Reactogenicity of two 2010 trivalent inactivated influenza vaccine formulations in adults

Abstract

Objective: To assess the reactogenicity of two 2010 trivalent inactivated influenza vaccine (TIV) formulations among adults, including the formulation associated with febrile convulsions among children in Australia.

Design, setting and participants: We retrospectively interviewed persons aged ≥18 years who received TIV between 11 March and 24 April 2010 at a large general practice in Perth. All 160 persons who received Influvac® (Solvay) and a random sample of 190 of 451 persons who received Fluvax® (CSL Biotherapies) were included in the assessment; 127 (79%) recipients of Influvac® and 156 (82%) of the Fluvax® recipients completed the interview.

Main outcome measures: Patient demographics, the presence of underlying medical conditions, prior influenza vaccination history, self-reported onset of local and/or systemic symptoms within 72 h following receipt of 2010 TIV, and use of anti-fever/pain medication following TIV vaccination were examined.

Results: The mean age of the vaccinees was 54 years for both the Fluvax® and Influvac® brand cohorts and there was no significant difference between the cohorts with regard to gender or the presence of underlying medical conditions. In bivariate analyses, reported swelling (18% vs 7%, p=0.009), muscle pain (12% vs 3%, p=0.014) and use of anti-fever/pain medication after TIV vaccination (12% vs 2%, p=0.008) were each significantly more common for patients who received Fluvax® compared to those who received Influvac®. In multivariate analyses simultaneously controlling for age, gender, receipt of seasonal influenza vaccine prior to 2010 and receipt of 2009 H1N1 pandemic vaccine, vaccination with Fluvax® TIV was a significant independent predictor of muscle pain and/or swelling (OR=3.3, 95% CI 1.5-7.4 p=0.004). No significant differences in the proportion of patients reporting systemic reactions were observed.

Conclusions: In this setting, 2010 Fluvax® was associated with a greater likelihood of local reactions among adults, compared to 2010 Influvac® TIV.