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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

135

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Wilrijk, België, 2610
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

29 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2004

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

14 februari 2006

Eerst ingediend dat voldeed aan de QC-criteria

14 februari 2006

Eerst geplaatst (Schatting)

15 februari 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 november 2017

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Gegevensset individuele deelnemers
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: 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. Formulier geïnformeerde toestemming
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Leerprotocool
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specificatie gegevensset
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisch onderzoeksrapport
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisch analyseplan
    Informatie-ID: 100571 (M138)
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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