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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 aprile 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Effettivo)

474

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 9 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
Biologico: 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)
Biologico: 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)
Sperimentale: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Biologico: 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)
Biologico: 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)
Comparatore placebo: Placebo Group
Participants will receive a placebo vaccine
Biologico: 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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi Pasteur, a Sanofi Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2009

Completamento primario (Effettivo)

1 marzo 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

3 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2009

Primo Inserito (Stima)

6 agosto 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 aprile 2016

Ultimo verificato

1 aprile 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FUF15
  • UTN: U1111-1111-4713

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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