Journal Article

Clinical Efficacy of Cell Culture—Derived and Egg-Derived Inactivated Subunit Influenza Vaccines in Healthy Adults

Sharon Frey, Timo Vesikari, Agnieszka Szymczakiewicz-Multanowska, Maria Lattanzi, Allen Izu, Nicola Groth and Sandra Holmes

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue 9, pages 997-1004
Published in print November 2010 | ISSN: 1058-4838
Published online November 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/656578
Clinical Efficacy of Cell Culture—Derived and Egg-Derived Inactivated Subunit Influenza Vaccines in Healthy Adults

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

Background. More efficient methods are needed to manufacture influenza vaccines. This trial compared the efficacy of cell culture-derived influenza vaccine (CCIV) and egg-derived trivalent inactivated vaccine (TIV) with placebo against laboratory-confirmed influenza illness in healthy adults in the United States, Finland, and Poland during the 2007-2008 influenza season.

Methods. A total of 11,404 study participants aged 18-49 years were randomized equally to receive CCIV (Optaflu; n = 3828), TIV (Agrippal; n = 3676), or placebo (n = 3900). Each participant was observed during a 6-month study surveillance period. Nasal and throat swabs for virus isolation and characterization were collected from all patients with influenza-like illness. Vaccine immunogenicity was evaluated in a subset of 1045 participants.

Results. Efficacy of CCIV and TIV against vaccine-like (83.8% [1-sided 97.5% confidence interval [CI] lower limit, 61.0%] and 78.4% [1-sided 97.5% CI lower limit, 52.1%], respectively) and all circulating influenza virus strains (69.5% [1-sided 97.5% CI lower limit, 55.0%] and 63.0% [1-sided 97.5% lower limit, 46.7%], respectively) exceeded the Center for Biologics Evaluation and Research efficacy criteria. Immunogenicity of both vaccines exceeded the Center for Biologics Evaluation and Research licensing criteria. Both vaccines were well tolerated, with similar safety profiles. Most solicited reactions were mild to moderate in severity and transient. No vaccination-related serious adverse events were reported; no withdrawals resulted from vaccine-related adverse events.

Conclusions. Both CCIV and TIV were effective in preventing influenza caused by vaccine-like and by all circulating influenza virus strains, were well tolerated, and had good safety profiles. Both vaccines can be considered for annual influenza vaccination campaigns.

Clinical trials registration. NCT00630331.

Journal Article.  4155 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.