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A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V114 Medium Dose
V114 High Dose
V114 Medium Dose with Alternative Carrier Protein
V114 High Dose with Alternative Carrier Protein
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

Eligibility Criteria

2 Months - 49 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult Cohort: 18 to 49 years and in good health

  • Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.

Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion Criteria:

Adult cohort: Prior administration of any pneumococcal vaccine

  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • Coagulation disorder contraindicating intramuscular vaccination
  • Received a blood transfusion or blood products within 6 months
  • Participated in another clinical study of an investigational product within 2 months
  • Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • History of congenital or acquired immunodeficiency
  • Has or mother has documented Human Immunodeficiency virus (HIV) infection
  • Has or mother has documented hepatitis B surface antigen positive result
  • Functional or anatomic asplenia
  • History of failure to thrive
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease or autoimmune disorder
  • Known neurologic or cognitive behavioral disorder
  • Received systemic corticosteroids within 14 days
  • Received other licensed non-live vaccine within 14 days
  • Received other licensed live virus vaccine within 30 days
  • Received a blood transfusion or blood products
  • Participated in another clinical study of an investigational product
  • History of invasive pneumococcal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Adult: V114 Medium Dose

    Adult: V114 High Dose

    Adult: V114 Medium Dose with Alternative Carrier Protein

    Adult: V114 High Dose with Alternative Carrier Protein

    Infant: V114 Medium Dose

    Infant: V114 High Dose

    Infant: V114 Medium Dose with Alternative Carrier Protein

    Infant: V114 High Dose with Alternative Carrier Protein

    Infant: Prevnar 13™

    Arm Description

    Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.

    Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.

    Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.

    Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.

    Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.

    Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.

    Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.

    Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.

    Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.

    Outcomes

    Primary Outcome Measures

    Adults: Percentage of Participants With an Adverse Event
    An adverse event (AE) is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Infants: Percentage of Participants With an Adverse Event
    An AE is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
    An AE is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
    Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
    Infants: Percentage of Participants With a Solicited Systemic Adverse Event
    Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
    Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

    Secondary Outcome Measures

    Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

    Full Information

    First Posted
    August 20, 2015
    Last Updated
    March 21, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02531373
    Brief Title
    A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
    Official Title
    A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2015 (Actual)
    Primary Completion Date
    April 14, 2017 (Actual)
    Study Completion Date
    April 14, 2017 (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
    Yes

    5. Study Description

    Brief Summary
    This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

    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 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    338 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adult: V114 Medium Dose
    Arm Type
    Experimental
    Arm Description
    Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
    Arm Title
    Adult: V114 High Dose
    Arm Type
    Experimental
    Arm Description
    Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
    Arm Title
    Adult: V114 Medium Dose with Alternative Carrier Protein
    Arm Type
    Experimental
    Arm Description
    Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
    Arm Title
    Adult: V114 High Dose with Alternative Carrier Protein
    Arm Type
    Experimental
    Arm Description
    Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
    Arm Title
    Infant: V114 Medium Dose
    Arm Type
    Experimental
    Arm Description
    Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
    Arm Title
    Infant: V114 High Dose
    Arm Type
    Experimental
    Arm Description
    Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
    Arm Title
    Infant: V114 Medium Dose with Alternative Carrier Protein
    Arm Type
    Experimental
    Arm Description
    Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
    Arm Title
    Infant: V114 High Dose with Alternative Carrier Protein
    Arm Type
    Experimental
    Arm Description
    Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
    Arm Title
    Infant: Prevnar 13™
    Arm Type
    Active Comparator
    Arm Description
    Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.
    Intervention Type
    Biological
    Intervention Name(s)
    V114 Medium Dose
    Intervention Description
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
    Intervention Type
    Biological
    Intervention Name(s)
    V114 High Dose
    Intervention Description
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
    Intervention Type
    Biological
    Intervention Name(s)
    V114 Medium Dose with Alternative Carrier Protein
    Intervention Description
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
    Intervention Type
    Biological
    Intervention Name(s)
    V114 High Dose with Alternative Carrier Protein
    Intervention Description
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein 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 (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
    Primary Outcome Measure Information:
    Title
    Adults: Percentage of Participants With an Adverse Event
    Description
    An adverse event (AE) is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Time Frame
    Up to 6 weeks after vaccination
    Title
    Infants: Percentage of Participants With an Adverse Event
    Description
    An AE is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Time Frame
    Up to 1 month after Vaccination 4 (Month 11-15)
    Title
    Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
    Description
    An AE is defined as 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 AE can therefore be any unfavourable and unintended sign, 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
    Time Frame
    Up to time of Vaccination 4 (Month 10-13)
    Title
    Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
    Description
    Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
    Time Frame
    Up to 14 days after any vaccination
    Title
    Infants: Percentage of Participants With a Solicited Systemic Adverse Event
    Description
    Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
    Time Frame
    Up to 14 days after any vaccination
    Title
    Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    1 month after Vaccination 3 (Month 5)
    Secondary Outcome Measure Information:
    Title
    Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    1 month after vaccination
    Title
    Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
    Time Frame
    Baseline and 1 month after vaccination
    Title
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    1 month after Vaccination 3 (Month 5)
    Title
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    Before Vaccination 4 (Month 10-13)
    Title
    Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    1 month after Vaccination 4 (Month 11-15)
    Title
    Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    Before Vaccination 4 (Month 10-13)
    Title
    Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
    Description
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
    Time Frame
    1 month after Vaccination 4 (Month 11-15)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult Cohort: 18 to 49 years and in good health Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine. Infant Cohort: approximately 2 months (42 to 90 days) and in good health. Exclusion Criteria: Adult cohort: Prior administration of any pneumococcal vaccine History of invasive pneumococcal disease Known hypersensitivity to any vaccine component Known or suspected impairment of immune function Coagulation disorder contraindicating intramuscular vaccination Received a blood transfusion or blood products within 6 months Participated in another clinical study of an investigational product within 2 months Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine Known hypersensitivity to any vaccine component Known or suspected impairment of immune function History of congenital or acquired immunodeficiency Has or mother has documented Human Immunodeficiency virus (HIV) infection Has or mother has documented hepatitis B surface antigen positive result Functional or anatomic asplenia History of failure to thrive Coagulation disorder contraindicating intramuscular vaccination History of autoimmune disease or autoimmune disorder Known neurologic or cognitive behavioral disorder Received systemic corticosteroids within 14 days Received other licensed non-live vaccine within 14 days Received other licensed live virus vaccine within 30 days Received a blood transfusion or blood products Participated in another clinical study of an investigational product History of invasive pneumococcal disease
    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
    30689507
    Citation
    Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.
    Results Reference
    result

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    A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

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