SynthesisVaccine2015
Key terms for the assessment of the safety of vaccines in pregnancy: Results of a global consultative process to initiate harmonization of adverse event definitions.
Synthesis in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Barriers and facilitators to vaccination in Latin America: a thematic synthesis of qualitative studies.Cadernos de saude publica · 2024Pooled it
- Guideline
- Efficacy and safety of pertussis vaccination for pregnant women - a systematic review of randomised controlled trials and observational studies.BMC pregnancy and childbirth · 2017Pooled it
- Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.Vaccine · 2016Guideline
- Guideline
- DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2024Trial
- Coadministered Influenza- and Pertussis-Containing Vaccines in Pregnant Women.JAMA network open · 2026Article
- Evaluating the Protective Effects of Influenza Vaccination in Pregnant Women and Their Infants: An Umbrella Review.Iranian journal of public health · 2025Review
- A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus.EClinicalMedicine · 2025Article
- 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
- Infection Leading to Breast Abscess Formation in Pregnancy: A Case Report.International medical case reports journal · 2025Article
- Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review.Vaccine: X · 2024Review
- Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies.Infectious diseases and therapy · 2023Article
- Ensuring the Safety of Maternal Immunization.Pediatrics · 2021Article
- Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study.The Lancet. Infectious diseases · 2021Article
- Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women.Vaccine · 2020Article
- Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.Frontiers in immunology · 2020Review
- Measurement of birth outcomes in analyses of the impact of maternal influenza vaccination.Influenza and other respiratory viruses · 2019Article
- A Retrospective Cohort Study of Safety Outcomes in New Zealand Infants Exposed to Tdap Vaccine in Utero.Vaccines · 2019Article
- Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study.BMJ (Clinical research ed.) · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundThe variability of terms and definitions of Adverse Events Following Immunization (AEFI) represents a missed opportunity for optimal monitoring of safety of immunization in pregnancy. In 2014, the Brighton Collaboration Foundation and the World Health Organization (WHO) collaborated to address this gap.
methodsTwo Brighton Collaboration interdisciplinary taskforces were formed. A landscape analysis included: (1) a systematic literature review of adverse event definitions used in vaccine studies during pregnancy; (2) a worldwide stakeholder survey of available terms and definitions; (3) and a series of taskforce meetings. Based on available evidence, taskforces proposed key terms and concept definitions to be refined, prioritized, and endorsed by a global expert consultation convened by WHO in Geneva, Switzerland in July 2014.
resultsUsing pre-specified criteria, 45 maternal and 62 fetal/neonatal events were prioritized, and key terms and concept definitions were endorsed. In addition recommendations to further improve safety monitoring of immunization in pregnancy programs were specified. This includes elaboration of disease concepts into standardized case definitions with sufficient applicability and positive predictive value to be of use for monitoring the safety of immunization in pregnancy globally, as well as the development of guidance, tools, and datasets in support of a globally concerted approach.
conclusionsThere is a need to improve the safety monitoring of immunization in pregnancy programs. A consensus list of terms and concept definitions of key events for monitoring immunization in pregnancy is available. Immediate actions to further strengthen monitoring of immunization in pregnancy programs are identified and recommended.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.