Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.
Healthy Japanese Male Adults
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults|
- The number of subjects within each treatment arm who experienced influenza-like symptoms [ Time Frame: Within 6 days post vaccination ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Adverse events were classified according to the "Glossary of Side Effects of Pharmaceutical Agents, 1996."
|Study Start Date:||August 2002|
|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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224783
|Study Director:||Robert Walker, MD||MedImmune LLC|