Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
NCT00224783
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Age of 20 years old or over but below 45 years old (at the time of consent)
- Persons judged suitable by the principal investigator or investigator from the results of prior history, physical examination and clinical findings.
- Persons having the ability to understand consent and a written consent obtained prior to the start of screening.
- Persons being able to participate in the trial for 1 month from the inoculation of the trial vaccine to the completion of the trial.
- Persons being able to be contacted (by phone, hospital visit or house visit) by the trial staff at the time of testing after 28 days from the inoculation of the trial vaccine.
- Persons judged to be impossible or difficult to contact for requesting hospital visits
to carry out clinical evaluation and tests during the trial term.
- Persons having a prior history of or suspected immunological disease, or those
receiving administration of systemic corticosteroids or immunosuppressants such as
cytotoxic drugs (e.g., methotrexate, etc.)
- Persons having blood formulations such as immunoglobulin, etc., administered or
planned during a period from one month before the inoculation of the trial vaccine to
the completion of the trial.
- Persons living with any person with a nonfunctional or suppressed immune system (by
using immunosuppressants, etc.), in the same household.
- Persons with a prior history of hypersensitivity to chicken eggs or chicken egg
proteins or components of the trial vaccine (such as sucrose, phosphoric acid,
glutamate, arginine and acid-hydrolyzed pig gelatin).
- Persons inoculated with a live virus vaccine within 1 month before screening.
- Persons having the planned administration of another trial vaccine or drug during the
period from one month before screening to the completion of the trial
- Person having an influenza treatment drug (such as commercially available drugs or
trial vaccines: for example, Oseltamivir, Zanamivir, Amantadine, etc.), administered
within one month before screening. Incidentally, no prophylactic administration of an
influenza viral drug was permitted.
- Persons inoculated with an influenza vaccine within 6 months before screening or
planned to be inoculated with an influenza vaccine during the term of the present
trial.
- Persons with blood drawn quantity (including blood donation) of 400 mL or more within
3 months or 200 mL or more within 1 month before screening.
- Persons with a history of any febrile disorders (oral cavity temperature ³ 38.0°C) or
other acute disorders within 36 hours before trial vaccine inoculation.
- Persons who had upper respiratory tract disorders themselves or whose family members
had such disorders within 72 hours before trial vaccine inoculation.
- Persons treated with an antibiotic within 72 hours before trial vaccine inoculation.
- Persons with an acute asthmatic symptom.
- Persons judged to have a pathology preventing the evaluation of the trial effect by
the principal investigator (or investigator).
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Descriptive Information | ||||
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Brief Title ICMJE | Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults | |||
Official Title ICMJE | Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults | |||
Brief Summary | The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults. | |||
Detailed Description | The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention | |||
Condition ICMJE | Healthy Japanese Male Adults | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 45 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2002 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00224783 | |||
Other Study ID Numbers ICMJE | D153 P800 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Christopher Ambrose, MD, Medimmune, LLC | |||
Study Sponsor ICMJE | MedImmune LLC | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | MedImmune LLC | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |