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A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

12. April 2016 aktualisiert von: Sanofi Pasteur, a Sanofi Company

Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

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

Intervention / Behandlung

Detaillierte Beschreibung

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

474

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

  • Vereinigte Staaten
    • Florida
      • Miami Beach, Florida, Vereinigte Staaten, 33141
    • Georgia
      • Marietta, Georgia, Vereinigte Staaten, 30062
      • Woodstock, Georgia, Vereinigte Staaten, 30189
    • Kentucky
      • Crestview Hills, Kentucky, Vereinigte Staaten, 41017
      • Louisville, Kentucky, Vereinigte Staaten, 40291
      • Maddisonville, Kentucky, Vereinigte Staaten, 42431
    • Louisiana
      • Metairie, Louisiana, Vereinigte Staaten, 70006
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89104
    • New York
      • Rochester, New York, Vereinigte Staaten, 14609
    • Pennsylvania
      • Hermitage, Pennsylvania, Vereinigte Staaten, 16148
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15237
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15241
    • Rhode Island
      • Cranston, Rhode Island, Vereinigte Staaten, O2920
    • South Carolina
      • Barnwell, South Carolina, Vereinigte Staaten, 29812
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705
      • Fort Worth, Texas, Vereinigte Staaten, 76135
      • San Angelo, Texas, Vereinigte Staaten, 76904
    • Utah
      • Orem, Utah, Vereinigte Staaten, 84057
      • South Jordan, Utah, Vereinigte Staaten, 84095
      • Springville, Utah, Vereinigte Staaten, 84663

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

6 Monate bis 9 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria :

All subjects:

  • Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures

Subjects aged 3 to 9 years:

  • Healthy children aged 3 to 9 years on the day of inclusion

Subjects aged 6 to 35 months:

  • Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Exclusion Criteria :

  • 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 surface 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
  • 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.
  • Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
  • 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
  • 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

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
Biologisch: Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
Biologisch: Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Biologisch: Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
Biologisch: Monovalent Subvirion A/H1N1 Influenza vaccine
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Placebo-Komparator: Placebo Group
Participants will receive a placebo vaccine
Biologisch: Normal saline solution (placebo)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

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 6 to 35 Months
Zeitfenster: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre- 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 6 to 35 Months
Zeitfenster: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer of ≥ 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 6 to 35 Months
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 Vaccine) Strain - Age 3 to 9 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 3 to 9 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 3 to 9 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 At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Zeitfenster: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
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.
Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 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.
Days 0 to 7 post vaccination

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. Juni 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)

14. April 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. April 2016

Zuletzt verifiziert

1. April 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FUF15
  • UTN: U1111-1111-4713

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