Clinical trial NCT04579822: Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
Official title: Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Influenza Virus Vaccine Adverse Reaction
Lead sponsor: Sungkyunkwan University
Sponsor class: OTHER
Collaborators: name: Government-wide R&D Fund project for infectious disease research (GFID)
First posted: 2020-10-08
Enrollment: 300000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women during the period of the national immunization program in South Korea.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Risk of adverse pregnancy outcomes
timeFrame: from delivery up to 1 year after birth
measure: Risk of vaccine-related adverse events
timeFrame: from delivery up to 1 year after birth
measure: Risk of poor health outcomes in pregnant women
timeFrame: from delivery up to 1 year after birth
measure: Risk of poor health outcomes in neonates
timeFrame: from delivery up to 1 year after birth
Secondary outcomes:
measure: Risk of pregnancy-related complications
timeFrame: from delivery up to 1 year after birth
Other outcomes:
Locations:
Study officials:
affiliation: Sungkyunkwan University
name: Ju-Young Shin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
citation: 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.
citation: 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.