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Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

15. November 2019 aktualisiert von: GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.

Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1000

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

  • Finnland
      • Espoo, Finnland, 02100
        • GSK Investigational Site
      • Helsinki, Finnland, 00100
        • GSK Investigational Site
      • Helsinki, Finnland, 00930
        • GSK Investigational Site
      • Jarvenpaa, Finnland, 04400
        • GSK Investigational Site
      • Kotka, Finnland, 48600
        • GSK Investigational Site
      • Kuopio, Finnland, 70100
        • GSK Investigational Site
      • Lahti, Finnland, 15140
        • GSK Investigational Site
      • Oulu, Finnland, 90100
        • GSK Investigational Site
      • Pori, Finnland, 28100
        • GSK Investigational Site
      • Seinajoki, Finnland, 60100
        • GSK Investigational Site
      • Tampere, Finnland, 33100
        • GSK Investigational Site
      • Turku, Finnland, 20520
        • GSK Investigational Site
      • Vantaa, Finnland, 01300
        • GSK Investigational Site
      • Vantaa, Finnland, 01600
        • 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 vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
  • Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
  • History of meningococcal disease.
  • Previous vaccination against measles, mumps, rubella, and/or varicella.
  • History of measles, mumps, rubella and/or varicella.
  • Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
  • 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: Nimenrix + Priorix-Tetra Group
Subjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.
Biologisch: Meningococcal vaccine GSK134612 (Nimenrix)
Single dose intramuscular injection
Biologisch: Priorix-Tetra
2-dose subcutaneous injection
Experimental: Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
Biologisch: Meningococcal vaccine GSK134612 (Nimenrix)
Single dose intramuscular injection
Biologisch: Priorix-Tetra
2-dose subcutaneous injection
Aktiver Komparator: Priorix-Tetra Group
Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.
Biologisch: Priorix-Tetra
2-dose subcutaneous injection
Biologisch: Meningitec
Single dose intramuscular injection
Aktiver Komparator: Meningitec Group
Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
Biologisch: Priorix-Tetra
2-dose subcutaneous injection
Biologisch: Meningitec
Single dose intramuscular injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
Zeitfenster: 42 days after the first vaccine dose (Day 42)
The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
Zeitfenster: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
Zeitfenster: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
Zeitfenster: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
Zeitfenster: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.
42 days after the first vaccine dose (Day 42)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
Zeitfenster: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Zeitfenster: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
Zeitfenster: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
Zeitfenster: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Zeitfenster: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Zeitfenster: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Zeitfenster: 42 days after the first vaccine dose (Day 42)
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.
42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Zeitfenster: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-mumps Antibody Concentrations
Zeitfenster: 42 days after the first vaccine dose (Day 42)
Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.
42 days after the first vaccine dose (Day 42)
Anti-mumps Antibody Concentrations
Zeitfenster: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-rubella Antibody Concentrations
Zeitfenster: 42 days after the first vaccine dose (Day 42)
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.
42 days after the first vaccine dose (Day 42)
Anti-rubella Antibody Concentrations
Zeitfenster: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-varicella Antibody Titers
Zeitfenster: 42 days after the first vaccine dose (Day 42)
Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.
42 days after the first vaccine dose (Day 42)
Anti-varicella Antibody Titers
Zeitfenster: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
42 days after the second Priorix-Tetra vaccine dose (Day 126)
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination
Zeitfenster: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0
Zeitfenster: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.
During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Number of Subjects Reporting Solicited General Symptoms
Zeitfenster: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.
During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms
Zeitfenster: During the 43-day (Days 0-42) after first vaccination dose
Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.
During the 43-day (Days 0-42) after first vaccination dose
Number of Subjects Reporting Specific Adverse Events (AEs)
Zeitfenster: From Day 0 up to Month 6 after first vaccine dose
Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.
From Day 0 up to Month 6 after first vaccine dose
Number of Subjects Reporting Unsolicited Symptoms
Zeitfenster: During the 43-day (Days 0-42) post Dose 1 vaccination period
Unsolicited symptom covers any symptom 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.
During the 43-day (Days 0-42) post Dose 1 vaccination period
Number of Subjects Reporting Unsolicited Symptoms
Zeitfenster: During the 43-day (Days 0-42) follow-up period after each vaccination
Unsolicited symptom covers any symptom 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.
During the 43-day (Days 0-42) follow-up period after each vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Zeitfenster: From Day 0 up to Month 6 after vaccination
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
From Day 0 up to Month 6 after vaccination

Mitarbeiter und Ermittler

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

Sponsor

GlaxoSmithKline

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

Nützliche Links

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 (Tatsächlich)

5. Juni 2007

Primärer Abschluss (Tatsächlich)

26. Februar 2008

Studienabschluss (Tatsächlich)

26. März 2008

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Mai 2007

Zuerst gepostet (Schätzen)

16. Mai 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. November 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. November 2019

Zuletzt verifiziert

1. November 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 109670
  • 2006-006580-23 (EudraCT-Nummer)

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.

IPD-Sharing-Zeitrahmen

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD-Sharing-Zugriffskriterien

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Studiendaten/Dokumente

  1. Kommentiertes Fallberichtsformular
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Einwilligungserklärung
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistischer Analyseplan
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studienprotokoll
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinischer Studienbericht
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Einzelner Teilnehmerdatensatz
    Informationskennung: 109670
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datensatzspezifikation
    Informationskennung: 109670
    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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