Sonali Kochhar

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

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.

Safety reporting in developing country vaccine clinical trials-A systematic review

With more vaccines becoming available worldwide, vaccine research is on the rise in developing countries. To gain a better understanding of safety reporting from vaccine clinical research in developing countries, we conducted a systematic review in Medline and Embase (1989-2011) of published randomized clinical trials (RCTs) reporting safety outcomes with ≥50% developing country participation (PROSPERO systematic review registration number: CRD42012002025). Developing country vaccine RCTs were analyzed with respect to the number of participants, age groups studied, inclusion of safety information, number of reported adverse events following immunization (AEFI), type and duration of safety follow-up, use of standardized AEFI case definitions, grading of AEFI severity, and the reporting of levels of diagnostic certainty for AEFI. The systematic search yielded a total number of 50 randomized vaccine clinical trials investigating 12 different vaccines, most commonly rotavirus and malaria vaccines. In these trials, 94,459 AEFI were reported from 446,908 participants receiving 735,920 vaccine doses. All 50 RCTs mentioned safety outcomes with 70% using definitions for at least one AEFI. The most commonly defined AEFI was fever (27), followed by local (16) and systemic reactions (14). Logistic regression analysis revealed a positive correlation between the implementation of a fever case definition and the reporting rate for fever as an AEFI (p=0.027). Overall, 16 different definitions for fever and 7 different definitions for erythema were applied. Predefined AEFI case definitions by the Brighton Collaboration were used in only two out of 50 RCTs. The search was limited to RCTs published in English or German and may be missing studies published locally. The reported systematic review suggests room for improvement with respect to the harmonization of safety reporting from developing country vaccine clinical trials and the implementation of standardized case definitions.

Global alignment of immunization safety assessment in pregnancy – The GAIA project

Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC. In the first year of the project, a large and functional network of experts was created. The first outputs include a guidance document for clinical trials of immunization in pregnancy, a basic data collection guide, ten case definitions of key obstetric and neonatal health outcomes, an ontology of key terms and a map of pertinent disease codes. The GAIA Network is designed as an open and growing forum for professionals sharing the GAIA vision and aim. Based on the initial achievements, tools and services are developed to support investigators and strengthen immunization in pregnancy programs with specific focus on LMIC.

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

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.

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data☆

ongenital anomalies: Case definition and guidelines for data ollection, analysis, and presentation of immunization safety data alini DeSilvaa, Flor M. Munozb, Mark Mcmillanc,d, Alison Tse Kawaie, Helen Marshalld, ristine K. Macartneyf,g, Jyoti Joshih, Martina Onekoi, Annette Elliott Rose j, Helen Dolkk, rancesco Trotta l, Hans Spiegelm, Sylvie Tomczykn, Anju Shresthao, Sonali Kochharp, lyse O. Kharbandaa,∗, The Brighton Collaboration Congenital Anomalies Working Group1

Stillbirth: Case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data ☆

No abstract available Keywords: Adverse event; Case definition; Fetal death; Guidelines; Immunization; Stillbirth.

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

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.

Postpartum haemorrhage: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

University of Liverpool, UK University of Washington, WA, USA Gynuity Health Projects, NY, USA Mowbray Maternity Hospital, South Africa Government Medical College and Hospital Nagpur, India University of Adelaide, Australia St George’s University of London, UK Barts and The London School of Medicine and Dentistry, UK Busitema University, Mbale Regional Referral Hospital, Uganda Global Healthcare Consulting, India

Non-reassuring fetal status: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Non-reassuring fetal status is a term used to describe suspected etal hypoxia and is meant to replace the more ubiquitous term fetal distress.” Fetal distress, defined as progressive fetal hypoxia nd/or acidemia secondary to inadequate fetal oxygenation, is a erm that is used to indicate changes in fetal heart patterns, reduced etal movement, fetal growth restriction, and presence of mecoium stained fluid [1]. Although fetal distress may be associated

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

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.