GuidelineVaccine2016
Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.
Guideline in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05808166 (A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.), which is not on this map. Cited by 15 papers, 2 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.
A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- 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
- Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.BMC medical research methodology · 2017Trial
- Medical researchers' perception of sharing of metadata from case report forms.Learning health systems · 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
- Adverse infant outcomes following low-risk pregnancies in England: a retrospective cohort study.BMC pregnancy and childbirth · 2023Article
- Facilitating safety evaluation in maternal immunization trials: a retrospective cohort study to assess pregnancy outcomes and events of interest in low-risk pregnancies in England.BMC pregnancy and childbirth · 2022Article
- Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol.BMC pregnancy and childbirth · 2022Article
- 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
- Safety of Maternal Immunization Against Pertussis: A Systematic Review.Infectious diseases and therapy · 2019Review
- Current Challenges and Achievements in Maternal Immunization Research.Frontiers in immunology · 2018Review
- Safety assessment of immunization in pregnancy.Vaccine · 2017Article
- Article
- Immunization During Pregnancy: Impact on the Infant.Paediatric drugs · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy. The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.
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.