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. 2020 Oct 1;46(10):324–332. doi: 10.14745/ccdr.v46i10a03

Table 2. Characteristics of IIV3-cc studies included in the systematic review.

Study Design (vaccine) Study population Outcomes
Ambrozaitis et al. (2009) • RCT
• 2005–2006 influenza season
• (IIV3-cc versus egg-based IIV3)
• Healthy adults 18–60 years of age
• IIV3-cc (n=1,028)
• Egg-based IIV3 (n=171)
• AEs within seven days of vaccination
Szymczakiewicz-Multanowska et al. (2009)
NCT00492063
• Phase III, observer blind RCT
• 2004–2005 influenza season
• (IIV3-cc vs egg-based IIV3)
• Healthy adults 18 years of age and older
• IIV3-cc:
    • 18–60 years of age (n=652)
    • 61 years of age and older (n=678)
• Egg-based IIV3:
    • 18–60 years of age (n=648)
    • 61 years of age and older (n=676)
• AEs within seven days of vaccination
Nolan et al.
2016
• Phase III, observer blind RCT
• 2013–2014 influenza season
• (IIV3-cc vs egg-based IIV3)
• Healthy children and adolescents 4–17 years of age
• IIV3-cc (n=1,372)
• Egg-based IIV3 (n=683)
• AEs within seven days of vaccination
Vesikari et al. (2012) • Phase II/III, observer-blind RCT
• October 2007–July 2008
• (IIV3-cc vs egg-based IIV3)
• Healthy children and adolescents 3–17 years of age
• IIV3-cc two doses 3–8 years of age (n=1,599)
• IIV3-cc single dose 9–17 years of age (n=652)
• Egg-based IIV3 3–8 years of age (n=1,013)
• Egg-based IIV3 9–17 years of age (n=316)
• AEs within seven days of vaccination
Frey et al. (2010)
NCT00630331
• Observer-blind RCT
• 2007–2008 influenza season
• (IIV3-cc vs egg-based IIV3)
• Healthy adults 18–49 years of age
• IIV3-cc (n=3,813)
• Egg-based IIV3 (n=3,669)
• Placebo (n=3,894)
• AEs within seven days of vaccination
Loebermann et al. (2019)
NCT01880697
• Phase III open-label, single-arm, study
• 2013–2014 influenza season
• (IIV3-cc)
• Healthy adults
• IIV3-cc:
    • 18–60 years age (n=63)
    • 61 years age and older (n=63)
• AEs following vaccination
Moro et al. (2015) • Clinical review of cases identified through VAERS
• 2013–2014, 2014–2015 influenza seasons
• (IIV3-cc)
• Persons vaccinated with IIV3-cc during July 1, 2013 through March 31, 2015 (reports received by April 30, 2015); excluding non-US reports
• Total reports reviewed: n=629
• Persons vaccinated with IIV3-cc July 1, 2013–March 31, 2015 (reports received by April 30, 2015); excluding non-US reports
• Reports with an AE:
    • n=309
    • during 2013–2014 influenza season (n=389)
    • during 2014–2015 influenza season (n=240)
• AEs following vaccination

Abbreviations: AE, adverse event; IIV3, trivalent inactivated influenza vaccine; IIV3-cc, cell-culture based trivalent inactivated influenza vaccine; NCT, National clinical trial number; RCT, randomized controlled trial; US, United States; VAERS, Vaccine Adverse Event Reporting System