- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01040078
Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
29. december 2009 opdateret af: Centers for Disease Control and Prevention, China
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
900
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Guangxi
-
Guilin, Guangxi, Kina, 541000
- Rekruttering
- Lingchuan County CDC
-
Kontakt:
- Yanping Li, Doctor
- Telefonnummer: 0773 6812175
- E-mail: lyp898@163.com
-
-
Hunan
-
Xiangxi Prefecture, Hunan, Kina, 416100
- Rekruttering
- Luxi County CDC
-
Kontakt:
- Fangjun Li, Doctor
- Telefonnummer: 0743 4265397
- E-mail: fangjunliself678@sina.com
-
-
Jiangsu
-
Yancheng, Jiangsu, Kina, 224001
- Rekruttering
- Yandu District CDC
-
Kontakt:
- Yuemei Hu, Doctor
- Telefonnummer: 0515 8324084
- E-mail: 993832717@qq.com
-
-
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 2 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
- Family members of the employees or the Investigator
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- Confirmed infection with the novel influenza A/H1N1 strain
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
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: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 7.5ug H1N1 vaccine
360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.
|
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
Eksperimentel: 15ug H1N1 vaccine
360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.
|
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
Placebo komparator: seasonal influenza vaccine
180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.
|
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. december 2009
Primær færdiggørelse (Forventet)
1. februar 2010
Studieafslutning (Forventet)
1. juni 2010
Datoer for studieregistrering
Først indsendt
24. december 2009
Først indsendt, der opfyldte QC-kriterier
24. december 2009
Først opslået (Skøn)
25. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. december 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. december 2009
Sidst verificeret
1. december 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20090601
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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