Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

Sungkyunkwan University

Status: Unknown

Conditions: Pregnancy Related; Influenza Virus Vaccine Adverse Reaction

Treatments: Biological: influenza vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04579822

SKKU-2020-FP

Details and patient eligibility

About

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

Full 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).

Enrollment: 300,000 estimated patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women between September 22, 2020, and April 30, 2021.

Exclusion criteria

• Women aged <20 or >45 years
• Pregnancies with a chromosomal abnormality
• Pregnancies with exposure to a known teratogenic medication

Trial design

300,000 participants in 2 patient groups

Pregnant women vaccinated with a QIV

Description:

Women aged 20-44 years who had received a QIV during their pregnancy between September 22, 2020, and April 30, 2021, under the national immunization program in South Korea.

Treatment:

Biological: influenza vaccine

Pregnant women unvaccinated with a QIV

Description:

Women aged 20-44 years who had not received a QIV during their pregnancy between September 22, 2020, and April 30, 2021, under the national immunization program in South Korea.

Treatment:

Biological: influenza vaccine