Pregnancy RelatedNCT04579822
Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
An observational study of Pregnancy Related and Influenza Virus Vaccine Adverse Reaction, run by Sungkyunkwan University.
Trial summary
This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Influenza Virus Vaccine Adverse Reaction
- What is being tested?
- influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 300,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women during the period of the national immunization program in South Korea.
Who may be able to join
- Pregnant women between September 22, 2020, and April 30, 2021.
Who cannot join
- Women aged <20 or >45 years
- Pregnancies with a chromosomal abnormality
- Pregnancies with exposure to a known teratogenic medication
Trial locations and contacts
No sites are listed yet.
About this study
This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.
Read the 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).
- Being tested
- influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccineBiological
quadrivalent influenza vaccination in the flu seasons
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from delivery up to 1 year after birth
Secondary outcomes (1)
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.
Measured: from delivery up to 1 year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sungkyunkwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Government-wide R&D Fund project for infectious disease research (GFID)
- Responsible party
- Principal investigator, Ju-Young Shin, Sungkyunkwan University
- Investigators
- Ju-Young Shin, PhD, Principal investigator, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579822
- Sponsor's protocol ID
- SKKU-2020-FP
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26238723Macias 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.
PubMed 32972737Walsh 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.
PubMed 31292120Ludvigsson 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.
PubMed 26572546Hviid 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.
PubMed 27893898
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
- ClinicalTrials.gov ID
- NCT04579822
- Acronym / sponsor ID
- SKKU-2020-FP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Sungkyunkwan UniversityUniversity, hospital or other
- Collaborators
- Government-wide R&D Fund project for infectious disease research (GFID)
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women vaccinated with a QIV | – | Biological: influenza vaccineWomen 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. |
| Pregnant women unvaccinated with a QIV | – | Biological: influenza vaccineWomen 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. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women during the period of the national immunization program in South Korea.
Key inclusion criteria (1 listed)
- Pregnant women between September 22, 2020, and April 30, 2021.
Key exclusion criteria (3 listed)
- Women aged <20 or >45 years
- Pregnancies with a chromosomal abnormality
- Pregnancies with exposure to a known teratogenic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza vaccinequadrivalent influenza vaccination in the flu seasons | Biological | Pregnant women unvaccinated with a QIV, Pregnant women vaccinated with a QIV |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Risk of pregnancy-related complications
Time frame: from delivery up to 1 year after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 26238723Baum 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.
- Background: PubMed 32972737Macias 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.
- Background: PubMed 31292120Walsh 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.
- Background: PubMed 26572546Ludvigsson 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.
- Background: PubMed 27893898Hviid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Young Shin, PhD principal investigator
Sungkyunkwan University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Influenza Virus Vaccine Adverse Reaction, run by Sungkyunkwan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunha Noh, PharmD (+82-31-299-4377, noh.yh@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of adverse pregnancy outcomes (time frame: from delivery up to 1 year after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579822, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.