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Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prevnar 13™
Pneumovax™ 23
Placebo
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

Eligibility Criteria

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

Inclusion Criteria:

  • Any chronic illness must be documented to be in stable condition
  • Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential

Exclusion Criteria:

  • Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
  • Prior administration of any pneumococcal vaccine
  • History of invasive pneumococcal disease
  • Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease
  • Received systemic corticosteroids (equivalent of >=2 mg/kg total daily dose of prednisone or >=20 mg/kg for persons weighing >10 kg) for >=14 consecutive days and has not completed treatment <=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted).
  • Has a coagulation disorder contraindicating intramuscular vaccination
  • Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease
  • Received a blood transfusion or blood products, including immunoglobulins <=6 months before receiving study vaccine, or is scheduled to receive them within 30 days
  • Participated in another clinical study of an investigational product <=2 months before or during the current study
  • Is breast-feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo

    Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23

    Arm Description

    Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.

    Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With an Adverse Event (AE)
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Percentage of Participants With an Injection-site Adverse Event
    An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.
    Percentage of Participants With a Systemic Adverse Event
    Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.
    Percentage of Participants With a Serious Adverse Event (SAE)
    A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.
    Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death
    A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.
    Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12
    Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12
    Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.

    Secondary Outcome Measures

    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.

    Full Information

    First Posted
    August 22, 2014
    Last Updated
    October 25, 2021
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02225587
    Brief Title
    Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)
    Official Title
    Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Subjects 50 Years of Age and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 28, 2014 (Actual)
    Primary Completion Date
    July 6, 2015 (Actual)
    Study Completion Date
    July 6, 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo
    Arm Type
    Experimental
    Arm Description
    Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.
    Arm Title
    Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
    Arm Type
    Placebo Comparator
    Arm Description
    Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.
    Intervention Type
    Biological
    Intervention Name(s)
    Prevnar 13™
    Intervention Description
    Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.
    Intervention Type
    Biological
    Intervention Name(s)
    Pneumovax™ 23
    Intervention Description
    Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Injections are to be administered into the deltoid muscle of the upper arm.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With an Adverse Event (AE)
    Description
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Time Frame
    Up to 14 days after any vaccination (Up to 28 weeks)
    Title
    Percentage of Participants With an Injection-site Adverse Event
    Description
    An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.
    Time Frame
    Up to 14 days after any vaccination (Up to 28 weeks)
    Title
    Percentage of Participants With a Systemic Adverse Event
    Description
    Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.
    Time Frame
    Up to 14 days after any vaccination (Up to 28 weeks)
    Title
    Percentage of Participants With a Serious Adverse Event (SAE)
    Description
    A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.
    Time Frame
    Up to 30 weeks
    Title
    Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death
    Description
    A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.
    Time Frame
    Up to 30 weeks
    Title
    Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event
    Description
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Time Frame
    Up to 26 weeks
    Title
    Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12
    Description
    Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Time Frame
    Week 12
    Title
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12
    Description
    Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8
    Description
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Time Frame
    Week 8
    Title
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26
    Description
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Time Frame
    Week 26
    Title
    Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30
    Description
    Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
    Time Frame
    Week 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any chronic illness must be documented to be in stable condition Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential Exclusion Criteria: Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial Prior administration of any pneumococcal vaccine History of invasive pneumococcal disease Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease Received systemic corticosteroids (equivalent of >=2 mg/kg total daily dose of prednisone or >=20 mg/kg for persons weighing >10 kg) for >=14 consecutive days and has not completed treatment <=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted). Has a coagulation disorder contraindicating intramuscular vaccination Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease Received a blood transfusion or blood products, including immunoglobulins <=6 months before receiving study vaccine, or is scheduled to receive them within 30 days Participated in another clinical study of an investigational product <=2 months before or during the current study Is breast-feeding
    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
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    34019468
    Citation
    Buchwald UK, Andrews CP, Ervin J, Peterson JT, Tamms GM, Krupa D, Ajiboye P, Roalfe L, Krick AL, Sterling TM, Wang M, Martin JC, Stek JE, Kohn MA, Folaranmi T, Abeygunawardana C, Hartzel J, Musey LK; V110-029 Study Group. Sequential administration of Prevnar 13 and PNEUMOVAX 23 in healthy participants 50 years of age and older. Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.
    Results Reference
    result

    Learn more about this trial

    Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)

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