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

NCT ID: NCT03731182

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-23
• Study Completion Date: 2020-06-08

Brief Summary

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

Conditions

Pneumococcal Infections

Study Design

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

Study Groups

V114

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

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™

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Group Type: ACTIVE_COMPARATOR

Prevnar 13™

Intervention Type: BIOLOGICAL

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

Interventions

V114

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

Intervention Type: BIOLOGICAL

Prevnar 13™

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 Type: BIOLOGICAL

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

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

Countries

United States; Brazil; Colombia; Dominican Republic; Greece; Italy; Panama

References

Quinn CT, Wiedmann RT, Jarovsky D, Lopez-Medina E, Rodriguez HM, Papa M, Boggio G, Shou Q, Dagan R, Richmond P, Feemster K, McFetridge R, Tamms G, Lupinacci R, Musey L, Bickham K. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023 Feb 14;7(3):414-421. doi: 10.1182/bloodadvances.2022008037.

Reference Type: DERIVED

PMID: 36383730 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V114-023

Identifier Type: OTHER

Identifier Source: secondary_id

2018-001152-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-023

Identifier Type: -

Identifier Source: org_study_id