Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

Pregnancy Related Clinical Trial

Official title:

Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04579822
• Other study ID #: SKKU-2020-FP
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: Sungkyunkwan University
• Contact: Yunha Noh, PharmD
• Phone: +82-31-299-4377
• Email: noh.yh[@]skku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300000
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza Virus Vaccine Adverse Reaction
• Influenza, Human
• Pregnancy Related

Intervention

Biological:
• influenza vaccine
quadrivalent influenza vaccination in the flu seasons

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sungkyunkwan University	Government-wide R&D Fund project for infectious disease research (GFID)

References & Publications (5)

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. — View Citation

Hviid A, Svanström H, Mølgaard-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. — View Citation

Ludvigsson JF, Ström P, Lundholm C, Cnattingius S, Ekbom A, Örtqvist Å, 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. — View Citation

Macias Saint-Gerons D, Solà Arnau I, De Mucio B, Arévalo-Rodríguez I, Alemán A, Castro JL, Ropero Álvarez AM. Adverse events associated with the use of recommended vaccines during pregnancy: An overview of systematic reviews. Vaccine. 2020 Sep 21. pii: S0264-410X(20)30979-8. doi: 10.1016/j.vaccine.2020.07.048. [Epub ahead of print] Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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