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A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
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 Disease

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For participants 50 years of age or older: any underlying chronic illness must be in stable condition
  • For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
  • Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

Exclusion Criteria:

  • Received prior vaccination with pneumococcal vaccine
  • Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
  • Has history of autoimmune disease
  • Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
  • Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
  • Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)
  • Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
  • Hospitalized for acute illness within 3 months before study vaccination
  • Is a pregnant woman or nursing mother
  • History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
  • History of fever illness within 3 days before study vaccination
  • Received antibiotic therapy for any acute illness within 7 days before study vaccination
  • Hypersensitivity to any components of the vaccine, including phenol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Pneumovax™ 23: Participants Between 2 and 49 Years

    Pneumovax™ 23: Participants >=50 Years

    Arm Description

    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

    Outcomes

    Primary Outcome Measures

    Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
    Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
    Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
    Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.
    Number of Participants Reporting Serious Adverse Experiences
    A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2012
    Last Updated
    October 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01734239
    Brief Title
    A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)
    Official Title
    A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 3, 2013 (Actual)
    Primary Completion Date
    October 22, 2013 (Actual)
    Study Completion Date
    October 22, 2013 (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 Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pneumovax™ 23: Participants Between 2 and 49 Years
    Arm Type
    Experimental
    Arm Description
    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
    Arm Title
    Pneumovax™ 23: Participants >=50 Years
    Arm Type
    Experimental
    Arm Description
    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Pneumovax™ 23
    Other Intervention Name(s)
    V110
    Intervention Description
    Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
    Primary Outcome Measure Information:
    Title
    Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
    Description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
    Time Frame
    Prevaccination and Day 28 after vaccination
    Title
    Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
    Description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
    Time Frame
    Day 28 postvaccination
    Title
    Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
    Time Frame
    Up to 5 days postvaccination
    Title
    Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.
    Time Frame
    Up to Day 14 postvaccination
    Title
    Number of Participants Reporting Serious Adverse Experiences
    Description
    A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention
    Time Frame
    Up to Day 28 postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For participants 50 years of age or older: any underlying chronic illness must be in stable condition For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination Exclusion Criteria: Received prior vaccination with pneumococcal vaccine Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids Has history of autoimmune disease Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine) Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination Hospitalized for acute illness within 3 months before study vaccination Is a pregnant woman or nursing mother History of invasive pneumococcal disease or of other culture-positive pneumococcal disease History of fever illness within 3 days before study vaccination Received antibiotic therapy for any acute illness within 7 days before study vaccination Hypersensitivity to any components of the vaccine, including phenol
    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
    27149114
    Citation
    Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=V110-018&kw=V110-018&tab=access

    Learn more about this trial

    A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

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