Influenza Virus Vaccine Adverse Reaction, Pregnancy Related
Conditions
Brief 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).
Interventions
BIOLOGICALinfluenza vaccine
quadrivalent influenza vaccination in the flu seasons
Sponsors
Government-wide R&D Fund project for infectious disease research (GFID)
Sungkyunkwan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of adverse pregnancy outcomes | from delivery up to 1 year after birth | Spontaneous abortion, stillbirth, neonatal death, congenital anomaly, pre-term birth, fetal growth restriction, small for gestational age, and low birth weight, which are confirmed by diagnostic records in the NHIS database. |
| Risk of vaccine-related adverse events | from delivery up to 1 year after birth | Vaccine-related adverse events confirmed by diagnostic records in the NHIS database. |
| Risk of poor health outcomes in pregnant women | from delivery up to 1 year after birth | Hospital admission, emergency department visits, influenza infection, and hospitalization with influenza infection, which are confirmed by diagnosis and healthcare utilization records in the NHIS database. |
| Risk of poor health outcomes in neonates | from delivery up to 1 year after birth | Respiratory distress, neonatal intensive care unit admission, and hospital visits with neonatal infection or fever, which are confirmed by diagnosis and healthcare utilization records in the NHIS database. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of pregnancy-related complications | from delivery up to 1 year after birth | Pre-eclampsia/eclampsia, gestational diabetes mellitus, antenatal bleeding, postpartum hemorrhage, and maternal death, which are confirmed by diagnostic records in the NHIS database. |
Contacts
Primary ContactYunha Noh, PharmD
Outcome results
None listed