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| Name | Class |
|---|---|
| Government-wide R&D Fund project for infectious disease research (GFID) | UNKNOWN |
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This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women vaccinated with a QIV | 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. |
| |
| Pregnant women unvaccinated with a QIV | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza vaccine | Biological | quadrivalent influenza vaccination in the flu seasons |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of adverse pregnancy outcomes | 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. | from delivery up to 1 year after birth |
| Risk of vaccine-related adverse events | Vaccine-related adverse events confirmed by diagnostic records in the NHIS database. | from delivery up to 1 year after birth |
| Risk of poor health outcomes in pregnant women | 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. | from delivery up to 1 year after birth |
| Risk of poor health outcomes in neonates | 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. | from delivery up to 1 year after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of pregnancy-related complications | Pre-eclampsia/eclampsia, gestational diabetes mellitus, antenatal bleeding, postpartum hemorrhage, and maternal death, which are confirmed by diagnostic records in the NHIS database. | from delivery up to 1 year after birth |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women during the period of the national immunization program in South Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunha Noh, PharmD | Contact | +82-31-299-4377 | noh.yh@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ju-Young Shin, PhD | Sungkyunkwan University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26238723 | Background | Baum U, Leino T, Gissler M, Kilpi T, Jokinen J. Perinatal survival and health after maternal influenza A(H1N1)pdm09 vaccination: A cohort study of pregnancies stratified by trimester of vaccination. Vaccine. 2015 Sep 11;33(38):4850-7. doi: 10.1016/j.vaccine.2015.07.061. Epub 2015 Aug 1. | |
| 32972737 | Background |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Macias Saint-Gerons D, Sola Arnau I, De Mucio B, Arevalo-Rodriguez I, Aleman A, Castro JL, Ropero Alvarez AM. Adverse events associated with the use of recommended vaccines during pregnancy: An overview of systematic reviews. Vaccine. 2021 Jul 30;39 Suppl 2:B12-B26. doi: 10.1016/j.vaccine.2020.07.048. Epub 2020 Sep 21. |
| 31292120 | Background | Walsh LK, Donelle J, Dodds L, Hawken S, Wilson K, Benchimol EI, Chakraborty P, Guttmann A, Kwong JC, MacDonald NE, Ortiz JR, Sprague AE, Top KA, Walker MC, Wen SW, Fell DB. Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study. BMJ. 2019 Jul 10;366:l4151. doi: 10.1136/bmj.l4151. |
| 26572546 | Background | Ludvigsson JF, Strom P, Lundholm C, Cnattingius S, Ekbom A, Ortqvist A, Feltelius N, Granath F, Stephansson O. Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design. BMJ. 2015 Nov 16;351:h5585. doi: 10.1136/bmj.h5585. |
| 27893898 | Background | Hviid A, Svanstrom H, Molgaard-Nielsen D, Lambach P. Association Between Pandemic Influenza A(H1N1) Vaccination in Pregnancy and Early Childhood Morbidity in Offspring. JAMA Pediatr. 2017 Mar 1;171(3):239-248. doi: 10.1001/jamapediatrics.2016.4023. |