Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons

Abstract

Background

Adult and elderly subjects previously immunized with cell culture-derived (CCIV; Optaflu^®) or egg-derived (TIV; Agrippal^®) trivalent influenza vaccines were enrolled in two extension studies (E1 and E2) to evaluate safety and immunogenicity after revaccination with CCIV/TIV alone or in combination with concomitant pneumococcal vaccine (PV).

Methods

Adults and elderly subjects (n = 2609) were randomized 1:1 in E1 and allocated 3:1 in E2 to receive CCIV/TIV. In E2, a subset of elderly subjects was randomized to receive CCIV/TIV, with or without PV. Adverse reactions were monitored for six months and immunogenicity was assessed by hemagglutination inhibition (HI) assay using CHMP criteria.

Results

Overall, the safety profile of both vaccines was similar, no serious adverse events related to either vaccine occurred. Mild or moderate pain was the most commonly reported reaction. Reactogenicity was slightly higher in elderly subjects receiving CCIV/TIV concomitantly with PV [46% vs. 37%; p = non-significant (NS)]. Both vaccines met CHMP licensure criteria for adults and elderly subjects. With concomitant CCIV and PV, all three CHMP criteria were met for A/H1N1 and A/H3N2, whereas the B strain only met seroprotection and GMR criteria.

Conclusions

Safety and immunogenicity of CCIV was not influenced by the type of vaccine received previously or by concomitant PV administration.

Keywords: :

• Cell culture-derived vaccine
• adults
• concomitant vaccines
• elderly
• immunogenicity
• influenza vaccine
• pneumococcal vaccine
• safety

Acknowledgments

The authors would like to thank the study investigators Dr. Ryszard Konior, Dr. Jolanta Guzik, Dr. Maria Świeboda and Dr. Marian Patrzałek. Editorial assistance was provided by Dr Jamie Stirling and Dr.Pinki Rajeev, Novartis Vaccines and Diagnostics. Responsibility for opinions, conclusions, and interpretation of data lies with the authors.

Trial registration number

NCT00306527 (E1); NCT00579345 (E2)

Funding

Both studies were sponsored by Novartis Vaccines and Diagnostics.

Financial disclosure and conflict of interest

Agnieszka Szymczakiewicz-Multanowska has received research funding from Novartis Vaccines and was working at Monipol at the time of the study; Maria Lattanzi, Allen Izu, MariaVittoria Sparacio, Csaba Kovacs, and Nicola Groth are employees of Novartis Vaccines and Diagnostics. Daniela Casula was an employee of Novartis Vaccines and Diagnostics at the time of the study.

Previous presentation

Long-term safety of a cell-derived influenza subunit vaccine after revaccination in healthy adult and elderly subjects. A Multanowska, M Lattanzi. Influenza Vaccines for the World, Cannes, France, 27–30 April 2009.