An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children
Phase of Trial: Phase III
Latest Information Update: 12 Jan 2018
At a glance
- Drugs GSK 2321138A (Primary) ; Hepatitis A vaccine inactivated; Pneumococcal 7-valent CRM197 vaccine conjugate; Varicella zoster virus vaccine live
- Indications Chickenpox; Hepatitis A; Hepatitis B; Influenza virus infections; Pneumococcal infections
- Focus Registrational; Therapeutic Use
- Sponsors GlaxoSmithKline
- 12 Jan 2018 GSK has received approval from the US Food and Drug Administrations (FDA) Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older, based on the data from this trial and on two supportive studies, as reported in a media release.
- 15 Mar 2017 According to a GlaxoSmithKline media release, data from this study will be presented at upcomming annual meeting of European Society for Paediatric Infectious Diseases.
- 15 Mar 2017 According to a GlaxoSmithKline media release, company submitted a supplemental Biologics License Application (sBLA) to the US FDA to seek an expanded indication for the quadrivalent influenza vaccine for children six months through 35 months of age, based on data from this and other two two supportive studies.