A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)
NCT ID: NCT04168190
Last Updated: 2022-09-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
600 participants
INTERVENTIONAL
2019-12-06
2021-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
NCT05696080
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
NCT05420961
A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
NCT06182124
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
NCT05464420
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
NCT05569954
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1: V116 0.5 mL
Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1
V116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Phase 1: V116 1.0 mL
Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1
V116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Phase 1: Pneumovax™23
Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1
Pneumovax™23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Phase 2: V116
Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2
V116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Phase 2: Pneumovax™23
Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2
Pneumovax™23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
V116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Pneumovax™23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Platt H, Omole T, Cardona J, Fraser NJ, Mularski RA, Andrews C, Daboul N, Gallagher N, Sapre A, Li J, Polis A, Fernsler D, Tamms G, Xu W, Murphy R, Skinner J, Joyce J, Musey L. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial. Lancet Infect Dis. 2023 Feb;23(2):233-246. doi: 10.1016/S1473-3099(22)00526-6. Epub 2022 Sep 15.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
pPCV-001
Identifier Type: OTHER
Identifier Source: secondary_id
V116-001
Identifier Type: OTHER
Identifier Source: secondary_id
pPCV-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.