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Trial record 1 of 11 for:    Pneumovax 23 merck | Pneumonia
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A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168190
Recruitment Status : Completed
First Posted : November 19, 2019
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of pPCV when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: pPCV is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in pPCV at 30 days postvaccination are statistically significantly greater following vaccination with pPCV than those following vaccination with Pneumovax™23.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Drug: pPCV Biological: Pneumovax™23 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.
Actual Study Start Date : December 6, 2019
Actual Primary Completion Date : July 12, 2021
Actual Study Completion Date : July 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Phase 1: pPCV-1
Single intramuscular (IM) 0.5 mL vaccination on Day 1
Drug: pPCV
Single 0.5 or 1.0 mL IM injection

Experimental: Phase 1: pPCV-2
Single IM 1.0 mL vaccination on Day 1
Drug: pPCV
Single 0.5 or 1.0 mL IM injection

Active Comparator: Phase 1: Pneumovax™23
Single IM 0.5 mL vaccination on Day 1
Biological: Pneumovax™23
Single 0.5 mL IM injection

Experimental: Phase 2: pPCV
Single IM vaccination on Day 1 at dose to be determined.
Drug: pPCV
Single 0.5 or 1.0 mL IM injection

Active Comparator: Phase 2: Pneumovax™23
Single IM 0.5 mL vaccination on Day 1
Biological: Pneumovax™23
Single 0.5 mL IM injection




Primary Outcome Measures :
  1. Percentage of Participants With a Solicited Injection-site Adverse Event (AE): Phase 1 [ Time Frame: up to 5 days post-vaccination ]
    Injection-site AEs solicited on the Vaccine Report Card (VRC) are redness/erythema, swelling, and tenderness/pain. The percentage of participants with 1 or more solicited injection-site AE will be assessed.

  2. Percentage of Participants With a Solicited Systemic AE: Phase 1 [ Time Frame: Up to 5 days post-vaccination ]
    Systemic AEs solicited on the VRC are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE will be assessed.

  3. Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs): Phase 1 [ Time Frame: Up to Day 180 ]
    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. The percentage of participants with 1 or more SAE will be assessed

  4. Percentage of Participants With a Solicited injection-site AE: Phase 2 [ Time Frame: up to 5 days post-vaccination ]
    Injection-site AEs solicited on the Vaccine Report Card (VRC) are redness/erythema, swelling, and tenderness/pain. The percentage of participants with 1 or more solicited injection-site AE will be assessed.

  5. Percentage of Participants With a Solicited Systemic AE: Phase 2 [ Time Frame: Up to 5 days post-vaccination ]
    Systemic AEs solicited on the VRC are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE will be assessed.

  6. Percentage of Participants With Vaccine-related SAEs: Phase 2 [ Time Frame: Up to Day 180 ]
    An 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. The percentage of participants who experience at least 1 SAE that was reported as at least possibly related to the study vaccine will be assessed.

  7. Serotype-specific Opsonophagocytic Activity (OPA) GMTs for the Common Serotypes in pPCV and Pneumovax™23: Phase 2 [ Time Frame: 30 days post vaccination ]
    GMTs for the serotypes common to pPCV and Pneumovax™23 will be determined using the muliplex opsonophagocytic assay (MOPA).

  8. Serotype-specific OPA GMTs for the Unique Serotypes in pPCV: Phase 2 [ Time Frame: 30 days post vaccination ]
    GMTs for the serotypes unique to pPCV will be determined using the MOPA.


Secondary Outcome Measures :
  1. Percentage of Participants Who Experience at Least 1 AE: Phase 1 [ Time Frame: Up to 5 days post-vaccination ]
    An AE is defined as 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. The percentage of participants with at least 1 AE will be assessed.

  2. Percentage of Participants Who Experience at Least 1 Vaccine-related AE: Phase 1 [ Time Frame: Up to 5 days post-vaccination ]
    An AE is defined as 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. The percentage of participants with at least 1 AE reported as at least possibly related to study vaccine will be assessed.

  3. Percentage of Participants Who Experience at Least 1 SAE: Phase 1 [ Time Frame: Up to Day 180 ]
    An 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. The percentage of participants who experience at least 1 SAE will be assessed.

  4. Percentage of Participants Who Died: Phase 1 [ Time Frame: Up to Day 180 ]
    The percentage of participants who died from any cause during the study will be assessed.

  5. Percentage of Participants Maximum Body Temperature ≥100.4°F (≥38.0°C): Phase 1 [ Time Frame: Up to 5 days post-vaccination ]
    Oral body temperatures will be documented by participants using the VRC. The percentage of participants that report a maximum body of ≥100.4°F (≥38.0°C) will be assessed.

  6. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in pPCV and Pneumovax™23: Phase 1 [ Time Frame: 30 days post vaccination ]
    GMTs for the serotypes common to pPCV and Pneumovax™23 will be determined using the MOPA.

  7. Serotype-specific Immunoglobin G (IgG) Geometric mean Concentrations (GMCs) for the Common Serotypes in pPCV and Pneumovax™23: Phase 1 [ Time Frame: 30 days post vaccination ]
    Serotype-specific pneumococcal IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).

  8. Serotype-specific Immunoglobin G (IgG) Geometric mean Concentrations (GMCs) for the Serotypes Unique to pPCV: Phase 1 [ Time Frame: 30 days post vaccination ]
    Serotype-specific pneumococcal IgG antibodies will be determined using PnECL.

  9. Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA: Phase 1 [ Time Frame: Baseline (Day 1) and 30 days postvaccination ]
    GMTs for the serotypes in pPCV and Pneumovax™23 will be determined using the MOPA at baseline and 30 days post vaccination. The GMFR (Day 30 GMT]/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype will be calculated.

  10. Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG: Phase 1 [ Time Frame: Baseline (Day 1) and 30 days post vaccination ]
    GMCs for the serotypes in pPCV and Pneumovax™23 will be determined by PnECL at baseline and 30 days post vaccination. The GMFR (Day 30 GMT]/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype will be calculated.

  11. Percentage of Participants Who Experience at Least 1 AE: Phase 2 [ Time Frame: Up to 5 days post-vaccination ]
    An AE is defined as 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. The percentage of participants who experience at least 1 AE will be assessed.

  12. Percentage of Participants Who Experience at Least 1 Vaccine-related AE: Phase 2 [ Time Frame: Up to 5 days post-vaccination ]
    An AE is defined as 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. The percentage of participants with at least 1 AE reported as at least possibly related to study vaccine will be assessed.

  13. Percentage of Participants Who Experience at Least 1 SAE: Phase 2 [ Time Frame: Up to Day 180 ]
    An 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. The percentage of participants that experience at least 1 SAE will be assessed.

  14. Percentage of Participants Who Died: Phase 2 [ Time Frame: Up to Day 180 ]
    The percentage of participants who died from any cause during the study will be assessed.

  15. Percentage of Participants Maximum Body Temperature ≥100.4°F (≥38.0°C): Phase 2 [ Time Frame: Up to 5 days post-vaccination ]
    Oral body temperatures will be documented by participants using the VRC. The percentage of participants that report a maximum body of ≥100.4°F (≥38.0°C) will be assessed.

  16. Serotype-specific IgG GMCs for the Common Serotypes in pPCV and Pneumovax™23: Phase 2 [ Time Frame: 30 days post vaccination ]
    Serotype-specific pneumococcal IgG antibodies will be determined using PnECL.

  17. Serotype-specific IgG GMCs for the serotypes unique to pPCV: Phase 2 [ Time Frame: 30 days post vaccination ]
    Serotype-specific pneumococcal IgG antibodies will assayed using PnECL.

  18. Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA: Phase 2 [ Time Frame: Baseline (Day 1) and 30 days post vaccination ]
    GMTs for the serotypes in pPCV and Pneumovax™23 will be determined using the MOPA at baseline and at 30 days post vaccination. The GMFR for each pneumococcal IgG serotype will be calculated as Day 30 GMT]/Day 1 GMT.

  19. GMFR From Baseline in GMCs of Serotype-specific IgG: Phase 2 [ Time Frame: Baseline (Day 1) and 30 days post vaccination ]
    GMCs for each serotype common in pPCV and Pneumovax™23 will be determined using PnECL at baseline and 30 days post vaccination. The GMFR for each pneumococcal IgG serotype will be calculated as Day 30 GMC]/Day 1 GMC.

  20. Percentage of Participants Who Achieve a ≥4-fold increase in Serotype-specific OPA Responses from Prevaccination (Baseline; {[Day 1)] to 30 days Post Vaccination: Phase 2 [ Time Frame: Baseline (Day 1) and 30 days post vaccination ]
    The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype will be calculated. Titer levels will be determined by the MOPA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Phase 1:
  • Male or female, from 18 years to 49 years of age inclusive
  • Phase 2:
  • Male or female ≥50 years of age Phase 1 and Phase 2
  • Males: refrain from donating sperm, remain abstinent during study or agree to use condom
  • Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent

Exclusion Criteria

  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening
  • Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
  • Coagulation disorder contraindicating IM vaccination
  • Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening
  • Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [eg, breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
  • Pregnant
  • Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol.
  • Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
  • Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168190


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04168190    
Other Study ID Numbers: pPCV-001
pPCV-001 ( Other Identifier: Merck Protocol Number )
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Pneumonia
Pneumonia, Bacterial
Heptavalent Pneumococcal Conjugate Vaccine
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Immunologic Factors
Physiological Effects of Drugs