Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
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|ClinicalTrials.gov Identifier: NCT00224783|
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : January 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Japanese Male Adults||Biological: CAIV-T Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults|
|Study Start Date :||August 2002|
|Actual Study Completion Date :||September 2002|
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.
Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)
Other Name: 0.2 mL, by nebulizer
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.
0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
- The number of subjects within each treatment arm who experienced influenza-like symptoms [ Time Frame: Within 6 days post vaccination ]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.
- The number of subjects within each treatment arm who experienced adverse events [ Time Frame: Within 28 days of vaccination ]Adverse events were classified according to the "Glossary of Side Effects of Pharmaceutical Agents, 1996."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224783
|Study Director:||Robert Walker, MD||MedImmune LLC|