NCT00192413

Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza

A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,009 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cold-adapted influenza vaccine trivalent (CAIV-T)	Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.
BIOLOGICAL	Trivalent Inactivated Vaccine (TIV)	Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2005-09-19
• Last updated: 2012-03-14

Locations

4 sites across 1 country: South Africa