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Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

23. Oktober 2017 aktualisiert von: GlaxoSmithKline

Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.

No additional subjects will be recruited during this long-term follow-up.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.

The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

135

Phase

  • Phase 4

Kontakte und Standorte

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

Studienorte

  • Belgien
      • Wilrijk, Belgien, 2610
        • 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

29 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subjects who had received at least one dose of the study vaccine in the primary study
  • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Havrix Group
Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Biologisch: Havrix™
2 doses at 12 months interval

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Zeitfenster: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Seropositive Subjects Against Hepatitis A Virus
Zeitfenster: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Zeitfenster: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Please note that value 14.9 means <15.
Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
Number of Subjects Reporting Solicited Local Symptoms
Zeitfenster: During the 4-day (Days 0-3) follow-up period after additional vaccination
Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Solicited General Symptoms
Zeitfenster: During the 4-day (Days 0-3) follow-up period after additional vaccination

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.

4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Zeitfenster: During the 30-day follow-up period after additional vaccination

An AE is 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.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
Zeitfenster: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
Zeitfenster: During the 30-day follow-up period after additional vaccination

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Pregnancies After Additional Vaccination
Zeitfenster: At Months 186 and 198
The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
At Months 186 and 198

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

1. Januar 2004

Primärer Abschluss (Tatsächlich)

1. März 2013

Studienabschluss (Tatsächlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

14. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Februar 2006

Zuerst gepostet (Schätzen)

15. Februar 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. November 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Oktober 2017

Zuletzt verifiziert

1. Januar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 100571 (M138)
  • 100572 (M150) (Andere Kennung: GSK)
  • 100573 (M162) (Andere Kennung: GSK)
  • 100574 (M174) (Andere Kennung: GSK)
  • 100575 (M186) (Andere Kennung: GSK)
  • 110677 (M198) (Andere Kennung: GSK)
  • 110678 (M210) (Andere Kennung: GSK)
  • 110679 (Andere Kennung: GSK)
  • 110680 (Andere Kennung: GSK)
  • 110681 (Andere Kennung: GSK)

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. Einzelner Teilnehmerdatensatz
    Informationskennung: 100571 (M138)
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study
  2. Einwilligungserklärung
    Informationskennung: 100571 (M138)
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Studienprotokoll
    Informationskennung: 100571 (M138)
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datensatzspezifikation
    Informationskennung: 100571 (M138)
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinischer Studienbericht
    Informationskennung: 100571 (M138)
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistischer Analyseplan
    Informationskennung: 100571 (M138)
    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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