A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections; Anemia, Sickle Cell
Intervention: V114; Prevnar 13™
Intervention description: V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.