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Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

18. September 2018 aktualisiert von: GlaxoSmithKline

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

957

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

  • China
      • Mengshan Town, China
        • GSK Investigational Site
    • Guangxi
      • Wuzhou, Guangxi, China
        • 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 2 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
  • Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
  • Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
  • 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.
  • Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.

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
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
Biologisch: PoliorixTM
Single dose, intramuscular administration
Biologisch: Infanrix+Hib
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
Aktiver Komparator: Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
Biologisch: Infanrix+Hib
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Zeitfenster: One month after Poliorix™ booster vaccination.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
One month after Poliorix™ booster vaccination.
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Zeitfenster: Before booster vaccination.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Before booster vaccination.
Antibody Titers Against Poliovirus Type 1, 2 and 3
Zeitfenster: One month after Poliorix™ booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
One month after Poliorix™ booster vaccination.
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Zeitfenster: Before booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Before booster vaccination.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Zeitfenster: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.
Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Zeitfenster: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) >39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.
Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Zeitfenster: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Zeitfenster: During the entire study period (Day 0 to Month 1).
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
During the entire study period (Day 0 to Month 1).

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

25. April 2011

Primärer Abschluss (Tatsächlich)

19. September 2011

Studienabschluss (Tatsächlich)

19. September 2011

Studienanmeldedaten

Zuerst eingereicht

24. März 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. März 2011

Zuerst gepostet (Schätzen)

25. März 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Februar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. September 2018

Zuletzt verifiziert

1. Mai 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 114306

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: 114306
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Einzelner Teilnehmerdatensatz
    Informationskennung: 114306
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinischer Studienbericht
    Informationskennung: 114306
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Einwilligungserklärung
    Informationskennung: 114306
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistischer Analyseplan
    Informationskennung: 114306
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studienprotokoll
    Informationskennung: 114306
    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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