Post-authorisation Passive Enhanced Safety Surveillance of Seasonal

Clinical Trial Summary

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.

See also
Status	Clinical Trial	Phase
Completed	`NCT03275389` - A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years	Phase 1
Completed	`NCT03442582` - Afluria Pregnancy Registry
Completed	`NCT05981846` - A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19	Phase 2
Completed	`NCT05044195` - A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age	Phase 3
Completed	`NCT02914275` - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.	Phase 3
Completed	`NCT04590066` - Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy	N/A
Recruiting	`NCT03778203` - Development of Childhood Anti-influenza Immunity	Phase 4
Completed	`NCT04527614` - Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection	N/A
Terminated	`NCT03658629` - Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults	Phase 2
Completed	`NCT05269290` - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections	Phase 3
Completed	`NCT06385821` - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus	Phase 3
Completed	`NCT02867358` - A Clinical Trial of KT07 Capsule in the U.S.A	Phase 2
Completed	`NCT02998996` - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU	Phase 1/Phase 2
Completed	`NCT02984280` - Specific Respiratory Infections as Triggers of Acute Medical Events	N/A
Withdrawn	`NCT02883972` - Childhood Influenza Immunisation Invitation Trial in Schools	N/A
Completed	`NCT02545543` - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age	Phase 3
Completed	`NCT02243774` - Mail Outreach To Increase Vaccination Acceptance Through Engagement	N/A
Completed	`NCT02621164` - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents	Phase 3
Completed	`NCT02212106` - A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years	Phase 4
Completed	`NCT02344134` - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects	Phase 3

NCT number	NCT02893878
Study type	Observational
Source	GlaxoSmithKline
Contact
Status	Completed
Phase
Start date	September 12, 2016
Completion date	November 24, 2016

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms