NCT00283283

Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine

Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,316 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.

Detailed description

This was a Phase II prospective, single-blind to dose, randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®, 2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines, were divided into 8 strata based on age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose (0.25mL) Fluzone® or full-dose (0.5mL) Fluzone® by intramuscular injection into the deltoid muscle.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® (Aventis Pasteur inactivated influenza vaccine)	A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2006-05-01
• First posted: 2006-01-27
• Last updated: 2021-02-12
• Results posted: 2020-06-19

Locations

2 sites across 1 country: United States