- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01256515
Health Management Training to Enhance Influenza Vaccine Immunogenicity
28. maj 2013 opdateret af: John W. Denninger, MD, PhD, Massachusetts General Hospital
The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management trainings.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We will obtain preliminary data on the time it takes to achieve a protective immune response, durability of response and occurrence of influenza in the following influenza season.
Promising results in this age group will provide preliminary data for expanded future studies in the elderly.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Benson-Henry Institute, 151 Merrimac St, 4th Floor
-
-
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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
General Inclusion criteria are the following:
- age 50 years or older
- Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-hepatitis C virus (HCV)
- Routine Laboratory tests
- able and willing to complete the informed consent process
- able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
General Exclusion criteria
- self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV
- self-reported vaccination with the seasonal influenza vaccine for the current 2010-2011 influenza season (vaccination with the H1N1 influenza vaccine before, during, or after the study will not be exclusionary)
- history of hypersensitivity to any influenza vaccine components including thimerosal or egg
- history of Guillain-Barre syndrome
- self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins (IL), corticosteroids (oral or inhaled)), G(M)- cerebrospinal fluid (CSF)) in 4 weeks before enrollment or self reported history of IL-2 administration within 5 years
- self-reported use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination
- any clinically significant abnormalities found during a routine physical examination
- self-reported history of any autoimmune disease
- acute febrile illness on the day of intended immunization - immunization deferred until illness resolved
- self report of current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits (such as severe attention deficit hyperactivity disorder (ADHD) and current major depressive episode)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Health Education Training Group 1
One form of health education training
|
CDs, techniques, advice, and group training pertaining to a healthier lifestyle.
Both groups will have this intervention, but the specific type of health education training will vary between groups.
8 weeks of group training regarding health education techniques.
|
|
Aktiv komparator: Health Education Training Group 2
Another form of health education training
|
CDs, techniques, advice, and group training pertaining to a healthier lifestyle.
Both groups will have this intervention, but the specific type of health education training will vary between groups.
8 weeks of group training regarding health education techniques.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Immunoglobin antibody response
Tidsramme: pre and post following 8 weeks of health management training
|
pre and post following 8 weeks of health management training
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John Denninger, M.D., Ph.D., Massachusetts General Hospital
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. november 2009
Primær færdiggørelse (Faktiske)
1. september 2011
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
7. december 2010
Først indsendt, der opfyldte QC-kriterier
7. december 2010
Først opslået (Skøn)
8. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2009P001437
- 5R01DP000339 (U.S. NIH-bevilling/kontrakt)
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 .
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