Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults

NCT00224783

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Japanese Male Adults
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Healthy Japanese Male AdultsPhase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
NCT00224783
Male
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Biological: CAIV-T
    Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)
    Other Name: 0.2 mL, by nebulizer
  • Biological: Placebo
    0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
Study Arms  ICMJE
  • Active Comparator: CAIV-T
    CAIV-T contains 3 cold-adapted influenza virus strains (A/H1N1, A/H3N2, B) concentrated and refined by centrifugal separation from the chorioallantoic membrane of specific pathogen-free (SPF) eggs, containing SPG (sucrose-phosphate-glutamate), arginine, and acid hydrolyzed pig gelatin as stabilizers. Subjects were inoculated once with about 0.1 mL of investigational vaccine in each nasal cavity (a total of 0.2 mL) using a nebulizer.
    Intervention: Biological: CAIV-T
  • Placebo Comparator: Placebo
    Placebo contained 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2). Subjects received about 0.1 mL (a total 0.2 mL) of the control drug using a nebulizer.
    Intervention: Biological: Placebo
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
 (submitted: September 20, 2005)
45
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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
Study Director:Robert Walker, MDMedImmune LLC
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