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Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

22. august 2011 opdateret af: Sanofi

Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

882

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
      • Layton, UT 84041, Georgia, Forenede Stater, 30062
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
    • Massachusetts
      • Woburn, Massachusetts, Forenede Stater, 01801
    • Missouri
      • Bridgeton, Missouri, Forenede Stater, 63044
      • St. Louis, Missouri, Forenede Stater, 63141
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
    • New York
      • Rochester, New York, Forenede Stater, 14620
      • Syracuse, New York, Forenede Stater, 13210
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
      • Cincinnati, Ohio, Forenede Stater, 45229
      • Columbus, Ohio, Forenede Stater, 43205
      • University Heights, Ohio, Forenede Stater, 44118
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15241
      • Sellersville, Pennsylvania, Forenede Stater, 18960
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
    • Utah
      • Layton, Utah, Forenede Stater, 84041
      • Ogden, Utah, Forenede Stater, 84405
      • Pleasant Grove, Utah, Forenede Stater, 84062
      • Provo, Utah, Forenede Stater, 84604
      • Salt Lake City, Utah, Forenede Stater, 84123
      • South Jordan, Utah, Forenede Stater, 84095
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23510
    • Washington
      • Spokane, Washington, Forenede Stater, 99220

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

4 år til 7 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy, as determined by medical history and physical examination.
  • Aged 4 to < 7 years at the time of study vaccination on Day 0.
  • Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
  • Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Exclusion Criteria:

  • Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
  • Known or suspected impairment of immunologic function
  • Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
  • History of documented invasive meningococcal disease or previous meningococcal vaccination
  • Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
  • Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
  • Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
  • Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
  • Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
  • Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
  • Enrolled in another clinical trial.
  • Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  • Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
  • Personal or family history of Guillain-Barré Syndrome (GBS).

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Eksperimentel: Group 2
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Eksperimentel: Group 3
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL
Biologisk: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Andre navne:
  • Menactra®
  • DAPTACEL®
  • IPOL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Tidsramme: Day 30 post-vaccination (Visit 1)
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Day 30 post-vaccination (Visit 1)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Tidsramme: Day 30 post-vaccination (Visit 1)
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Day 30 post-vaccination (Visit 1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Tidsramme: Day 30 post-vaccination 1
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Tidsramme: Day 30 post-vaccination
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Tidsramme: Day 0 through Day 7 post-vaccination at Visit 1
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Day 0 through Day 7 post-vaccination at Visit 1

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Tidsramme: Day 30 post-vaccination
Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.
Day 30 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Tidsramme: Day 0 through Day 7 post-vaccination
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Day 0 through Day 7 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Tidsramme: Day 0 through Day 7 post-vaccination
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Day 0 through Day 7 post-vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

Sanofi

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. oktober 2006

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juli 2009

Datoer for studieregistrering

Først indsendt

20. juli 2006

Først indsendt, der opfyldte QC-kriterier

20. juli 2006

Først opslået (Skøn)

21. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2011

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MTA43

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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