Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

NCT04579822 | Unknown

• 1 other identifier: SKKU-2020-FP
• Study Type: observational
• Target: 300,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pregnancy Related; Influenza Virus Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Risk of pregnancy-related complications

  from delivery up to 1 year after birth

Study Arms (2)

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.

Biological: influenza vaccine

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.

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

quadrivalent influenza vaccination in the flu seasons

Pregnant women unvaccinated with a QIV; Pregnant women vaccinated with a QIV

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women during the period of the national immunization program in South Korea.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sungkyunkwan University: lead
• Government-wide R&D Fund project for infectious disease research (GFID): collaborator

Related 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.

  PMID: 26238723 BACKGROUND

• 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.

  PMID: 32972737 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.

  PMID: 31292120 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.

  PMID: 26572546 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.

  PMID: 27893898 BACKGROUND

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ju-Young Shin, PhD

  Sungkyunkwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunha Noh, PharmD

CONTACT

+82-31-299-4377; noh.yh@skku.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share