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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza, Human

Treatments: Other: Passive enhanced safety surveillance

Study type: Interventional

Funder types: Industry

Identifiers

NCT03688620

207737

Details and patient eligibility

About

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain).

This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

Full description

The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk.

The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards.

Enrollment: 1,060 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the ADR card, return for the next scheduled visit or return the ADR card by mail within a timely manner).
• A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December 2018.
• Subjects aged 6 months or above at the time of the vaccination according to the countries' specificities.
• Written informed consent/informed assent obtained from the subjects/subjects' parent(s)/Legally Acceptable Representative(s) (LARs).

Exclusion criteria

• Child in care.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,060 participants in 3 patient groups

Vaccinated_AlphaRix Tetra Group

Other group

Description:

Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.

Treatment:

Other: Passive enhanced safety surveillance

Vaccinated_Influsplit Tetra Group

Other group

Description:

Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.

Treatment:

Other: Passive enhanced safety surveillance

Vaccinated_Fluarix Tetra Group

Other group

Description:

Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.

Treatment:

Other: Passive enhanced safety surveillance