ArticleVaccine2017
Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.
Article in Vaccine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Facilitators and barriers to maternal immunization and strategies to improve uptake in low-income and lower-middle income countries: A systematic review.Human vaccines & immunotherapeutics · 2024Pooled it
- A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions.BMC pregnancy and childbirth · 2026Observational
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- 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
- "If it benefits someone, it will be good:" perspectives on research participation from pregnant women living with HIV.AIDS care · 2023Article
- Article
- Maternal vaccination: a review of current evidence and recommendations.American journal of obstetrics and gynecology · 2022Review
- The promise, problems, and pitfalls of including pregnant women in clinical trials of Lassa fever vaccine: a qualitative assessment of sub-Sahara Africa investigators' perception.The Pan African medical journal · 2022Article
- 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
- Group B streptococcal disease in the mother and newborn-A review.European journal of obstetrics, gynecology, and reproductive biology · 2020Article
- 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
- Safety of Administering Live Vaccines During Pregnancy: A Systematic Review and Meta-Analysis of Pregnancy Outcomes.Vaccines · 2020Review
- Article
- Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations.Vaccine · 2019Review
- Serologic Tools and Strategies to Support Intervention Trials to Combat Zika Virus Infection and Disease.Tropical medicine and infectious disease · 2019Review
- Safety assessment of immunization in pregnancy.Vaccine · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally.
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.