Vaccine Adverse ReactionNCT06180447
Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
An observational study of Vaccine Adverse Reaction, run by Sun Xin at 1 site in China.
Trial summary
Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight) Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Vaccine Adverse Reaction
- What is being tested?
- Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 150,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Mar 2025
- 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 14 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.
Who may be able to join
- All pregnant women in Xiamen who registry in our database.
Who cannot join
- Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.
Trial locations and contacts
1 site in 1 country.
China1 site
The West China Hospital of Sichuan university
Chengdu, Sichuan, 610041
About this study
Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)
Read the detailed description
We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.
The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.
- Conditions
- Vaccine Adverse Reaction
- Being tested
- Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine
- Keywords
- Vaccine, birth defect, adverse pregnancy outcomes
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccineBiological
Exposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth defects
BDs were defined as any prenatal malformation (including structural, functional, or metabolic disorders) diagnosed through systematic ultrasound or genetic testing during pregnancy and any malformation diagnosed by clinicians within 42 days of birth，which were coded according to the International Classification of Diseases, Tenth Revision (ICD-10) (Q00-Q99).
Measured: From pregnancy to 42 days after delivery
Secondary outcomes (1)
Incidence of Adverse pregnancy outcomes
Including gestational diabetes, fetal distress, premature rupture of membranes, low birth weight and so on.
Measured: From pregnancy to 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine Adverse ReactionStudies 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
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Xin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, PhD, Study chair, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180447
- Sponsor's protocol ID
- Vaccine registry study
- Status last verified
- May 2024
- First submitted
- 12 Dec 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets are not publicly available, but are available from the corresponding author on reasonable request.
Publications
Guo J, Zhao P, Liu C, Liao M, Chen J, Ren Y, Yao G, Qian Y, Rong B, Qi H, Chen M, Zou K, Xiong Y, Sun X, Tan J. Peri-Conception Human Papillomavirus Vaccination Exposure and Risk of Birth Defects: A Population-Based Retrospective Cohort Study. Pharmacoepidemiol Drug Saf. 2025 Oct;34(10):e70222. doi: 10.1002/pds.70222.
PubMed 40984047
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06180447
- Acronym / sponsor ID
- Vaccine registry study
- Conditions
- Vaccine Adverse Reaction
- Keywords
- Vaccine, birth defect, adverse pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Sun XinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 22 Dec 2023 (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.
Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)
Detailed description
We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.
The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.
Key inclusion criteria (1 listed)
- All pregnant women in Xiamen who registry in our database.
Key exclusion criteria (1 listed)
- Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.
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 |
|---|---|---|
| Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccineExposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy. | Biological | – |
Primary outcome
Birth defects
Time frame: From pregnancy to 42 days after delivery
BDs were defined as any prenatal malformation (including structural, functional, or metabolic disorders) diagnosed through systematic ultrasound or genetic testing during pregnancy and any malformation diagnosed by clinicians within 42 days of birth，which were coded according to the International Classification of Diseases, Tenth Revision (ICD-10) (Q00-Q99).
1 secondary outcome
Incidence of Adverse pregnancy outcomes
Time frame: From pregnancy to 42 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 40984047Guo J, Zhao P, Liu C, Liao M, Chen J, Ren Y, Yao G, Qian Y, Rong B, Qi H, Chen M, Zou K, Xiong Y, Sun X, Tan J. Peri-Conception Human Papillomavirus Vaccination Exposure and Risk of Birth Defects: A Population-Based Retrospective Cohort Study. Pharmacoepidemiol Drug Saf. 2025 Oct;34(10):e70222. doi: 10.1002/pds.70222.
- Individual participant dataSharing planned: No. The datasets are not publicly available, but are available from the corresponding author on reasonable request.
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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.
Xin Sun, PhD study chair
Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Adverse Reaction, run by Sun Xin at 1 site in China.
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 1 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth defects (time frame: From pregnancy to 42 days after delivery). 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 NCT06180447, which also lists 1 linked publication.
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 7 May 2024.