NCT00192413View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,009

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

November 30, 2002

Study Completion Date

November 30, 2002

Conditions
Influenza
Interventions
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).

Trial Locations (4)

Unknown

Docnor House, Durban North

Hazelmed Family Practice, Hazelwood

Jansen van Rensburg, eManzimtoti

Christiaan Tertius de Villiers, Scottburgh South

Sponsors

Lead Sponsor

MedImmune LLC
All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

MedImmune LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter