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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: V114

Biological: Prevnar 13™

Study type

Interventional

Funder types

Industry

Identifiers

NCT03731182

V114-023 (Other Identifier)

2018-001152-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

104 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. 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.

Exclusion criteria

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.