- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01819155
Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa
18. oktober 2013 opdateret af: PATH
Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal
This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children.
This data will inform future policy considerations for influenza vaccine.
The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal.
A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo.
Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart.
Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two.
For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two.
Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
296
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Niakhar, Senegal
- Institut de Recherche pour le Developpement
-
-
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 5 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
- Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Exclusion Criteria:
- Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
- Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
- Previous receipt of any influenza vaccine.
- Hypersensitivity after previous administration of any vaccine.
- Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.
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 |
|---|---|
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Eksperimentel: adjTIV
Children randomized to receive adjTIV
|
Andre navne:
|
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Eksperimentel: TIV
Children randomized to receive TIV
|
Andre navne:
|
|
Placebo komparator: Placebo
Children randomized to receive Placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immunogenicity of adjTIV
Tidsramme: 28 days post-dose 2
|
serum hemagglutination-inhibition antibodies
|
28 days post-dose 2
|
|
Immunogenicity of TIV
Tidsramme: 28 days post-dose 2
|
serum hemagglutination-inhibition antibodies
|
28 days post-dose 2
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adverse events
Tidsramme: through three months post-dose 2
|
through three months post-dose 2
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: John C Victor, PhD, MPH, PATH
- Ledende efterforsker: Aldiouma Diallo, MD, Institut de Recherche pour le Developpement
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. april 2013
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. september 2013
Datoer for studieregistrering
Først indsendt
22. marts 2013
Først indsendt, der opfyldte QC-kriterier
22. marts 2013
Først opslået (Skøn)
27. marts 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. oktober 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. oktober 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MF59-TIV-SEN-01
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 .