A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

Completed · Phase 3

Conditions studied: Pneumococcal Infections

In brief

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

Key facts

Study ID

NCT03731182

Run by

Merck Sharp & Dohme LLC

People needed

104

Starts

2019-01-23

Expected to finish

2020-06-08

Last updated by the study team

2021-06-16

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of sickle cell disease in their medical record
• Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
• not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
• Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.

You may not qualify if…

• History of Invasive Pneumococcal Disease (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 conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
• Known or suspected impairment of immunological function
• History of congenital or acquired immunodeficiency
• Documented human immunodeficiency virus (HIV) infection
• History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
• Known coagulation disorder contraindicating intramuscular vaccination
• History of malignancy ≤5 years prior to signing informed consent/assent, 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)
• Received any PCV or pneumococcal polysaccharide vaccine <3 years before Visit 1 (Day 1)
• Five (5) years of age and has received <3 doses of PCV
• 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. Note: hydroxyurea is permitted
• Received immunoglobulin within 6 months before receipt of study vaccine
• Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
• Recent history (within the last year) of more than 3 inpatient hospitalizations
• At the time of signing informed consent/assent, 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
• History or current evidence of any condition, therapy, lab 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 in the opinion of the Investigator
• Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Where it is running

• Nemours/Alfred I. duPont Hospital for Children ( Site 0113) — Wilmington, Delaware, United States
• Children's Healthcare of Atlanta ( Site 0100) — Atlanta, Georgia, United States
• Children's Hospital of Michigan ( Site 0111) — Detroit, Michigan, United States
• Newark Beth Israel Medical Center ( Site 0115) — Newark, New Jersey, United States
• University of Rochester Medical Center ( Site 0105) — Rochester, New York, United States
• Cincinnati Children's Hospital Medical Center ( Site 0101) — Cincinnati, Ohio, United States
• Santa Casa de Misericordia de Belo Horizonte ( Site 0200) — Belo Horizonte, Minas Gerais, Brazil
• Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205) — Salvador, Brazil
• Santa Casa de Misericordia de Sao Paulo ( Site 0202) — São Paulo, Brazil
• Clinica de la Costa Ltda. ( Site 0300) — Barranquilla, Atlántico, Colombia
• Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301) — Cali, Valle del Cauca Department, Colombia
• Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402) — Distrito Nacional, Santo Domingo Province, Dominican Republic
• Clinical Research Republica Dominicana ( Site 0401) — Santo Domingo, Dominican Republic
• Caimed Dominicana S.A.S ( Site 0400) — Santo Domingo, Dominican Republic
• Agia Sophia Children s Hospital ( Site 0700) — Athens, Greece
• Hippokration General Hospital of Thessaloniki ( Site 0701) — Thessaloniki, Greece
• Ospedale San Martino ( Site 0800) — Genova, Italy
• Cevaxin ( Site 0500) — Panama City, Panama
• Cevaxin ( Site 0502) — Panama City, Panama

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.