Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6–35 months

Selection of Adjuvants for Enhanced Vaccine Potency

“…On the other hand, this adjuvant system showed limited effect for a H1N1 -like virus vaccine after administration of two doses in hematopoietic stem cell transplantation recipients [153]. Although the safety profiles of AS03 is acceptable, reactions such as fever tend to increase after a second dose for a H1N1 vaccine in children of 6-35 months [154], and delayed focal lipoatrophy was reported recently after its use in a H1N1 flu vaccine [155]. These vaccine systems are certainly promising but the added complexity of emulsion preparation and difficulty in vaccine characterization are clear disadvantages.…”

Comparison of adverse events following immunization with pandemic influenza A (H1N1)pdm09 vaccine with or without adjuvant among health professionals in Rio de Janeiro, Brazil

“…The studies evaluating the influenza H5N1 vaccine containing the adjuvant AS03 have associated its presence with an increase in vaccine reactogenicity (Leroux-Roels et al 2007, Baras et al 2008, Rümke et al 2008) and trials conducted with the AS03-adjuvanted H1N1 pandemic vaccine also found high rates of adverse events. Local mild to moderate reactions were more common and serious adverse events were rarely reported (Carmona et al 2010, Roman et al 2010a, b, Waddington et al 2010, Nicholson et al 2011.…”

Assessment of squalene adjuvanted and non-adjuvanted vaccines against pandemic H1N1 influenza in children 6 months to 17 years of age

“…The level of dose-sparing achieved in this study with AF03 adjuvanted vaccine appeared similar to that of an AS03 adjuvanted vaccine used in pediatric populations, with an antigen dose as low as 3.75 μg in children from 3 y of age and 1.9 μg in children less than 3 y inducing seroconversion in more than 95% of the children after first vaccination. 24,25 The…”