Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

PHASE4CompletedINTERVENTIONAL
Enrollment

1,060

Participants

Timeline

Start Date

October 5, 2018

Primary Completion Date

January 4, 2019

Study Completion Date

January 4, 2019

Conditions
Influenza, Human
Interventions
OTHER

Passive enhanced safety surveillance

Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged \<9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).

Trial Locations (9)

1820

GSK Investigational Site, Steenokkerzeel

3000

GSK Investigational Site, Leuven

3980

GSK Investigational Site, Tessenderlo

29603

GSK Investigational Site, Marbella - Málaga

41014

GSK Investigational Site, Seville

80339

GSK Investigational Site, Munich

85221

GSK Investigational Site, Dachau

94550

GSK Investigational Site, Künzing

08035

GSK Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03688620 - Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season | Biotech Hunter | Biotech Hunter