NCT00192179

A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.

A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.

Detailed description

This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cold-adapted influenza vaccine trivalent (CAIV-T)	The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10\^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10\^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
BIOLOGICAL	Placebo	The placebo consisted of physiologic normal saline.

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2005-09-19
• Last updated: 2012-03-02

Locations

6 sites across 3 countries: Belgium, Poland, United Kingdom