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- Klinische proef NCT00524732
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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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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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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1
18 to 30 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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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
Andere namen:
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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
Andere namen:
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4
54 to 66 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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5
66 to 78 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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6
78 to 90 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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7
90 to 102 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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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
Andere namen:
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9
Control - over 114 months since last prior dose of TD/Td vaccine.
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0.5 mL, Intramuscular
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To provide safety information on ADACEL® vaccine given at different time intervals.
Tijdsspanne: Up to 114 months post-vaccination
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Up to 114 months 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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TD511
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