Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
NCT ID: NCT04579822
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300000 participants
OBSERVATIONAL
2020-10-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
influenza vaccine
quadrivalent influenza vaccination in the flu seasons
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.
influenza vaccine
quadrivalent influenza vaccination in the flu seasons
Interventions
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influenza vaccine
quadrivalent influenza vaccination in the flu seasons
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancies with a chromosomal abnormality
* Pregnancies with exposure to a known teratogenic medication
20 Years
44 Years
FEMALE
Yes
Sponsors
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Government-wide R&D Fund project for infectious disease research (GFID)
UNKNOWN
Sungkyunkwan University
OTHER
Responsible Party
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Ju-Young Shin
Associate Professor
Principal Investigators
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Ju-Young Shin, PhD
Role: PRINCIPAL_INVESTIGATOR
Sungkyunkwan University
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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SKKU-2020-FP
Identifier Type: -
Identifier Source: org_study_id
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