Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
21. januar 2014 opdateret af: Sanofi Pasteur, a Sanofi Company
Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.
Primary Objective:
To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to <6 years of age.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Biologisk: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisk: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisk: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisk: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisk: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisk: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Detaljeret beskrivelse
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
378
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
-
-
Connecticut
-
Norwich, Connecticut, Forenede Stater, 06360
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
-
Marietta, Georgia, Forenede Stater, 30062
-
-
Kentucky
-
Bardstown, Kentucky, Forenede Stater, 40004
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
-
-
Massachusetts
-
Woburn, Massachusetts, Forenede Stater, 01801
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44308
-
Columbus, Ohio, Forenede Stater, 43205
-
-
Pennsylvania
-
Drexel Hill, Pennsylvania, Forenede Stater, 19026
-
Pittsburg, Pennsylvania, Forenede Stater, 15241
-
Sellersville, Pennsylvania, Forenede Stater, 18960
-
-
Tennessee
-
Kingsport, Tennessee, Forenede Stater, 37664
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84123
-
-
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
9 måneder til 5 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria :
- Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
- Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria :
- History of a serious chronic disease that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
- History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
- Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
- Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
- Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- Unable to attend one or more of the scheduled visits or to comply with the study procedures.
- Participation in another clinical trial in the 4 weeks preceding enrollment.
- Planned participation in another clinical trial during the present trial period.
- 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.
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: Vaccinated at Age 9 and 12 Months
Participants received Menactra® vaccine at 9 and 12 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Andre navne:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 18 months)
Andre navne:
|
|
Eksperimentel: Vaccinated at Age 9 and 15 Months
Participants received Menactra® vaccine at 9 and 15 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Andre navne:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 18 months)
Andre navne:
|
|
Eksperimentel: Vaccinated at Age 12 and 15 Months
Participants received Menactra® vaccine at Age 12 and 12 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Andre navne:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 18 months)
Andre navne:
|
|
Eksperimentel: Vaccinated at Age 15 Months
Participants received Menactra® vaccine at 15 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Andre navne:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 18 months)
Andre navne:
|
|
Eksperimentel: Vaccinated at Age 18 Months
Participants received Menactra® vaccine at 18 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Andre navne:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 15 months)
Andre navne:
0.5 mL, Intramuscular (at age 18 months)
Andre navne:
|
|
Aktiv komparator: Vaccinated at Age 3 Years to <6 Years
Participants received Menomune® vaccine at Age 3 years to <6 years of age
|
0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Tidsramme: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
|
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Tidsramme: Day 0 up to 7 post-vaccination
|
Solicited local reactions: Redness, Swelling, and Tenderness.
Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
|
Day 0 up to 7 post-vaccination
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. december 2004
Primær færdiggørelse (Faktiske)
1. marts 2006
Studieafslutning (Faktiske)
1. oktober 2007
Datoer for studieregistrering
Først indsendt
24. marts 2008
Først indsendt, der opfyldte QC-kriterier
25. marts 2008
Først opslået (Skøn)
26. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Infektioner
- Gram-negative bakterielle infektioner
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Actinomycetales infektioner
- Corynebacterium infektioner
- Neisseriaceae infektioner
- Difteri
- Meningitis
- Meningokokinfektioner
Andre undersøgelses-id-numre
- MTA26
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 .