- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00772070
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.
Primary Objective:
To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arkansas
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Jonesboro, Arkansas, Förenta staterna, 72401
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Little Rock, Arkansas, Förenta staterna, 72211
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Massachusetts
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Woburn, Massachusetts, Förenta staterna, 01801
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Missouri
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Bridgeton, Missouri, Förenta staterna, 63044
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New York
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Rochester, New York, Förenta staterna, 14620
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15241
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Sellersville, Pennsylvania, Förenta staterna, 18960
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Virginia
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Norfolk, Virginia, Förenta staterna, 23501
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria :
- Stage I
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the enrolment.
- For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
- For the Control group: no previous history of any meningococcal vaccination
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
- Stage II
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1.
- Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1.
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
Exclusion Criteria :
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 99.5ºF [≥ 37.5ºC]) at the time of inclusion
- For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02.
- For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
- Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six 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 vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn
- Received any vaccine in the 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
- Suspected or known hypersensitivity to any of the vaccine components
- 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
- Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Previously received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
0.05 mL, Subcutaneous
Andra namn:
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Experimentell: Meningococcal vaccine-naїve
Participants have never received a Meningococcal vaccine in the past.
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0.05 mL, Subcutaneous
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Tidsram: Day 0 and Days 8 and 28 post-vaccination
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Day 0 and Days 8 and 28 post-vaccination
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Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Tidsram: Baseline to Day 8 and Day 28 post-vaccination
|
Baseline to Day 8 and Day 28 post-vaccination
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Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Tidsram: Day 0 to 7 post-vaccination
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Day 0 to 7 post-vaccination
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-positiva bakteriella infektioner
- Actinomycetales infektioner
- Corynebacterium-infektioner
- Difteri
- Hjärnhinneinflammation
- Läkemedels fysiologiska effekter
- Immunologiska faktorer
- Vacciner
Andra studie-ID-nummer
- MTA17
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