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Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older

12. august 2016 opdateret af: Beijing Chaoyang District Centre for Disease Control and Prevention
This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after 7 days.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100021
        • DongBa clinical center

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

3 år til 60 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
  • the subjects and his guardians can obey the demands of the scheme .
  • Axillary temperature less than 37℃

Exclusion Criteria:

  • The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs,ovalbumin etc.
  • The people who has serious side effects to vaccine, such as allergy,urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
  • the subject who has symptoms of acute infection within a week.
  • Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
  • People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
  • People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
  • Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
  • people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
  • alienia, functional asplenia, and alienia or splenectomy in any situation.
  • Serious neurological disorders such as Green Barry syndrome.
  • people who has received blood products or immunoglobulin products in the past one months.
  • people who has received other study drug in the past one month.
  • people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
  • people who has received allergy treatment in in the past 14 days.
  • People who is on anti-TB treatment.
  • People whose axillary temperature is more than 37℃ before the vaccination.
  • People who is pregnant.
  • Any factors unsuitable for clinical trail according to the researchers.

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: One dose Vaccine in aged 18-60 years old
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.
Biologisk: En dosis Quadrivalent Influenza Virus Vaccine
Eksperimentel: One dose Vaccine in aged 3-17 years old
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 years old.
Biologisk: En dosis Quadrivalent Influenza Virus Vaccine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
Tidsramme: 3 months
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention

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. marts 2016

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

10. marts 2016

Først indsendt, der opfyldte QC-kriterier

10. marts 2016

Først opslået (Skøn)

15. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • cycdc2015-5

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 Quadrivalent influenzavirusvaccine

Kliniske forsøg med En dosis Quadrivalent Influenza Virus Vaccine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Australia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner