- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
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Virginia
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Norfolk, Virginia, Spojené státy, 23510
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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)
Ostatní jména:
|
Experimentální: 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)
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Časové okno: Day 28 post-single dose or Day 21 post-Dose 2
|
Day 28 post-single dose or Day 21 post-Dose 2
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Časové okno: 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)
Časové okno: 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
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GRC40
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