GuidelineVaccine2016
Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.
Guideline in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 6 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
28 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Guideline
- Guideline
- Guideline
- Dysfunctional labor: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.Vaccine · 2017Guideline
- 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
- A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions.BMC pregnancy and childbirth · 2026Observational
- Protecting mother and baby: Learnings from an Ebola vaccination campaign on the evolving landscape of vaccines and pregnancy.PLoS medicine · 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
- Article
- Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS).BMC pregnancy and childbirth · 2023Review
- The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations.Drug safety · 2023Article
- Preparing for Disease X: Ensuring Vaccine Equity for Pregnant Women in Future Pandemics.Frontiers in medicine · 2022Article
- Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database.Drug safety · 2021Article
- A reasoned approach towards administering COVID-19 vaccines to pregnant women.Prenatal diagnosis · 2021Review
- Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review.BMC pregnancy and childbirth · 2021Article
- Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women.Vaccine · 2020Article
- Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali.Reproductive health · 2020Article
- Causality assessment of adverse events following immunization: the problem of multifactorial pathology.F1000Research · 2020Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.
Indexed as
Identifiers
What OpenQuestion holds
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.