Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza (Healthy Volunteers)
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 1804
- Locations
- 15
- Primary Endpoint
- Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22.
The secondary objectives of the study are:
- To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.
- To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.
- To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.
Detailed Description
Study duration per participant is maximum 2 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
Time Frame: Within 7 days after vaccination
The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards
ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
Time Frame: Within 7 days after vaccination
The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards
Secondary Outcomes
- Vaccinees' reporting rate according to age group(Within 7 days after vaccination)
- ADR reporting rate according to age group(Within 7 days after vaccination)
- Serious suspected ADR reporting rate at any time following vaccination within the EPSS period(From vaccination to end of data collection (maximum 2 months following first vaccination))
- Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period(From vaccination to end of data collection (maximum 2 months following first vaccination))