A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
6. Februar 2014 aktualisiert von: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
849
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Alabama
-
Hoover, Alabama, Vereinigte Staaten, 35216
-
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Arizona
-
Chandler, Arizona, Vereinigte Staaten, 85224
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Phoenix, Arizona, Vereinigte Staaten, 85020
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-
California
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Anaheim, California, Vereinigte Staaten
-
-
Florida
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South Miami, Florida, Vereinigte Staaten, 33143
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Kentucky
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Maddisonville, Kentucky, Vereinigte Staaten, 42431
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Missouri
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Springfield, Missouri, Vereinigte Staaten, 65802
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North Carolina
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Raleigh, North Carolina, Vereinigte Staaten, 27612
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45227
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Cleveland, Ohio, Vereinigte Staaten, 44122
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South Carolina
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Mt. Pleasant, South Carolina, Vereinigte Staaten, 29464
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37920
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Texas
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Austin, Texas, Vereinigte Staaten, 78705
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84124
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23507
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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
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria :
- Healthy adults aged 18 years or older on the day of inclusion
- Informed consent has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Exclusion Criteria :
- Known pregnancy or positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
- Previous participation in a swine-origin H1N1 pandemic flu trial except if performed in 1976
- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
- Personal or family history of Guillain-Barré syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
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: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
|
0.5 mL, Intramuscular on Day 0 and on Day 21
|
|
Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
|
0.5 mL, Intramuscular on Day 0 and Day 21
|
|
Placebo-Komparator: Placebo Group
Participants will receive a placebo vaccine
|
0.5 mL, Intramuscular on Day 0 and Day 21
|
|
Experimental: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 Vaccine formulation 3
|
0.5 mL, Intramuscular on Day 0 and day 21
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Zeitfenster: Pre-vaccination (Day 0) and day 21 post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and day 21 post-vaccination
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Zeitfenster: Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and Day 21 post-vaccination
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Zeitfenster: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Zeitfenster: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Zeitfenster: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Zeitfenster: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Zeitfenster: Days 0 to 7 post-vaccination
|
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
|
Days 0 to 7 post-vaccination
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Zeitfenster: Days 0 to 7 post-vaccination
|
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
|
Days 0 to 7 post-vaccination
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
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Nützliche Links
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. August 2009
Primärer Abschluss (Tatsächlich)
1. März 2010
Studienabschluss (Tatsächlich)
1. Dezember 2010
Studienanmeldedaten
Zuerst eingereicht
3. August 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. August 2009
Zuerst gepostet (Schätzen)
6. August 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
10. März 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Februar 2014
Zuletzt verifiziert
1. Februar 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FUF14
- UTN: U1111-1111-4798 (Andere Kennung: WHO)
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