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

NCT ID: NCT03950856

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2020-04-03

Brief Summary

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.

Conditions

Pneumococcal Infections; Pneumonia, Pneumococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V114 Lot 1

Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Group Type: EXPERIMENTAL

V114

Intervention Type: DRUG

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

V114 Lot 2

Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Group Type: EXPERIMENTAL

V114

Intervention Type: DRUG

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

V114 Lot 3

Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Group Type: EXPERIMENTAL

V114

Intervention Type: DRUG

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

Prevnar 13™

Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

Group Type: ACTIVE_COMPARATOR

Prevnar 13™

Intervention Type: DRUG

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.

Interventions

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

Intervention Type: DRUG

Prevnar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Synexus Clinical Research US, Inc. ( Site 1031)

Chandler, Arizona, United States

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

Wellness Clinical Research Associates ( Site 1038)

Allen, Texas, United States

Diagnostics Research Group ( Site 1042)

San Antonio, Texas, United States

Synexus ( Site 1000)

Murray, Utah, United States

Advanced Clinical Research ( Site 1028)

West Jordan, Utah, United States

Allegiance Research Specialists ( Site 1013)

Wauwatosa, Wisconsin, United States

Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 6006)

Blacktown, New South Wales, Australia

Australian Clinical Research Network ( Site 6000)

Maroubra, New South Wales, Australia

Box Hill Hospital ( Site 6001)

Box Hill, Victoria, Australia

Trialswest ( Site 6004)

Murdoch, Western Australia, Australia

CESFAM Colina ( Site 2002)

Santiago, RM, Chile

Clinica Alemana de Santiago Adolescencia ( Site 2000)

Santiago, Santiago Metropolitan, Chile

Instituto Nacional del Torax ( Site 2004)

Santiago, , Chile

Centro de Investigacion Clinica UC CICUC ( Site 2001)

Santiago, , Chile

Hospital Dr. Hernan Henriquez Aravena ( Site 2003)

Temuco, , Chile

Aalborg University Hospital ( Site 3003)

Aalborg, , Denmark

Aarhus Universitets hospital ( Site 3004)

Aarhus N, , Denmark

CCBR. Center for Clinical and Basic Research ( Site 3000)

Ballerup Municipality, , Denmark

Rigshospitalet ( Site 3005)

Copenhagen, , Denmark

Hvidovre Hospital ( Site 3002)

Hvidovre, , Denmark

Odense Universitetshospital ( Site 3001)

Odense, , Denmark

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 4006)

Helsinki, , Finland

Jarvenpaan rokotetutkimuskeskus ( Site 4005)

Järvenpää, , Finland

Kokkolan rokotetutkimusklinikka ( Site 4002)

Kokkola, , Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 4001)

Oulu, , Finland

Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 4004)

Pori, , Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 4000)

Tampere, , Finland

Turun rokotetutkimuskeskus ( Site 4003)

Turku, , Finland

Medinova Lakeside Dedicated Research Centre ( Site 5004)

Corby, Northamptonshire, United Kingdom

GP Direct ( Site 5000)

Harrow, , United Kingdom

Vauxhall Primary Health Care ( Site 5002)

Liverpool, , United Kingdom

Countries

United States; Australia; Chile; Denmark; Finland; United Kingdom

References

Simon JK, Staerke NB, Hemming-Harlo M, Layle S, Dagan R, Shekar T, Pedley A, Jumes P, Tamms G, Sterling T, Musey L, Buchwald UK; V114-020 PNEU-TRUE study group. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged >/=50 years: A randomized phase 3 trial (PNEU-TRUE). Vaccine. 2022 Feb 23;40(9):1342-1351. doi: 10.1016/j.vaccine.2021.12.067. Epub 2022 Jan 14.

Reference Type: DERIVED

PMID: 35039194 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V114-020

Identifier Type: OTHER

Identifier Source: secondary_id

2018-004266-33

Identifier Type: OTHER

Identifier Source: secondary_id

V114-020

Identifier Type: -

Identifier Source: org_study_id