Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Japanese Male Adults

Outcome Measures

Primary Outcomes (1)

The number of subjects within each treatment arm who experienced influenza-like symptoms
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature \> or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.
Within 6 days post vaccination

Secondary Outcomes (1)

The number of subjects within each treatment arm who experienced adverse events
Within 28 days of vaccination

Study Arms (2)

CAIV-T

ACTIVE COMPARATOR

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.

Biological: CAIV-T

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

CAIV-TBiological

Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)

Also known as: 0.2 mL, by nebulizer

CAIV-T

PlaceboBiological

0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).

Eligibility Criteria

Age20 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Industrycollaborator
MedImmune LLC
Industrylead

MeSH Terms

Interventions

FluMist

Study Officials

Robert Walker, MD
MedImmune LLC
STUDY DIRECTOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 23, 2005

Study Start

August 2002

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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).

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

CAIV-T

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

CAIV-T

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record