Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

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

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.

SUBMITTER: Jones CE

PROVIDER: S-EPMC5572188 | biostudies-other | 2016 Dec

REPOSITORIES: biostudies-other

ACCESS DATA

Json Xml

Similar Datasets

Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa.

Project description:BACKGROUND:A key consideration for expanding recommendations for influenza vaccination is a robust assessment of immunogenicity and efficiency of transplacental antibody transfer after maternal vaccination. METHODS:We pooled data from two trials of maternal influenza vaccination to analyze vaccine immunogenicity with more power than either trial had alone. We compared hemagglutination-inhibition (HAI) titers and titer factor change for women and their infants between trial arms using t-tests; maternal and infant putative seroprotective titers (HAI ? 1:40) within each trial arm and maternal seroconversion between trial arms using exact tests; and transplacental antibody transfer between trial arms using t-tests. We used marginal linear models and generalized estimating equations to examine the impact of time between maternal vaccination and delivery on transplacental antibody transfer, infant titers, and infant seroprotection. RESULTS:For all vaccine components (A/H1N1, A/H3N2, and Type B), >80% of vaccinated women had seroprotective titers, >60% of them seroconverted, and >50% of their infants were born with seroprotective titers. These immunogenicity outcomes occurred more often in vaccine recipients and their infants than in controls. No difference in efficiency of transplacental antibody transfer was observed between vaccine recipients and controls. CONCLUSIONS:Our results provide robust support for further expansion of maternal influenza vaccination recommendations. CLINICAL TRIALS REGISTRATION:NCT01430689 and NCT01306669.

| S-EPMC7505225 | biostudies-literature

Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

Project description:BackgroundUnpublished data can sometimes provide valuable information on the safety of biologic products.MethodsWe assessed information potentially available from regulatory authorities, manufacturers, and public health agencies. We explored 4 recently established vaccine registries, reviewed package inserts from 99 influenza vaccines, and contacted vaccine manufacturers and regulatory agencies for data on influenza vaccine safety in pregnant women.ResultsThe vaccine registries did not have sufficient data to analyze and there are problems with the quality of the information. The majority of package inserts provided no product-specific safety information for pregnant women, especially in less developed countries. The majority of available data come from reports gathered from passive adverse event reporting systems in the general population and reports of women enrolled in clinical trials of influenza vaccines who became pregnant at various times before or after receiving influenza vaccine. The information was not collected in a systematic manner, there are inconsistencies in the follow up of pregnant women and the available information about pregnancy outcomes. Considerable resources would be needed to systematically identify all of the information, try to obtain missing follow up information, and conduct analyses. There would be substantial limitations to any attempt to conduct a systematic analysis.ConclusionsThe value of trying to analyze unpublished data on the safety of influenza vaccine in pregnancy is limited and would require considerable resources to thoroughly investigate. Expanding efforts to identify and review unpublished data regarding the safety of influenza vaccines in pregnancy is not likely to produce information of high scientific value or information that could not be identified from publications and other publically available data.

| S-EPMC5647814 | biostudies-literature

Dysfunctional labor: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

Project description: Not available

| S-EPMC5710983 | biostudies-literature

Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

Project description:More than 40% of all deaths in children under 5 years of age occur during the neonatal period: the first month of life. Immunization of pregnant women has proven beneficial to both mother and infant by decreasing morbidity and mortality. With an increasing number of immunization trials being conducted in pregnant women, as well as roll-out of recommended vaccines to pregnant women, there is a need to clarify details of a neonatal death. This manuscript defines levels of certainty of a neonatal death, related to the viability of the neonate, who confirmed the death, and the timing of the death during the neonatal period and in relation to immunization of the mother.

| S-EPMC5139812 | biostudies-other

Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.

Project description:Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy.

| S-EPMC5139808 | biostudies-other

Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline.

Project description: Not available

| S-EPMC5590100 | biostudies-literature

Neonatal encephalopathy: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data.

Project description: Not available

| S-EPMC5710979 | biostudies-literature

Gestational diabetes mellitus: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

Project description: Not available

| S-EPMC5710985 | biostudies-literature

Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.

Project description:Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.

| S-EPMC5139809 | biostudies-literature

Low birth weight: Case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data.

Project description: Not available

| S-EPMC5710991 | biostudies-literature