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

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ClinicalTrials.gov Identifier: NCT03731182
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : August 27, 2020
Estimated Study Completion Date : August 27, 2020


Arm Intervention/treatment
Experimental: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1
Biological: 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

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




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 14 after vaccination ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, pain/tenderness, and hard lump/induration.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after vaccination ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 ]
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.

  4. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a pneumococcal electrochemiluminescence (PnECL) assay.


Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  2. Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. GMFR is GMC at Day 30 / GMC at Baseline

  3. GMFR in Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and Day 30 ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Day 30 / GMT at Baseline.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731182


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Delaware
Nemours/Alfred I. duPont Hospital for Children ( Site 0113) Recruiting
Wilmington, Delaware, United States, 19803
Contact: Study Coordinator    302-651-5500      
United States, Michigan
Children's Hospital of Michigan ( Site 0111) Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator    313-745-5382      
United States, New Jersey
Newark Beth Israel Medical Center ( Site 0115) Recruiting
Newark, New Jersey, United States, 07112
Contact: Study Coordinator    973-926-7161      
United States, New York
University of Rochester Medical Center ( Site 0105) Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    585-275-2981      
United States, Ohio
Cincinnati Children's Hospital Medical Center ( Site 0101) Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Study Coordinator    513-803-1918      
Colombia
Clinica de la Costa Ltda. ( Site 0300) Recruiting
Barranquilla, Atlantico, Colombia, 080020
Contact: Study Coordinator    +5753369940      
Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301) Recruiting
Cali, Colombia, 760045
Contact: Study Coordinator    +573156129266      
Dominican Republic
Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402) Recruiting
Distrito Nacional, Santo Domingo, Dominican Republic, 10204
Contact: Study Coordinator    +8092235435      
Clinical Research Republica Dominicana ( Site 0401) Recruiting
Santo Domingo, Dominican Republic, 10122
Contact: Study Coordinator    +8092892356      
Caimed Dominicana S.A.S ( Site 0400) Recruiting
Santo Domingo, Dominican Republic, 10205
Contact: Study Coordinator    +8099959090      
Italy
Ospedale San Martino ( Site 0800) Recruiting
Genova, Italy, 16132
Contact: Study Coordinator    +393356032236      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03731182     History of Changes
Other Study ID Numbers: V114-023
V114-023 ( Other Identifier: Merck Protocol Number )
2018-001152-35 ( EudraCT Number )
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Pneumococcal Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs