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Clinical Trial
. 2011 Feb;26(2):191-5.
doi: 10.3346/jkms.2011.26.2.191. Epub 2011 Jan 24.

Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country

Joon Young Song  1 , Hee Jin Cheong, Heung Jeong Woo, Seong-Heon Wie, Jin-Soo Lee, Moon-Hyun Chung, Yang Ree Kim, Sook In Jung, Kyung-Hwa Park, Tae Hyong Kim, Soo-Taek Uh, Woo Joo Kim
Affiliations
Clinical Trial

Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country

Joon Young Song et al. J Korean Med Sci. 2011 Feb.

Abstract

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with ≥ 80% of subjects achieving post-vaccination titers ≥ 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.

Keywords: Influenza Vaccines; Influenza, Human; Vaccines, Inactivated.

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Figures

Fig. 1
Fig. 1
Flowchart of subjects through the study.
See this image and copyright information in PMC

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