- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01736709
The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine
27. maj 2013 opdateret af: Sinovac Biotech Co., Ltd
A Single-centered, Open-labeled, Phase 4 Study of 2012-2013 Trivalent Seasonal Influenza Vaccine
The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
202
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Henan
-
Zhengzhou, Henan, Kina
- Henan Center for Diseases Control and Prevention
-
-
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 85 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
For adults and old people:
Inclusion Criteria:
- Healthy adults aged 18-60 years old, and healthy old people aged >60 years
- Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- Not participate in any other clinical trials during the study
- Not receive any immunosuppressive agents during and one month prior to the study
- Be able to understand and sign the informed consent.
Exclusion Criteria:
- Woman: Who breast-feeding or planning to become pregnant during the study
- Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
- Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
- Guillain-Barre Syndrome
- Women subjects with positive urinary pregnancy test
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- Axillary temperature >37.0 centigrade at the time of dosing
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
For infants:
Inclusion Criteria:
- Healthy male or female aged between 6 and 35 months
- Full-term birth, birth weight 2,500 grams or more
- provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Exclusion Criteria:
- Administration of 2012-2013 seasonal vaccine
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Symptoms of acute infection within a week
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular injections or blood draws
- History or family history of convulsions, epilepsy, brain disease and psychiatric
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- Be receiving anti-Tuberculosis prophylaxis or therapy currently
- Axillary temperature > 37.0 centigrade at the time of dosing
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: trivalent seasonal influenza vaccine
2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen
|
trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine
Tidsramme: 21 days after vaccination
|
to evaluate the immunogenicity of the vaccine in adults and old people.
|
21 days after vaccination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Frequency of systemic and local adverse reactions after vaccination
Tidsramme: 0-21 days after vaccination
|
to evaluate the safety of the vaccine in healthy infants, adults, and old people
|
0-21 days after vaccination
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Wan-Shen Guo, BS, Henan Center for Diseases 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. november 2012
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
26. november 2012
Først indsendt, der opfyldte QC-kriterier
26. november 2012
Først opslået (Skøn)
29. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2013
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO-INF-4012
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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