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   43865   clinical trials with a EudraCT protocol, of which   7286   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 Single-blind, Randomized, Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants

    Summary
    EudraCT number
    		 2008-001457-18
    Trial protocol
    		 ES  
    Global end of trial date
    02 Mar 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    29 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6108K2-2000
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00798304
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1971008
    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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. To assess the immunogenicity of 60 microgram (mcg), 120 mcg, and 200 mcg of recombinant lipoprotein 2086 (rLP2086) as measured by serum bactericidal assay (SBA) to meningococcal serogroup B (MnB) strains expressing LP2086 subfamily A and B proteins in healthy infants 1 month after the infant series. 2. To assess the safety and tolerability of 20 mcg, 60 mcg, 120 mcg, and 200 mcg of rLP2086 when given with routine childhood vaccines in healthy infants and toddlers.
    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 Conference on 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
    09 Jan 2009
    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
    Spain: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    46
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 In this study, subjects were to receive rLP2086 vaccine at 2, 4, 6 and 12 months of age. Due to premature termination of study, only single dose of 20 or 60 mcg of rLP2086 vaccine was administered at 2 months and planned treatments of rLP2086 vaccine 120 mcg and 200 mcg were not administered.

    Pre-assignment
    Screening details
    		 A total of 744 subjects were planned to be enrolled in this study. Of which 46 subjects were randomized and assigned to treatment.

    Period 1
    Period 1 title
    Stage 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    InfanrixHexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received InfanrixHexa at 2 months of age.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Meningococcal Serogroup C vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Meningococcal Serogroup C vaccine at 2 months of age.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pneumococcal Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 milliliter (mL) of Prevenar at 2 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Rotarix at 2 months of age.

    Arm title
    		 rLP2086 20 mcg
    Arm description
    		 rLP2086 20 mcg vaccine along with routine childhood vaccines according to local practice.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Recombinant lipoprotein 2086
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single 20 mcg dose of rLP2086.

    Investigational medicinal product name
    InfanrixHexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received InfanrixHexa at 2 months of age.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Meningococcal Serogroup C vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Meningococcal Serogroup C vaccine at 2 months of age.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pneumococcal Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 milliliter (mL) of Prevenar at 2 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Rotarix at 2 months of age.

    Arm title
    		 rLP2086 60 mcg
    Arm description
    		 rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Recombinant lipoprotein 2086
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single 60 mcg dose of rLP2086.

    Investigational medicinal product name
    InfanrixHexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received InfanrixHexa at 2 months of age.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Meningococcal Serogroup C vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Meningococcal Serogroup C vaccine at 2 months of age.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pneumococcal Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 milliliter (mL) of Prevenar at 2 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Rotarix at 2 months of age.

    Number of subjects in period 1
    		Control rLP2086 20 mcg rLP2086 60 mcg
    Started
    14
    22
    10
    Completed
    0
    0
    0
    Not completed
    14
    22
    10
         Adverse Event
    -
    1
    1
         Discontinuation by Sponsor
    14
    21
    9

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.

    Reporting group title
    rLP2086 20 mcg
    Reporting group description
    		 rLP2086 20 mcg vaccine along with routine childhood vaccines according to local practice.

    Reporting group title
    rLP2086 60 mcg
    Reporting group description
    		 rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.

    Reporting group values
    		 Control rLP2086 20 mcg rLP2086 60 mcg Total
    Number of subjects
    		 14 22 10 46
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 63.6 ± 11.57 64 ± 10.02 71.6 ± 11.35 -
    Gender categorical
    Units: Subjects
        Female
    		 6 12 4 22
        Male
    		 8 10 6 24

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.

    Reporting group title
    rLP2086 20 mcg
    Reporting group description
    		 rLP2086 20 mcg vaccine along with routine childhood vaccines according to local practice.

    Reporting group title
    rLP2086 60 mcg
    Reporting group description
    		 rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.

    Primary: Percentage of Subjects Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain [1]
    End point description
    Percentage of Subjects Achieving at Least 1:4 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain. Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Primary
    End point timeframe
    1 month after Dose 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was done since no descriptive data was collected due to early study termination.
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [2] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [3] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [4] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least One Adverse Event (AE)

    		 Close Top of page
    End point title
    		 Percentage of Subjects With at Least One Adverse Event (AE) [5]
    End point description
    The Safety population included all subjects who have received at least 1 dose of the investigational vaccine.
    End point type
    Primary
    End point timeframe
    From signing of informed consent form to completion of study (up to 2 years)
    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: No statistical analysis have been specified as descriptive statistic was planned.
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    14
    22
    10
    Units: percentage of subjects
        number (not applicable)
    21.4
    31.8
    20
    No statistical analyses for this end point

    Secondary: Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain

    		 Close Top of page
    End point title
    		 Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
    End point description
    Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Secondary
    End point timeframe
    1 month after Dose 2, Dose 3; before Dose 4
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [6] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [7] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [8] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
    End point description
    Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Secondary
    End point timeframe
    1 month after Dose 2, Dose 3; before Dose 4
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [9] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [10] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [11] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer
    End point description
    Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Other pre-specified
    End point timeframe
    1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [12] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [13] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [14] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains
    End point description
    Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Other pre-specified
    End point timeframe
    1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [15] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [16] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [17] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Other pre-specified: Serum Bactericidal Assay (SBA) Geometirc Mean Titers (GMTs) for Additional MnB Test Strains

    		 Close Top of page
    End point title
    		 Serum Bactericidal Assay (SBA) Geometirc Mean Titers (GMTs) for Additional MnB Test Strains
    End point description
    Results were not reported, as no immunogenicity data was collected due to study termination prior to first post vaccination blood draw.
    End point type
    Other pre-specified
    End point timeframe
    1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
    End point values
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: titer
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [18] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [19] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    [20] - Immunogenicity data was not collected as study was terminated prior to first scheduled blood draw.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent form till study termination
    Adverse event reporting additional description
    Version was not captured, here 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.

    Reporting group title
    rLP2086 20 mcg
    Reporting group description
    		 rLP2086 20 mcg vaccine along with routine childhood vaccines according to local practice.

    Reporting group title
    rLP2086 60 mcg
    Reporting group description
    		 rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.

    Serious adverse events
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 22 (18.18%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 22 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control rLP2086 20 mcg rLP2086 60 mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 22 (18.18%)
    2 / 10 (20.00%)
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0

    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.
    Immunogenicity results were not reported because the study was terminated due to the reactogenicity profile of the vaccine in infants prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
    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 26 20:06:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA