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)
Completed · Phase 3
Conditions studied: Pneumococcal Infections
In brief
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 PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
Key facts
- Study ID
- NCT03480763
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 652
- Starts
- 2018-06-22
- Expected to finish
- 2019-12-23
- Last updated by the study team
- 2021-11-02
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- East Valley Family Physicians ( Site 0104) — Chandler, Arizona, United States
- Central Phoenix Medical Clinic, LLC ( Site 0125) — Phoenix, Arizona, United States
- Encompass Clinical Research ( Site 0118) — Spring Valley, California, United States
- Diablo Clinical Research, Inc ( Site 0132) — Walnut Creek, California, United States
- Clinical Research of South Florida ( Site 0126) — Coral Gables, Florida, United States
- QPS Miami Research Associates ( Site 0116) — South Miami, Florida, United States
- Heartland Research Associates, Llc ( Site 0115) — Wichita, Kansas, United States
- Centennial Medical Group ( Site 0109) — Elkridge, Maryland, United States
- Rapid Medical Research, Inc. ( Site 0119) — Cleveland, Ohio, United States
- University of Texas Medical Branch at Galveston ( Site 0127) — Galveston, Texas, United States
- Texas Center For Drug Development ( Site 0107) — Houston, Texas, United States
- Diagnostics Research Group ( Site 0100) — San Antonio, Texas, United States
- J Lewis Research Inc / Foothill Family Clinic ( Site 0123) — Salt Lake City, Utah, United States
- J Lewis Research Inc/Jordan River Family Medicine ( Site 0114) — South Jordan, Utah, United States
- Health Research of Hampton Roads, Inc. ( Site 0106) — Newport News, Virginia, United States
- Seoul National University Hospital ( Site 0400) — Seoul, South Korea
- Korea University Guro Hospital ( Site 0401) — Seoul, South Korea
- CAP Centelles ( Site 0303) — Centelles, Barcelona, Spain
- Instituto de Ciencias Medicas.ICM ( Site 0301) — Alicante, Spain
- Fundacion Oftalmologica del Mediterraneo ( Site 0300) — Valencia, Spain
- National Cheng Kung University Hospital ( Site 0502) — Dawan, Taiwan
- National Taiwan University Hospital ( Site 0500) — Taipei, Taiwan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.