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NCT06180447

Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes

Active, enrolled Last updated 7 May 2024
What this trial tests

trial testing Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine in Vaccine Adverse Reaction in 150,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 January 2024
Primary endpoint
31 December 2024
30 March 2025

Quick facts

Lead sponsorSun Xin
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment150,000
Start date1 January 2024
Primary completion31 December 2024
Estimated completion30 March 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Xin — full company profile →

Who can join

Adults 14 to 65, female only, with Vaccine Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Peri-conception human papillomavirus vaccination exposure and risk of birth defects: a population-based retrospective cohort study
    Guo J, Zhao P, Liu C, Liao M, et al · · 2025 · DOI 10.22541/au.174103926.60657229/v1
  2. Peri-Conception Human Papillomavirus Vaccination Exposure and Risk of Birth Defects: A Population-Based Retrospective Cohort Study.
    Guo J, Zhao P, Liu C, Liao M, et al · · 2025 · PMID 40984047 · DOI 10.1002/pds.70222
  3. Peri-conception human papillomavirus vaccination exposure and risk of birth defects: a population-based retrospective cohort study
    Guo J, Xiong Y, Zhao P, Liu C, et al · · 2024 · DOI 10.21203/rs.3.rs-5294774/v1

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Data sources for this page

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