A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)

NCT ID: NCT03615482

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2019-06-24

Brief Summary

This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.

Conditions

Pneumococcal Infections

Study Design

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

Study Groups

Concomitant Vaccination

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

QIV

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

Matching Placebo for V114

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

Non-concomitant Vaccination

Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

QIV

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

Matching Placebo for V114

Intervention Type: BIOLOGICAL

Single 0.5 mL injection

Interventions

V114

Single 0.5 mL injection

Intervention Type: BIOLOGICAL

QIV

Single 0.5 mL injection

Intervention Type: BIOLOGICAL

Matching Placebo for V114

Single 0.5 mL injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Quadrivalent influenza vaccine (seasonal inactivated); Fluarix Quadrivalent (Influenza Vaccine)

Eligibility Criteria

Inclusion Criteria

• In good health. Any underlying chronic illness must be documented to be in stable condition.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive methods as defined in the protocol 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 before Visit 1 (Day 1)
• Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
• Known hypersensitivity to any component of influenza vaccines, including egg protein, or following a previous dose of any influenza vaccine.
• Known or suspected impairment of immunological function
• Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza vaccination
• Coagulation disorder contraindicating intramuscular vaccinations.
• 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)
• Prior administration of any PCV (e.g., Prevnar 13®) or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
• Prior administration of PNEUMOVAX®23 ≤12 months before Visit 1 (Note: individuals who received PNEUMOVAX®23 >12 months prior to Visit 1 are eligible for this study.)
• Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to receive any influenza vaccine during the study outside of the protocol
• Received systemic corticosteroids (≥20 mg/day prednisone equivalent) 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).
• 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 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.
• Is 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.
• Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator.
• 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

Achieve Clinical Research, LLC ( Site 0046)

Birmingham, Alabama, United States

Synexus Clinical Research US, Inc. ( Site 0039)

Chandler, Arizona, United States

Synexus Clinical Research, US,Inc/Central Arizona Medical Associates, PC ( Site 0004)

Mesa, Arizona, United States

Synexus Clinical Research US, Inc. ( Site 0042)

Scottsdale, Arizona, United States

Southland Clinical Research Center ( Site 0033)

Fountain Valley, California, United States

Valley Clinical Trials Inc. ( Site 0001)

Northridge, California, United States

Center for Clinical Trials, LLC ( Site 0025)

Paramount, California, United States

Artemis Institute for Clinical Research ( Site 0026)

San Diego, California, United States

California Research Foundation ( Site 0002)

San Diego, California, United States

Bayview Research Group, LLC ( Site 0010)

Valley Village, California, United States

Synexus Clinical Research US, Inc./Colorado Springs Family Practice ( Site 0021)

Colorado Springs, Colorado, United States

Indago Research & Health Center, Inc ( Site 0007)

Hialeah, Florida, United States

Research Centers of America, LLC ( Site 0036)

Hollywood, Florida, United States

Suncoast Research Group, LLC ( Site 0020)

Miami, Florida, United States

L&C Professional Medical Research Institute ( Site 0015)

Miami, Florida, United States

Alpha Science Research ( Site 0018)

Miami, Florida, United States

Lakes Research LLC ( Site 0034)

Miami Lakes, Florida, United States

Evanston Premier Healthcare & Research, LLC. ( Site 0012)

Evanston, Illinois, United States

Healthcare Research Network LLC ( Site 0006)

Flossmoor, Illinois, United States

Springfield Clinic ( Site 0045)

Springfield, Illinois, United States

Heartland Research Associates, LLC ( Site 0031)

Augusta, Kansas, United States

Heartland Research Associates, LLC ( Site 0016)

Newton, Kansas, United States

Kentucky Pediatric/Adult Research Inc ( Site 0011)

Bardstown, Kentucky, United States

Community Clinical Research Network (Marlboro, MA) ( Site 0030)

Marlborough, Massachusetts, United States

Healthcare Research Network LLC ( Site 0032)

Hazelwood, Missouri, United States

Clinical Research Center of Neveda, LLC. ( Site 0022)

Las Vegas, Nevada, United States

Southwest CARE Center ( Site 0013)

Santa Fe, New Mexico, United States

Regional Clinical Research, Inc. ( Site 0029)

Endwell, New York, United States

Mid Hudson Medical Research ( Site 0024)

New Windsor, New York, United States

Rochester Clinical Research, Inc. ( Site 0009)

Rochester, New York, United States

PMG Research Of Cary LLC ( Site 0035)

Cary, North Carolina, United States

Unity Clinical Research ( Site 0044)

Lindsay, Oklahoma, United States

Clinical Research Center Of Reading LLP ( Site 0014)

Wyomissing, Pennsylvania, United States

Omega Medical Research ( Site 0049)

Warwick, Rhode Island, United States

PMG Research Inc ( Site 0027)

Mt. Pleasant, South Carolina, United States

Holston Medical Group ( Site 0003)

Bristol, Tennessee, United States

Holston Medical Group ( Site 0028)

Kingsport, Tennessee, United States

Clinical Research Associates Inc. ( Site 0040)

Nashville, Tennessee, United States

Wellness Clinical Research Associates ( Site 0048)

Allen, Texas, United States

Benchmark Research ( Site 0037)

Fort Worth, Texas, United States

San Gabriel Clinical Research ( Site 0047)

Georgetown, Texas, United States

Synexus Clinical Research US, Inc. ( Site 0019)

San Antonio, Texas, United States

Charlottesville Medical Research Center, LLC ( Site 0008)

Charlottesville, Virginia, United States

Clinical Research Partners, LLC. ( Site 0005)

Richmond, Virginia, United States

Allegiance Research Specialists ( Site 0017)

Wauwatosa, Wisconsin, United States

Countries

United States

References

Severance R, Schwartz H, Dagan R, Connor L, Li J, Pedley A, Hartzel J, Sterling TM, Nolan KM, Tamms GM, Musey LK, Buchwald UK. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged >/=50 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 10.1080/21645515.2021.1976581. Epub 2021 Nov 2.

Reference Type: BACKGROUND

PMID: 34726574 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V114-021

Identifier Type: OTHER

Identifier Source: secondary_id

V114-021

Identifier Type: -

Identifier Source: org_study_id