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Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

12. april 2016 opdateret af: Sanofi Pasteur, a Sanofi Company

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 5 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Primed
Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
Biologisk: Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Andre navne:
  • Fluzone®
Eksperimentel: Group 2: Naive/Inadequately Primed
Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
Biologisk: Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Andre navne:
  • Fluzone®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

16. september 2008

Først indsendt, der opfyldte QC-kriterier

16. september 2008

Først opslået (Skøn)

18. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GRC40

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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