ArticleInfluenza and other respiratory viruses2022
Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry.
Article in Influenza and other respiratory viruses, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01945424 (Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol
Who cites it
6 citing papers in PubMed, 10 citations in OpenAlex.
- Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence.Frontiers in drug safety and regulation · 2025Article
- Summary of the National Advisory Committee on Immunization (NACI) Updated Guidance on Influenza Vaccination During Pregnancy.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2024Article
- Assessing the Presence of IgG Antibodies against Influenza Viruses in Neonates after Maternal Vaccination and Factors That May Affect the Transplacental Transfer.Diseases (Basel, Switzerland) · 2023Article
- Maternal vaccination-current status, challenges, and opportunities.The journal of obstetrics and gynaecology research · 2023Review
- Article
- Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry.Influenza and other respiratory viruses · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Fluzone® Quadrivalent (IIV4, Sanofi Pasteur) Pregnancy Registry was created to monitor vaccine safety during pregnancy (clinicaltrials.gov, NCT01945424). Here, we describe maternal, pregnancy, obstetrical and neonatal outcomes after vaccine exposure in pregnant women between August 2013 and September 2019.
methodsAll women exposed to IIV4 during their pregnancy were eligible for inclusion. Outcomes were prospective (reported following vaccine exposure but before knowledge of pregnancy outcome ascertained through prenatal tests) or retrospective (prenatal tests were undertaken before the exposure was reported).
resultsAmong 239 IIV4 vaccine exposure reports received, there were 105 prospective and 10 retrospective reports of maternal adverse events (AEs). The most frequent prospectively reported maternal AEs were medication errors (expired product [n = 8, 3.8%]; extra dose [n = 7, 3.3%]) and injection site pain (n = 7, 3.3%). Among 62 prospectively reported pregnancy and obstetrical events with available follow-up information, seven AEs were reported, four (6.4%) of which were spontaneous abortions. A further seven AEs were reported among the 29 retrospective pregnancy and obstetrical events with available follow-up information. Among neonatal outcomes (15 prospective; 28 retrospective), >85% were reported as full-term births. One premature birth was reported prospectively. Four other neonatal AEs were reported, all retrospectively: two cases of talipes (club foot), one central nervous system anomaly and one atrial septal defect. All infants with available information had normal APGAR scores at 5 minutes.
conclusionsThe frequency of AEs following exposure to IIV4 during pregnancy did not indicate new safety concerns.
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