- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00524732
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Charlottetown, Canada, C1A 7N8
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-
Nova Scotia
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Halifax, Nova Scotia, Canada, NS B3K 6R8
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age > 7 years and < 20 years.
- Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
- Judged to be in good health on the basis of reported medical history.
- Available for planned length of the study.
- Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.
A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Exclusion Criteria:
- Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
- Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
- Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
- Receipt of TD/Td within the preceding 12 months.
- Known or suspected to be pregnant.
A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1
18 to 30 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andre navne:
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2
30 to 42 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andre navne:
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|
3
42 to 54 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andre navne:
|
|
4
54 to 66 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andre navne:
|
|
5
66 to 78 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andre navne:
|
|
6
78 to 90 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andre navne:
|
|
7
90 to 102 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andre navne:
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8
102 to 114 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andre navne:
|
|
9
Control - over 114 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To provide safety information on ADACEL® vaccine given at different time intervals.
Tidsramme: Up to 114 months post-vaccination
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Up to 114 months post-vaccination
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TD511
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 .
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