Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Japanese Adults (pPCV-002)
Study Details
Study Description
Brief Summary
The purpose of this phase 1, randomized, double-blind, active-comparator-controlled study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (pPCV) with that of PNEUMOVAX™ in healthy Japanese adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: pPCV Participants receive a single dose of pPCV on Day 1. |
Biological: pPCV
pPCV vaccine 1.0 mL solution, at a dose to be determined, for intramuscular (IM) injection.
Other Names:
|
| Active Comparator: PNEUMOVAX™23 Participants receive a single dose of PNEUMOVAX™23 on Day 1. |
Biological: PNEUMOVAX™23
PNEUMOVAX™23 0.5 mL solution, at a dose to be determined, for IM injection.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a Solicited Injection-site Adverse Event (AE) [Up to 5 days postvaccination]
Solicited injection-site AEs include tenderness/pain, redness/erythema, and swelling.
- Percentage of Participants With a Solicited Systemic AE [Up to 5 days postvaccination]
Solicited systemic AEs include headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue.
- Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) [Up to 30 days postvaccination]
A vaccine-related 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.
Secondary Outcome Measures
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in pPCV and Pneumovax™23 [Day 30 postvaccination]
The GMTs for serotypes common to pPCV and PNEOMOVAX™23 will be determined using the muliplex opsonophagocytic assay (MOPA).
- Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in pPCV and Pneumovax™23 [Day 30 postvaccination]
The GMCs for serotype-specific pneumococcal IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).
- Serotype-specific OPA GMTs for the Unique Serotypes in pPCV [Day 30 postvaccination]
The GMTs for serotypes unique to pPCV will be determined using the MOPA.
- Serotype-specific IgG GMCs for the Unique Serotypes in pPCV [Day 30 postvaccination]
The GMCs for serotype-specific pneumococcal IgG antibodies unique to pPCV will be determined using PnECL.
- Geometric Mean Fold Rise (GMFR) from Baseline in Serotype-specific OPA GMTs for the Common Serotypes in pPCV and Pneumovax™23 [Baseline (Day 1) and Day 30 postvaccination]
The GMFR in GMTs from baseline to Day 30 of serotypes common to pPCV and PNEOMOVAX™23 will be determined using the MOPA.
- GMFR from Baseline in Serotype-specific IgG GMCs for the Common Serotypes in pPCV and Pneumovax™23 [Baseline (Day 1) and Day 30 postvaccination]
The GMFR in GMCs from baseline to Day 30 of serotype-specific pneumococcal IgG antibodies will be determined using PnECL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
is a healthy Japanese male or female ≥20 years of age at time of randomization
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male participants must agree to be abstinent or use contraception during the study and for ≥30 days after completing the study
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female participants must not be pregnant or breastfeeding, and is either:
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not a woman of childbearing potential (WOCBP) or
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a WOCBP who agrees to remain abstinent or use contraception during the study and for ≥30 days after completing the study
Exclusion Criteria:
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has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
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has a known hypersensitivity to any vaccine components
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has impaired immunological function
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has a coagulation disorder
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had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
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has a known malignancy that is progressing/requiring treatment
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has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
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has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
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is receiving immunosuppressive therapy
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has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
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has received any live vaccine from 30 days prior to Day 1
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has received a blood transfusion or blood products
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has participated in another clinical trial within 2 months of this study
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has clinically relevant drug or alcohol abuse
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has any condition that, in the opinion of the investigator, precludes participation in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Souseikai PS Clinic ( Site 0201) | Fukuoka | Japan | 812-0025 | |
| 2 | Souseikai Nishikumamoto Hospital ( Site 0202) | Kumamoto | Japan | 861-4157 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- pPCV-002
- pPCV-002
- jRCT2071200094