
    67.0 (56.4 to 76.5)
        Pain: Mild (n= 91)
    45.1 (34.6 to 55.8)
        Pain: Moderate (n= 91)
    19.8 (12.2 to 29.4)
        Pain: Severe (n= 91)
    2.2 (0.3 to 7.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Systemic Events by Severity Within 7 Days After Vaccination

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    End point title
    		 Percentage of Subjects Reporting Systemic Events by Severity Within 7 Days After Vaccination [2]
    End point description
    Systemic events included fever, fatigue(tiredness), headache, muscle pain, joint pain, vomiting and diarrhea. Fever: greater than or equal to (>=) 38.0 degrees Celsius (C), >=38.0 degrees C to <=38.4 degrees C, >=38.5 to <=38.9 degrees C, 39.0 to 40.0 degrees C, > 40.0 degrees C. Fatigue, headache, muscle pain and joint pain graded as any (any fatigue, headache, muscle pain, joint pain), mild(did not interfere with activity), moderate(some interference with activity) or severe(prevented daily routine activity). Vomiting was graded as any (any vomiting), mild (1-2 times in 24 hours [hrs.]), moderate(>2 times in 24 hrs.) or severe (required intravenous hydration). Diarrhea was graded as any(any diarrhea), mild (2-3 loose stools in 24 hrs.), moderate(4-5 loose stools in 24 hrs.) or severe(>=6 loose stools in 24 hrs.). The safety population=all subjects who received 1 dose of an investigational product. “N”=subjects evaluable for this end point; “n”=subjects evaluable at specific rows.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination on Day 1 (up to Day 7)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was analyzed for this endpoint.
    End point values
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Number of subjects analysed
    83
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n=73)
    4.1 (0.9 to 11.5)
        Fever: >=38 degrees C to <=38.4 degrees C (n= 73)
    1.4 (0.0 to 7.4)
        Fever:>=38.5 degrees C to <=38.9 degrees C (n=73)
    2.7 (0.3 to 9.5)
        Fever:>=39.0 degrees C to <=40.0 degrees C (n=73)
    0 (0.0 to 4.9)
        Fever: >40.0 degrees C (n=73)
    0 (0.0 to 4.9)
        Fatigue: Any (n= 77)
    31.2 (21.1 to 42.7)
        Fatigue: Mild (n= 77)
    22.1 (13.4 to 33.0)
        Fatigue: Moderate (n= 77)
    6.5 (2.1 to 14.5)
        Fatigue: Severe (n= 77)
    2.6 (0.3 to 9.1)
        Headache: Any (n= 76)
    25.0 (15.8 to 36.3)
        Headache: Mild (n= 76)
    15.8 (8.4 to 26.0)
        Headache: Moderate (n= 76)
    6.6 (2.2 to 14.7)
        Headache: Severe (n= 76)
    2.6 (0.3 to 9.2)
        Muscle pain: Any (n= 77)
    27.3 (17.7 to 38.6)
        Muscle pain: Mild (n= 77)
    20.8 (12.4 to 31.5)
        Muscle pain: Moderate (n= 77)
    3.9 (0.8 to 11.0)
        Muscle pain: Severe (n= 77)
    2.6 (0.3 to 9.1)
        Joint pain: Any (n= 77)
    13.0 (6.4 to 22.6)
        Joint pain: Mild (n= 77)
    3.9 (0.8 to 11.0)
        Joint pain: Moderate (n= 77)
    7.8 (2.9 to 16.2)
        Joint pain: Severe (n= 77)
    1.3 (0.0 to 7.0)
        Vomiting: Any (n= 73)
    9.6 (3.9 to 18.8)
        Vomiting: Mild (n= 73)
    8.2 (3.1 to 17.0)
        Vomiting: Moderate (n= 73)
    1.4 (0.0 to 7.4)
        Vomiting: Severe (n= 73)
    0 (0.0 to 4.9)
        Diarrhea: Any (n= 73)
    4.1 (0.9 to 11.5)
        Diarrhea: Mild (n= 73)
    2.7 (0.3 to 9.5)
        Diarrhea: Moderate (n= 73)
    1.4 (0.0 to 7.4)
        Diarrhea: Severe (n= 73)
    0 (0.0 to 4.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Treatment Emergent Adverse Events (AEs) and Serious adverse events (SAEs)

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    End point title
    		 Percentage of Subjects With Treatment Emergent Adverse Events (AEs) and Serious adverse events (SAEs) [3]
    End point description
    An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. Treatment-emergent were events between first dose of study drug and up to 1 month that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. The safety population included all subjects who received 1 dose of an investigational product. Here, “n”=subjects evaluable at specific rows.
    End point type
    Primary
    End point timeframe
    up to 1 month after vaccination on Day 1
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was analyzed for this endpoint.
    End point values
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Number of subjects analysed
    100
    Units: percentage of subjects
    number (confidence interval 95%)
        AEs (n=100)
    75.0 (65.3 to 83.1)
        SAEs (n=100)
    1.0 (0.0 to 5.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 1 month after vaccination on Day 1
    Adverse event reporting additional description
    Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Reporting group description
    		 Subjects received a single dose of 0.5 mL dose of 13vPnC vaccine, intramuscularly injection on Day 1.

    Serious adverse events
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 100 (75.00%)
    General disorders and administration site conditions
    Headache
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    19 / 76 (25.00%)
         occurrences all number
    19
    Fatigue
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    24 / 77 (31.17%)
         occurrences all number
    24
    Diarrhoea
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    3 / 73 (4.11%)
         occurrences all number
    3
    Vomiting
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    7 / 73 (9.59%)
         occurrences all number
    7
    Fever
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    3 / 73 (4.11%)
         occurrences all number
    3
    Muscle pain
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    21 / 77 (27.27%)
         occurrences all number
    21
    Joint pain
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    10 / 77 (12.99%)
         occurrences all number
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Redness
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    11 / 74 (14.86%)
         occurrences all number
    11
    Swelling
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    13 / 74 (17.57%)
         occurrences all number
    13
    Pain at the injection site
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    61 / 91 (67.03%)
         occurrences all number
    61
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? 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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