- Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccinesFernanda Tavares Da Silva
GlaxoSmithKline Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium
Vaccine 31:1870-6. 2013..To date there are no guidelines for collection, documentation and monitoring of potential immune mediated disorders (pIMD) reported in the course of clinical trials with adjuvanted vaccines...
- Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccineFernanda Tavares
GlaxoSmithKline Vaccines, Wavre, Belgium
Vaccine 31:1759-64. 2013..In conclusion there is no statistical evidence that the investigational HSV vaccine increased the risk of spontaneous or elective abortion...
- Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: a prospective cohort studyFernanda Tavares
Global Vaccine Development, GlaxoSmithKline GSK Biologicals, Parc de la Noire Epine, Avenue Fleming 20, 1300 Wavre, Belgium
Vaccine 29:6358-65. 2011....
- The safety evaluation of adjuvants during vaccine development: the AS04 experienceNathalie Garçon
GlaxoSmithKline Biologicals, Avenue Fleming, 20, 1300 Wavre, Belgium
Vaccine 29:4453-9. 2011..We also discuss how the knowledge of adjuvant mode of action can support the current practice of safety evaluation...
- Anaphylaxis following H1N1 pandemic vaccines: safety data in perspectiveFernanda Tavares
GlaxoSmithKline Biologicals, Wavre, Belgium
Vaccine 29:6402-7. 2011..Our analysis also highlighted the challenges of reliably determining the rate of anaphylaxis as an adverse event in the postmarketing setting following mass vaccination, as anaphylaxis was excluded in 45.8% of reported cases...