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- Klinische proef NCT00755274
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
Primary Objective:
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23510
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- History of severe adverse event to any influenza vaccine.
- Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during participation in the study.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay, neurologic disorder, or seizure disorder.
- Chronic medical, congenital, or developmental disorder.
- Known Human immunodeficiency virus (HIV)-positive mother.
- Prior personal history of Guillain-Barré syndrome.
- Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Group 1: Primed
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
|
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Andere namen:
|
Experimenteel: Group 2: Naive/Inadequately Primed
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
|
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Tijdsspanne: Day 0 to Day 3 post-vaccination 1
|
Solicited local reactions: Tenderness, pain, erythema, and swelling.
Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
|
Day 0 to Day 3 post-vaccination 1
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Tijdsspanne: Day 0 to Day 3 post-vaccination 2
|
Solicited local reactions: Tenderness, pain, erythema, and swelling.
Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
|
Day 0 to Day 3 post-vaccination 2
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Tijdsspanne: Day 28 post-single dose or Day 21 post-Dose 2
|
Day 28 post-single dose or Day 21 post-Dose 2
|
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Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Tijdsspanne: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40.
Data presented for all participants and those enrolled at age 6 to 35 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Tijdsspanne: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40.
Data presented for participants enrolled at age 36 to 59 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
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Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Tijdsspanne: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer.
Data presented for all participants and those enrolled at age 6 to 35 months of age.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Tijdsspanne: Day 28 post-single dose or Day 21 post-Dose 2
|
Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer.
Data presented for participants enrolled at age 36 to 59 months.
|
Day 28 post-single dose or Day 21 post-Dose 2
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GRC40
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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