NCT00192270

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children

A Prospective, Open-label, Phase II, Multi-center Study of the Safety, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children, Aged 6 to 17 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 498 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.

Detailed description

This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age. Subjects were allocated to one of three study groups according to age at the time of enrollment: study group one consisted of subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group three of subjects 13 to 17 years of age. Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an open-label manner.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CAIV-T	Each dose of the vaccine was formulated to contain approximately 1 x 10\^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of \~3 x 10\^7 TCID50 per dose.

Timeline

• Start date: 2000-10-01
• Primary completion: 2001-01-01
• Completion: 2001-01-01
• First posted: 2005-09-19
• Last updated: 2012-03-06

Locations

3 sites across 2 countries: Belgium, Finland