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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumococcal Infections

In brief

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.

Key facts

Study ID: NCT03615482
Run by: Merck Sharp & Dohme LLC
People needed: 1200
Starts: 2018-09-14
Expected to finish: 2019-06-24
Last updated by the study team: 2024-05-22

Who can join

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

You may qualify if…

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.

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 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.

Where it is running

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

Full record on ClinicalTrials.gov

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