NCT04579822

Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300,000 (estimated)
• Sponsor: Sungkyunkwan University · Academic / Other
• Sex: Female
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.

Detailed description

The Korean National Immunization Program (NIP) first introduced quadrivalent influenza immunization for all pregnant women in the 2020-2021 season. This nationwide cohort study is proposed to assess the risks of adverse maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control \& Prevention (KCDC).

Conditions

• Pregnancy Related
• Influenza Virus Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	influenza vaccine	quadrivalent influenza vaccination in the flu seasons

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-10-31
• Completion: 2022-12-31
• First posted: 2020-10-08
• Last updated: 2020-10-08