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Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

Primary Purpose

Pneumococcal Infection

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PNEUMOVAX™ 23
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infection

Eligibility Criteria

70 Years - 89 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Japanese participant
  • Good health or any underlying chronic illness is documented to be in stable condition
  • Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
  • Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria:
  • Known allergy or sensitivity to any of the components of the study vaccine
  • History of pneumococcal conjugate vaccination
  • Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
  • Functional or anatomic asplenia
  • Received immunoglobulin within 6 months before study vaccine or is planned during the study
  • Received any investigational drugs or vaccines within 2 months before study vaccination
  • History of pneumococcal disease (positive culture from blood or other normally sterile site)
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • History of convulsion
  • Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
  • Participating in any other clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Revaccination Group

    Primary Vaccination Group

    Arm Description

    0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior

    0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.

    Secondary Outcome Measures

    Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
    Percentage of Participants With an Adverse Event of Injection-site Erythema
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Injection-site Swelling
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Injection-site Pain
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Pyrexia
    Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Myalgia
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Arthralgia
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Headache
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.
    Percentage of Participants With an Adverse Event of Fatigue
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.

    Full Information

    First Posted
    October 6, 2014
    Last Updated
    October 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02260882
    Brief Title
    Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
    Official Title
    A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 31, 2014 (Actual)
    Primary Completion Date
    April 9, 2015 (Actual)
    Study Completion Date
    April 9, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumococcal Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    243 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Revaccination Group
    Arm Type
    Experimental
    Arm Description
    0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior
    Arm Title
    Primary Vaccination Group
    Arm Type
    Experimental
    Arm Description
    0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination
    Intervention Type
    Biological
    Intervention Name(s)
    PNEUMOVAX™ 23
    Intervention Description
    PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
    Description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
    Time Frame
    Baseline and 4 weeks after revaccination
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
    Description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
    Time Frame
    Baseline and 4 weeks after primary vaccination
    Title
    Percentage of Participants With an Adverse Event of Injection-site Erythema
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.
    Time Frame
    Up to 5 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Injection-site Swelling
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.
    Time Frame
    Up to 5 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Injection-site Pain
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.
    Time Frame
    Up to 5 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Pyrexia
    Description
    Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.
    Time Frame
    Up to 5 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Myalgia
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.
    Time Frame
    Up to 14 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Arthralgia
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.
    Time Frame
    Up to 14 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Headache
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.
    Time Frame
    Up to 14 days after vaccination
    Title
    Percentage of Participants With an Adverse Event of Fatigue
    Description
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.
    Time Frame
    Up to 14 days after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Japanese participant Good health or any underlying chronic illness is documented to be in stable condition Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria: Known allergy or sensitivity to any of the components of the study vaccine History of pneumococcal conjugate vaccination Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible Functional or anatomic asplenia Received immunoglobulin within 6 months before study vaccine or is planned during the study Received any investigational drugs or vaccines within 2 months before study vaccination History of pneumococcal disease (positive culture from blood or other normally sterile site) Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection History of convulsion Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency Participating in any other clinical trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    27265450
    Citation
    Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
    Results Reference
    result

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    Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

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