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Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

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ClinicalTrials.gov Identifier: NCT04579822
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Government-wide R&D Fund project for infectious disease research (GFID)
Information provided by (Responsible Party):
Ju-Young Shin, Sungkyunkwan University

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

Condition or disease Intervention/treatment
Pregnancy Related Influenza Virus Vaccine Adverse Reaction Biological: influenza vaccine

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).
Study Design
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Study Type : Observational
Estimated Enrollment : 300000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.
 Biological: influenza vaccine
quadrivalent influenza vaccination in the flu seasons


Outcome Measures
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Primary Outcome Measures :
  1. Risk of adverse pregnancy outcomes [ Time Frame: from delivery up to 1 year after birth ]
    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.

  2. Risk of vaccine-related adverse events [ Time Frame: from delivery up to 1 year after birth ]
    Vaccine-related adverse events confirmed by diagnostic records in the NHIS database.

  3. Risk of poor health outcomes in pregnant women [ Time Frame: from delivery up to 1 year after birth ]
    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.

  4. Risk of poor health outcomes in neonates [ Time Frame: from delivery up to 1 year after birth ]
    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.


Secondary Outcome Measures :
  1. Risk of pregnancy-related complications [ Time Frame: from delivery up to 1 year after birth ]
    Pre-eclampsia/eclampsia, gestational diabetes mellitus, antenatal bleeding, postpartum hemorrhage, and maternal death, which are confirmed by diagnostic records in the NHIS database.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women during the period of the national immunization program in South Korea.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579822


Contacts
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Contact: Yunha Noh, PharmD +82-31-299-4377 noh.yh@skku.edu

Sponsors and Collaborators
Sungkyunkwan University
Government-wide R&D Fund project for infectious disease research (GFID)
Investigators
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Principal Investigator: Ju-Young Shin, PhD Sungkyunkwan University
More Information
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Publications:

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Responsible Party: Ju-Young Shin, Associate Professor, Sungkyunkwan University
ClinicalTrials.gov Identifier: NCT04579822    
Other Study ID Numbers: SKKU-2020-FP
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases