A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

Completed · Phase 1/Phase 2

Conditions studied: Pneumonia, Pneumococcal

In brief

This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 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 V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.

Key facts

Study ID

NCT04168190

Run by

Merck Sharp & Dohme LLC

People needed

600

Starts

2019-12-06

Expected to finish

2021-07-12

Last updated by the study team

2022-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Simon Williamson Clinic ( Site 0004) — Birmingham, Alabama, United States
• Central Arizona Medical Associates ( Site 0003) — Mesa, Arizona, United States
• Clinical Research of South Florida ( Site 0008) — Coral Gables, Florida, United States
• Indago Research & Health Center, Inc ( Site 0011) — Hialeah, Florida, United States
• Research Centers of America, LLC ( Site 0001) — Hollywood, Florida, United States
• QPS Miami Research Associates ( Site 0016) — Miami, Florida, United States
• L&C Professional Medical Research Institute ( Site 0009) — Miami, Florida, United States
• Advanced Medical Research Institute ( Site 0010) — Miami, Florida, United States
• Optimal Research ( Site 0006) — Peoria, Illinois, United States
• Benchmark Research ( Site 0012) — Metairie, Louisiana, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018) — Troy, Michigan, United States
• Meridian Clinical Research, LLC ( Site 0024) — Norfolk, Nebraska, United States
• Wake Research Clinical Research Center of Nevada, LLC ( Site 0014) — Las Vegas, Nevada, United States
• Meridian Clinical Research, LLC ( Site 0025) — Endwell, New York, United States
• Rochester Clinical Research, Inc. ( Site 0002) — Rochester, New York, United States
• PriMED Clinical Research ( Site 0021) — Dayton, Ohio, United States
• Advanced Medical Research ( Site 0017) — Maumee, Ohio, United States
• Kaiser Permanente Center for Health Research ( Site 0015) — Portland, Oregon, United States
• Diagnostics Research Group ( Site 0013) — San Antonio, Texas, United States
• Advanced Clinical Research ( Site 0022) — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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