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Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

5. oktober 2011 opdateret af: St. Jude Children's Research Hospital
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review.

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

104

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • St.Jude Children's Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care. Stem cell transplant recipients in the first year following their transplant are excluded.

Beskrivelse

Inclusion Criteria:

  • Age 6 months through 21 years of age at the time of entry into the study;
  • Body weight of 13 kg or greater at the time of entry into the study;
  • Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant;
  • Participant or participant's parent/legal guardian available by telephone during the course of the study;
  • Written informed consent (and assent, if applicable) obtained;
  • Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry.

Exclusion Criteria:

  • Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry;
  • Receipt of a stem cell transplant within one year prior to study entry;
  • Participation in P1088 study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
H1N1 pandemic influenza vaccine recipient
Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40).
Tidsramme: 1.5 years
1.5 years

Sekundære resultatmål

Resultatmål
Tidsramme
This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera).
Tidsramme: 1.5 years
1.5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Jude Children's Research Hospital

Efterforskere

  • Ledende efterforsker: Hana Hakim, MD, St. Jude Children'S Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

19. oktober 2009

Først indsendt, der opfyldte QC-kriterier

22. oktober 2009

Først opslået (Skøn)

23. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. oktober 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2011

Sidst verificeret

1. oktober 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • SOVAC

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med H1N1 Pandemic Flu

Søg i lignende forsøg

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner