Template protocol for clinical trials investigating vaccines—Focus on safety elements

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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.

Section: Preamblementioning

confidence: 99%

Section: Guidelinesmentioning

confidence: 99%

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

Jones

Muñoz

Spiegel

et al. 2016

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“…More detailed guidance on protocol development for clinical trials assessing vaccines is available elsewhere [13] (see Table 6). …”

Section: Guidance For the Collection Of Case Report Form Variablesmentioning

confidence: 99%

Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy

Jones

Muñoz

Kochhar³

et al. 2016

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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.

“…Better standardization and use of case definitions for AEFIs (e.g., as organized via the Brighton Collaboration) and toxicity grading scales allow greater accuracy and comparability needed for scientifically rigorous studies of vaccine safety (33). The Brighton Collaboration has also developed guidelines for standardized assessment of the safety elements in protocols of clinical trials investigating vaccines (34). For viral vector vaccines, a working group has been formed to anticipate and standardize assessment of potential safety issues, thereby facilitating their eventual public acceptance when licensed (35).…”

Section: Opportunities To Enhance the Evaluation Of Vaccine Safetymentioning

confidence: 99%

Enhancing vaccine safety capacity globally: A lifecycle perspective

Chen

Shimabukuro

Martín

et al. 2015

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Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th Century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved in the future to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle- income countries.