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The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pneumococcal Conjugate Vaccine (V114)
PNEUMOVAX® 23
PREVNAR 13®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Pneumococcal vaccines

Eligibility Criteria

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

Inclusion Criteria:

-Without fever for 72 hours prior to vaccination

Exclusion Criteria:

  • Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
  • Known or suspected to be immunocompromised
  • Functional or anatomic asplenia
  • History of autoimmune disease
  • Evidence of dementia or cognitive impairment
  • Use of any immunosuppressive therapy
  • Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
  • Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
  • Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
  • Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
  • Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    V114

    PNEUMOVAX® 23

    PREVNAR 13®

    Arm Description

    Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

    Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.

    Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With an Adverse Event
    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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
    Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
    Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.
    Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
    Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.
    Percentage of Participants With a Serious Adverse Event
    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.
    Percentage of Participants With a Vaccine-related Serious Adverse Event
    A 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 deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.
    Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.

    Secondary Outcome Measures

    Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies
    OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)

    Full Information

    First Posted
    December 27, 2011
    Last Updated
    November 26, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01513551
    Brief Title
    The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)
    Official Title
    A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 13, 2012 (Actual)
    Primary Completion Date
    February 15, 2013 (Actual)
    Study Completion Date
    February 15, 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older. The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    692 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V114
    Arm Type
    Experimental
    Arm Description
    Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
    Arm Title
    PNEUMOVAX® 23
    Arm Type
    Active Comparator
    Arm Description
    Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
    Arm Title
    PREVNAR 13®
    Arm Type
    Active Comparator
    Arm Description
    Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
    Intervention Type
    Biological
    Intervention Name(s)
    Pneumococcal Conjugate Vaccine (V114)
    Intervention Description
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
    Intervention Type
    Biological
    Intervention Name(s)
    PNEUMOVAX® 23
    Intervention Description
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
    Intervention Type
    Biological
    Intervention Name(s)
    PREVNAR 13®
    Intervention Description
    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With an Adverse Event
    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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
    Time Frame
    All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination
    Title
    Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
    Description
    Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.
    Time Frame
    Up to Day 14 postvaccination
    Title
    Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
    Description
    Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.
    Time Frame
    Up to Day 14 postvaccination
    Title
    Percentage of Participants With a Serious Adverse Event
    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.
    Time Frame
    Up to 6 months postvaccination
    Title
    Percentage of Participants With a Vaccine-related Serious Adverse Event
    Description
    A 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 deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.
    Time Frame
    Up to 6 months postvaccination
    Title
    Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.
    Time Frame
    One month postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies
    Description
    OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)
    Time Frame
    One month postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: -Without fever for 72 hours prior to vaccination Exclusion Criteria: Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine Known or suspected to be immunocompromised Functional or anatomic asplenia History of autoimmune disease Evidence of dementia or cognitive impairment Use of any immunosuppressive therapy Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
    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
    29559167
    Citation
    Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17.
    Results Reference
    derived

    Learn more about this trial

    The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

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