Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PN...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female in good health
- Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine.
- Exclusion Criteria
- History of invasive pneumococcal disease
- Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Female participant: positive urine or serum pregnancy test
- Prior administration of any pneumococcal vaccine
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
- Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted).
- Received immunosuppressive therapy
- Received a blood transfusion or blood products within 6 months of enrollment
- Participated in another clinical study of an investigational product within 2 months of enrollment
- Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Exclusion
Key Trial Info
Start Date :
June 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT03480763
Start Date
June 22 2018
End Date
December 23 2019
Last Update
November 2 2021
Active Locations (22)
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1
East Valley Family Physicians ( Site 0104)
Chandler, Arizona, United States, 85224
2
Central Phoenix Medical Clinic, LLC ( Site 0125)
Phoenix, Arizona, United States, 85020
3
Encompass Clinical Research ( Site 0118)
Spring Valley, California, United States, 91978
4
Diablo Clinical Research, Inc ( Site 0132)
Walnut Creek, California, United States, 94598