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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

882

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 7 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 navn:
  • 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 navn:
  • 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 navn:
  • Menactra®
  • DAPTACEL®
  • IPOL
Eksperimentell: 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 navn:
  • 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 navn:
  • 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 navn:
  • Menactra®
  • DAPTACEL®
  • IPOL
Eksperimentell: 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 navn:
  • 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 navn:
  • 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 navn:
  • Menactra®
  • DAPTACEL®
  • IPOL

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2006

Primær fullføring (Faktiske)

1. juni 2009

Studiet fullført (Faktiske)

1. juli 2009

Datoer for studieregistrering

Først innsendt

20. juli 2006

Først innsendt som oppfylte QC-kriteriene

20. juli 2006

Først lagt ut (Anslag)

21. juli 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. august 2011

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MTA43

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