- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23510
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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:
|
Experimental: 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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GRC40
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