- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00524732
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Charlottetown, Kanada, C1A 7N8
-
-
Nova Scotia
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Halifax, Nova Scotia, Kanada, NS B3K 6R8
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
1
18 to 30 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
2
30 to 42 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
3
42 to 54 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
4
54 to 66 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
5
66 to 78 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
6
78 to 90 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
7
90 to 102 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
8
102 to 114 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
|
9
Control - over 114 months since last prior dose of TD/Td vaccine.
|
0.5 mL, Intramuscular
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To provide safety information on ADACEL® vaccine given at different time intervals.
Tidsram: Up to 114 months post-vaccination
|
Up to 114 months post-vaccination
|
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
Andra studie-ID-nummer
- TD511
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