- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02601040
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
6. november 2015 opdateret af: Jiangsu Province Centers for Disease Control and Prevention
Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult
The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
13500
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Jiangsu
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Nanjing, Jiangsu, Kina, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
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Yunnan
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Kunming, Yunnan, Kina, 650118
- Institute of Medical Biology -Chinese Academy of Medical Sciences
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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
1 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Only subjects fulfilling all of the following criteria will be eligible for the study:
- People aged from 18 months to 65 years old.
- The subjects or subjects' guardians are able to understand and sign the informed consent
- The subjects or subjects' guardians allow to comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
- The subjects have signed informed consent already
Exclusion Criteria:
- Subjects will not be eligible for the study if any of the following criteria is met:
- Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
- Have a history of neurological symptoms or signs
- Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
- Suffering from serious chronic diseases
- Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
- Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
- Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
- Any prior diseases including human immunodeficiency virus infection or related
- Bleeding constitution or prolong bleeding time situation
- Accept hepatitis A vaccination within a month
- Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
- People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
- Caught a fever with axillary temperature 38°C or higher in past 3 days
- Take part in another clinical researchers
- 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
- Pregnancy test result is positive
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Attenuated Hepatitis A Vaccine, H2 Strain
Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.
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6.50 lgCCID50/ml in babies aged 18-35 months\6.50
lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old
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Eksperimentel: Inactivated Hepatitis A Vaccine, Lu8 Strain
Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.
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320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose
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Placebo komparator: Group A Meningococcal Polysaccharide vaccine
Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.
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30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes of hepatitis A antibody concentration
Tidsramme: 37 months
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Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
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37 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of adverse events
Tidsramme: 28 days
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Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.
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28 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Jingsi Yang, PhD, Institude of Medical Biology, Chinese Academy of Medical Sciences
- Ledende efterforsker: Qiangming Sun, PhD, Institude of Medical Biology, Chinese Academy of Medical Sciences
- Ledende efterforsker: Guodong Kang, Jiangsu Provincial Center for Disease Control and Prevention
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.
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 2011
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først indsendt
25. oktober 2015
Først indsendt, der opfyldte QC-kriterier
6. november 2015
Først opslået (Skøn)
10. november 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. november 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JSEPI-004
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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