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Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

8. Mai 2018 aktualisiert von: GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

Studienübersicht

Detaillierte Beschreibung

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine.

All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)

Studientyp

Interventionell

Einschreibung (Tatsächlich)

363

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Mexico, Mexiko, 14000
        • GSK Investigational Site
      • Mexico city, Mexiko, 14000
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 105
        • GSK Investigational Site
      • Taoyuan Hsien, Taiwan
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Jahr bis 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Previous vaccination with a meningococcal vaccine.
  • Previous administration of a fourth dose of a pneumococcal vaccine
  • Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
  • History of meningococcal or pneumococcal invasive disease.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A
Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.
Single dose intramuscular injection.
Single dose intramuscular injection.
Aktiver Komparator: Group B
Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.
Single dose intramuscular injection.
Single dose intramuscular injection.
Aktiver Komparator: Group C
Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.
Single dose intramuscular injection.
Single dose intramuscular injection.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anti-pneumococcal Antibody Concentrations
Zeitfenster: At Month 1
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).
At Month 1
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value
Zeitfenster: At Month 1
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
At Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers
Zeitfenster: At Month 1
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
At Month 1

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anti-pneumococcal Antibody Concentrations
Zeitfenster: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE) and at one month post dose 2 (Month 2)
Cross-reactive Anti-pneumococcal Antibody Concentrations
Zeitfenster: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic Titers Against Pneumococcal Serotypes
Zeitfenster: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes
Zeitfenster: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-protein D (Anti-PD) Antibody Concentrations
Zeitfenster: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Zeitfenster: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE) and at one month post dose 2 (Month 2)
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations
Zeitfenster: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-tetanus (Anti-T) Antibody Concentrations
Zeitfenster: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Zeitfenster: Within the 4-day (Days 0-3) post-vaccination period after each dose
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: Within the 4-day (Days 0-3) post-vaccination period after each dose
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Zeitfenster: Within the 31-day (Day 0-30) post-vaccination period after each dose
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Within the 31-day (Day 0-30) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
Zeitfenster: Throughout the entire study duration (Day 0-Month 7)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Rash
Zeitfenster: Throughout the entire study duration (Day 0-Month 7)
Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
Zeitfenster: Throughout the entire study duration (Day 0-Month 7)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Zeitfenster: Throughout the entire study duration (Day 0-Month 7)
Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.
Throughout the entire study duration (Day 0-Month 7)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

30. Oktober 2008

Primärer Abschluss (Tatsächlich)

2. Juni 2009

Studienabschluss (Tatsächlich)

2. November 2009

Studienanmeldedaten

Zuerst eingereicht

23. September 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2008

Zuerst gepostet (Schätzen)

25. September 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Mai 2018

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiendaten/Dokumente

  1. Datensatzspezifikation
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinischer Studienbericht
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Kommentiertes Fallberichtsformular
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistischer Analyseplan
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einwilligungserklärung
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Einzelner Teilnehmerdatensatz
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studienprotokoll
    Informationskennung: 111393
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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