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- Klinische proef NCT00643916
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Biologisch: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisch: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisch: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisch: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisch: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biologisch: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
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Connecticut
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Norwich, Connecticut, Verenigde Staten, 06360
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
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Marietta, Georgia, Verenigde Staten, 30062
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
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Massachusetts
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Woburn, Massachusetts, Verenigde Staten, 01801
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Ohio
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Akron, Ohio, Verenigde Staten, 44308
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Columbus, Ohio, Verenigde Staten, 43205
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Pennsylvania
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Drexel Hill, Pennsylvania, Verenigde Staten, 19026
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Pittsburg, Pennsylvania, Verenigde Staten, 15241
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Sellersville, Pennsylvania, Verenigde Staten, 18960
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Tennessee
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Kingsport, Tennessee, Verenigde Staten, 37664
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84123
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Vaccinated at Age 9 and 12 Months
Participants received Menactra® vaccine at 9 and 12 Months of age
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0.5 mL, Intramuscular (at age 9 and 12 months)
Andere namen:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 18 months)
Andere namen:
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Experimenteel: Vaccinated at Age 9 and 15 Months
Participants received Menactra® vaccine at 9 and 15 Months of age
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0.5 mL, Intramuscular (at age 9 and 12 months)
Andere namen:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 18 months)
Andere namen:
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Experimenteel: Vaccinated at Age 12 and 15 Months
Participants received Menactra® vaccine at Age 12 and 12 Months of age
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0.5 mL, Intramuscular (at age 9 and 12 months)
Andere namen:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 18 months)
Andere namen:
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Experimenteel: Vaccinated at Age 15 Months
Participants received Menactra® vaccine at 15 Months of age
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0.5 mL, Intramuscular (at age 9 and 12 months)
Andere namen:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 18 months)
Andere namen:
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Experimenteel: Vaccinated at Age 18 Months
Participants received Menactra® vaccine at 18 Months of age
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0.5 mL, Intramuscular (at age 9 and 12 months)
Andere namen:
0.5 mL, Intramuscular (at age 9 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 12 and 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 15 months)
Andere namen:
0.5 mL, Intramuscular (at age 18 months)
Andere namen:
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Actieve vergelijker: Vaccinated at Age 3 Years to <6 Years
Participants received Menomune® vaccine at Age 3 years to <6 years of age
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0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Tijdsspanne: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Tijdsspanne: Day 0 up to 7 post-vaccination
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Solicited local reactions: Redness, Swelling, and Tenderness.
Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
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Day 0 up to 7 post-vaccination
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Infecties
- Gram-negatieve bacteriële infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-positieve bacteriële infecties
- Actinomycetales-infecties
- Corynebacterium-infecties
- Neisseriaceae-infecties
- Difterie
- Meningitis
- Meningokokkeninfecties
Andere studie-ID-nummers
- MTA26
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