- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00391391
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.
Primary Objective:
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Secondary Objectives:
- To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
- To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Biologisk: Split, Inactivated, Trivalent Influenza Vaccine
- Biologisk: Split, Inactivated, Trivalent Influenza Vaccine
- Biologisk: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
- Biologisk: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arkansas
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Harrisburg, Arkansas, Förenta staterna, 72432
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Little Rock, Arkansas, Förenta staterna, 72205
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Trumann, Arkansas, Förenta staterna, 72472
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California
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Bellflower, California, Förenta staterna, 90706
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Downey, California, Förenta staterna, 90241
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Fountain Valley, California, Förenta staterna, 92708
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Paramount, California, Förenta staterna, 90723
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Kentucky
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Owensboro, Kentucky, Förenta staterna, 42303
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Louisiana
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Bossier City, Louisiana, Förenta staterna, 71111
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Shreveport, Louisiana, Förenta staterna, 71105
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Minnesota
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Brainerd, Minnesota, Förenta staterna, 56401
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Ohio
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Cleveland, Ohio, Förenta staterna, 44121
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Pennsylvania
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Erie, Pennsylvania, Förenta staterna, 16505
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Pittsburgh, Pennsylvania, Förenta staterna, 15277
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Uniontown, Pennsylvania, Förenta staterna, 15401
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Wexford, Pennsylvania, Förenta staterna, 15090
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Texas
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Fort Worth, Texas, Förenta staterna, 76107
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Utah
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Salt Lake City, Utah, Förenta staterna, 84121
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Salt Lake City, Utah, Förenta staterna, 84109
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria :
- Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
- Subject is healthy, as determined by medical history.
- Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
- Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.
Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal or family history of Guillain-Barré Syndrome.
- 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 injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion
- Received blood or blood-derived products in the previous 3 months.
- Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
- Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
- History of seizures.
- Received antibiotics therapy within 72 hours preceding the trial vaccination.
- Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
- Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Split, Inactivated, Trivalent Influenza Vaccine
|
Vaccine (infant dose)
Vaccine (children dose)
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Experimentell: 2
Split, Inactivated, Trivalent Influenza Vaccine
|
Vaccine (infant dose)
Vaccine (children dose)
|
Aktiv komparator: 3
Split, Inactivated, Trivalent Influenza Vaccine
|
Vaccine (infant dose)
Andra namn:
Vaccine (children dose)
Andra namn:
|
Aktiv komparator: 4
Split, Inactivated, Trivalent Influenza Vaccine
|
Vaccine (infant dose)
Andra namn:
Vaccine (children dose)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Tidsram: Day 0 and Day 28 post-vaccination
|
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
|
Day 0 and Day 28 post-vaccination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Tidsram: Day 28 post-vaccination
|
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
|
Day 28 post-vaccination
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Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Tidsram: Day 28 post-vaccination
|
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique. |
Day 28 post-vaccination
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Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Tidsram: Day 28 post-vaccination
|
Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
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Day 28 post-vaccination
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Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Tidsram: Day 0 to Day 7 post-vaccination
|
Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis.
Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
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Day 0 to Day 7 post-vaccination
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Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Tidsram: Day 0 to Day 7 post-vaccination
|
Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis.
Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
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Day 0 to Day 7 post-vaccination
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FID07
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