- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02212106
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
20. September 2015 aktualisiert von: Seqirus
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years.
Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
402
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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Los Angeles, California, Vereinigte Staaten, 90036
- Site 286
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Idaho
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Boise, Idaho, Vereinigte Staaten, 83642
- Site 289
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63141
- Site 287
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New York
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Binghamton, New York, Vereinigte Staaten, 13901
- Site 285
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27704
- Site 290
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Raleigh, North Carolina, Vereinigte Staaten, 27609
- Site 281
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Winston-Salem, North Carolina, Vereinigte Staaten, 27103
- Site 280
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29403
- Site 284
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Texas
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Austin, Texas, Vereinigte Staaten, 78705
- Site 283
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Fort Worth, Texas, Vereinigte Staaten, 76135
- Site 282
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San Angelo, Texas, Vereinigte Staaten, 76904
- Site 288
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
5 Jahre bis 8 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria:
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
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Aktiver Komparator: Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
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Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
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7 days after each administration of vaccine.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom.
Excludes subjects with missing intensity information for the whole 7 days.
Mild fever: ≥ 100.4 to < 101.3º
F (≥ 38.0 to < 38.5º C).
Moderate fever: ≥ 101.3 to < 102.2º
F (≥ 38.5 to < 39.0º C).
Severe fever: ≥ 102.2º
F (≥ 39.0º C).
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
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7 days after each administration of vaccine.
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The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality.
However, subjects can be counted more than once overall.
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7 days after each administration of vaccine.
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The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Zeitfenster: 7 days after each administration of vaccine.
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The number of subjects experiencing at least one SAE.
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7 days after each administration of vaccine.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: bioCSL Pty Ltd Clinical Program Director, Seqirus
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2014
Primärer Abschluss (Tatsächlich)
1. Dezember 2014
Studienabschluss (Tatsächlich)
1. Dezember 2014
Studienanmeldedaten
Zuerst eingereicht
6. August 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. August 2014
Zuerst gepostet (Schätzen)
8. August 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
16. Oktober 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. September 2015
Zuletzt verifiziert
1. September 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CSLCT-USF-10-69
- 2015-000175-27 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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