Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

Completed · Phase 3

Conditions studied: Pneumococcal Infections, Pneumonia, Pneumococcal

In brief

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.

Key facts

Study ID

NCT03950856

Run by

Merck Sharp & Dohme LLC

People needed

2340

Starts

2019-06-12

Expected to finish

2020-04-03

Last updated by the study team

2021-04-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.

You may not qualify if…

• History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).
• Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), 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 intramuscular vaccinations.
• 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 before receipt of study vaccine.
• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).
• Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
• Has 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.
• Has 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).
• Is 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.
• Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)
• Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met.
• Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
• Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
• In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.
• History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Where it is running

• Synexus ( Site 1043) — Mesa, Arizona, United States
• Southland Clinical Research Center ( Site 1027) — Fountain Valley, California, United States
• Valley Clinical Trials Inc. ( Site 1003) — Northridge, California, United States
• Center for Clinical Trials, LLC ( Site 1019) — Paramount, California, United States
• California Research Foundation ( Site 1006) — San Diego, California, United States
• Artemis Institute for Clinical Research ( Site 1041) — San Marcos, California, United States
• Alta California Medical Group ( Site 1020) — Simi Valley, California, United States
• Alliance for Multispecialty Research, LLC ( Site 1029) — Coral Gables, Florida, United States
• Accel Research Sites-DeLand Clinical Research Unit ( Site 1026) — DeLand, Florida, United States
• Jacksonville Center for Clinical Research ( Site 1014) — Jacksonville, Florida, United States
• L&C Professional Medical Research Institute ( Site 1012) — Miami, Florida, United States
• Alpha Science Research ( Site 1015) — Miami, Florida, United States
• QPS Miami Research Associates ( Site 1035) — South Miami, Florida, United States
• Benchmark Research ( Site 1040) — Metairie, Louisiana, United States
• Centennial Medical Group ( Site 1010) — Elkridge, Maryland, United States
• Community Clinical Research Network (Marlboro, MA) ( Site 1025) — Marlborough, Massachusetts, United States
• Wake Research Clinical Research Center of Nevada, LLC ( Site 1044) — Las Vegas, Nevada, United States
• Southwest CARE Center ( Site 1011) — Santa Fe, New Mexico, United States
• Corning Center For Clinical Research ( Site 1033) — Corning, New York, United States
• Regional Clinical Research, Inc. ( Site 1024) — Endwell, New York, United States
• Rochester Clinical Research, Inc. ( Site 1039) — Rochester, New York, United States
• PMG Research of Winston Salem ( Site 1037) — Winston-Salem, North Carolina, United States
• Unity Clinical Research ( Site 1036) — Lindsay, Oklahoma, United States
• Coastal Carolina Research Center ( Site 1034) — Mt. Pleasant, South Carolina, United States
• Synexus Clinical Research US, Inc. ( Site 1031) — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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