Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
21. januar 2014 opdateret af: Sanofi Pasteur, a Sanofi Company
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This was a two stage, controlled, open-label trial.
Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
173
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72401
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Little Rock, Arkansas, Forenede Stater, 72211
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Massachusetts
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Woburn, Massachusetts, Forenede Stater, 01801
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Missouri
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Bridgeton, Missouri, Forenede Stater, 63044
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New York
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Rochester, New York, Forenede Stater, 14620
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15241
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Sellersville, Pennsylvania, Forenede Stater, 18960
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Virginia
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Norfolk, Virginia, Forenede Stater, 23501
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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
3 år til 5 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
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 |
|---|---|
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Eksperimentel: Previously received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
0.05 mL, Subcutaneous
Andre navne:
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Eksperimentel: Meningococcal vaccine-naїve
Participants have never received a Meningococcal vaccine in the past.
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0.05 mL, Subcutaneous
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Tidsramme: Baseline to Day 8 and Day 28 post-vaccination
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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.
Tidsramme: Day 0 to 7 post-vaccination
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Day 0 to 7 post-vaccination
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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. marts 2003
Primær færdiggørelse (Faktiske)
1. august 2003
Studieafslutning (Faktiske)
1. maj 2004
Datoer for studieregistrering
Først indsendt
13. oktober 2008
Først indsendt, der opfyldte QC-kriterier
14. oktober 2008
Først opslået (Skøn)
15. oktober 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
Yderligere relevante MeSH-vilkår
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Infektioner
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Actinomycetales infektioner
- Corynebacterium infektioner
- Difteri
- Meningitis
- Lægemidlers fysiologiske virkninger
- Immunologiske faktorer
- Vacciner
Andre undersøgelses-id-numre
- MTA17
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