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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)

21 maggio 2021 aggiornato da: Merck Sharp & Dohme LLC

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)

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

104

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Brasile
      • Salvador, Brasile, 40420-000
        • Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
      • Sao Paulo, Brasile, 01221-900
        • Santa Casa de Misericordia de Sao Paulo ( Site 0202)
    • MG
      • Belo Horizonte, MG, Brasile, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 0300)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760045
        • Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)
  • Grecia
      • Athens, Grecia, 115 27
        • Agia Sophia Children s Hospital ( Site 0700)
      • Thessaloniki, Grecia, 546 42
        • Hippokration General Hospital of Thessaloniki ( Site 0701)
  • Italia
      • Genova, Italia, 16132
        • Ospedale San Martino ( Site 0800)
  • Panama
      • Panama, Panama, 0816-00383
        • Cevaxin ( Site 0500)
      • Panama, Panama, 0816-00383
        • Cevaxin ( Site 0502)
  • Repubblica Dominicana
      • Santo Domingo, Repubblica Dominicana, 10122
        • Clinical Research Republica Dominicana ( Site 0401)
      • Santo Domingo, Repubblica Dominicana, 10205
        • Caimed Dominicana S.A.S ( Site 0400)
    • Santo Domingo
      • Distrito Nacional, Santo Domingo, Repubblica Dominicana, 10204
        • Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)
  • Stati Uniti
    • Delaware
      • Wilmington, Delaware, Stati Uniti, 19803
        • Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30303
        • Children's Healthcare of Atlanta ( Site 0100)
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Children's Hospital of Michigan ( Site 0111)
    • New Jersey
      • Newark, New Jersey, Stati Uniti, 07112
        • Newark Beth Israel Medical Center ( Site 0115)
    • New York
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester Medical Center ( Site 0105)
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Cincinnati Children's Hospital Medical Center ( Site 0101)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
Biologico: 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
Comparatore attivo: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
Biologico: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With a Solicited Injection-site Adverse Event
Lasso di tempo: Up to 14 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Up to 14 days post-vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
Lasso di tempo: Up to 14 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Up to 14 days post-vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
Lasso di tempo: Up to 6 months post-vaccination
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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Up to 6 months post-vaccination
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Lasso di tempo: Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Day 30

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Lasso di tempo: Day 30
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Lasso di tempo: Day 1 (Baseline) and Day 30
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Lasso di tempo: Day 1 (Baseline) and Day 30
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Day 1 (Baseline) and Day 30

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 gennaio 2019

Completamento primario (Effettivo)

8 giugno 2020

Completamento dello studio (Effettivo)

8 giugno 2020

Date di iscrizione allo studio

Primo inviato

2 novembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2018

Primo Inserito (Effettivo)

6 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2021

Ultimo verificato

1 maggio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • V114-023 (Altro identificatore: Merck Protocol Number)
  • 2018-001152-35 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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