A randomized controlled trial of influenza vaccine to prevent adverse vascular events.

Lead Research Organisation: McMaster University
Department Name: Faculty of Health Sciences

Abstract

Cardiovascular disease is a leading cause of death globally estimated to be responsible for approximately 17 million deaths annually. Heart disease and stroke account for nearly one third of all deaths and are a major cause of hospitalization. Patients with congestive heart failure (CHF) are at particularly high risk. Clinical trials demonstrate that nearly one third of patients with CHF will experience a myocardial infarction (MI), stroke, or hospitalization for CHF. Observational studies have established an association between influenza infection and major adverse vascular events . It follows that vaccinating such a high risk group as patients with CHF against influenza may prevent adverse vascular events. However, these studies are subject to bias and a well designed clinical trial is needed to test the effect of influenza vaccination on preventing adverse vascular events. The goal of this study is to assess whether inactivated influenza vaccine can reduce adverse vascular events in high risk participants. We will address the question by randomizing patients at high risk for adverse vascular events to either annual inactivated influenza vaccine or to placebo over three influenza seasons. The primary outcome is a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non- fatal stroke, and hospitalization for CHF. We will enroll 3,500 participants from centres in seven countries: Philippines (the lead centre), Mozambique, Sudan, Uganda, Saudi Arabia, Malaysia, China. This proposed randomized trial has important implications for the management of patients at high risk for major adverse vascular events. Although the influenza vaccine is recommended annually for groups with diabetes and cardiovascular disease in many counties, uptake of these recommendations is relatively low. Cardiologists in most jurisdictions do not routinely recommend annual influenza vaccine for their patients as a strategy to reduce future adverse vascular events such as acute coronary syndrome or stroke. Uptake of influenza vaccine in patients with heart disease varies by country but in INTER-CHF sites (where are trial will be conducted) is 11% on average. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events would represent a landmark study. We anticipate that such a trial would influence management decisions by physicians for patients at high risk for major vascular events. The effect size we propose testing is comparable to secondary prevention strategies available and given the fact that a vaccine is given once annually it is simple and inexpensive. Given the large burden of disease, the possibility to reduce cardiovascular and stroke related death is a compelling argument for this trial. If influenza vaccine is shown to reduce adverse vascular events, it will represent an important change in how prevention of adverse vascular events is thought about. The fact that our primary outcome is a composite, including various forms of vascular disease will increase generalizability. The study would be a milestone in contributing to evidence-based clinical as well public health policy.

Technical Summary

The goal of this study is to assess whether inactivated influenza vaccine can reduce adverse vascular events in high risk participants. We will address the question by randomizing patients at high risk for adverse vascular events to either annual inactivated influenza vaccine or to placebo over three influenza seasons. Participants will aged 18 years and over and have New York Heart Association functional class II, III and IV heart failure. Patients will be randomized to either influenza vaccine or placebo. We will enroll 3,500 participants from centres in seven countries: Philippines (the lead centre), Mozambique, Sudan, Uganda, Saudi Arabia, Malaysia, China. The primary outcome is a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non- fatal stroke, and hospitalization for CHF. We hypothesize that the intervention will lead to a 25% risk reduction in the primary outcome. This proposed randomized trial has important implications for the management of patients at high risk for major adverse vascular events. Although the influenza vaccine is recommended annually for groups with diabetes and cardiovascular disease in many counties, uptake of these recommendations is relatively low. Cardiologists in most jurisdictions do not routinely recommend annual influenza vaccine for their patients as a strategy to reduce future adverse vascular events such as acute coronary syndrome or stroke. Uptake of influenza vaccine in patients with heart disease varies by country but in study sites is 11% on average. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events would represent a landmark study.

Planned Impact

There are a wide variety of stakeholders that will benefit from this research. Firstly, patients at risk of cardiovascular disease will benefit by a potential reduction in adverse vascular events including unstable angina, myocardial infarction, stroke, and hospitalization for congestive heart failure. This alone represents a huge societal benefit. There are important quality of life implications if it can be proven that an annual vaccine prevents catastrophic cardiovascular events both for patients and their families. The uptake of influenza vaccination in this group is low in middle to low income countries, averaging about 10% or less. As the results will be broadly disseminated to vaccinators (i.e. physicians and public health officials), there will be a resultant greater uptake of influenza vaccination in at risk groups. Specific patient groups that will benefit include those at risk for heart failure, angina, myocardial infarction, and stroke. The burden of disease in the countries that we are targeting is huge. Globally, cardiovascular disease is responsible for 30% of the 17 million deaths that occur annually, with 80% of these deaths occurring in lower income countries. If our clinical trial shows a clinically important reduction in adverse vascular events, there will be a shift in cardiovascular prevention strategy where influenza vaccination will feature prominently. This will have an impact on primary care physicians, cardiologists, and infectious disease physicians, all of whom are stakeholders in that they are involved in vaccinating high risk patients. The findings of a reduction in adverse vascular events in a large well done randomized controlled trial due to influenza vaccination would lead to not only a pragmatic benefit, but also to a philosophical shift in thinking about cardiovascular disease. We do not believe that it is an exaggeration to say that the impact of this trial, should it show a reduction in adverse vascular events, will go well beyond that of the vast majority of funded studies that are done worldwide. The impact will be a key advance in knowledge about cardiovascular events and importantly about prevention. The economic impact for the prevention of even hospitalization for congestive heart failure alone would be enormous. Healthcare systems globally would benefit because the intervention, administration of an influenza vaccine, is likely to save costs. Health policy makers will be keenly interested in the results, including policy makers at the local, regional, national, and global levels. Scientists ranging from basic investigators, clinical scientists, economists, health policy analysts will benefit from our results. If a reduction in adverse vascular events is demonstrated, new avenues of inquiry will be opened in each of these fields. The results will be important to hospital administrators who have a vested interest in reduction of hospital admissions. The results of the study will change practise guidelines to emphasize the importance of influenza vaccination in high risk cardiovascular populations. Staff working on the project will benefit from enhancement of data management and organizational skills. Vaccine manufactures will benefit as well since the results will create new markets for the influenza vaccine. Students working on the grant (e.g. undergraduate, graduate, post-doc fellows) will benefit by exposure to a global study. The timescales for benefit would be short because the study would be conclusive about whether influenza vaccination can prevent adverse vascular outcomes.

Publications

10 25 50
 
Title IVVE Training Video Modules 
Description In order to provide training to various research teams from our international collaborating centers, we developed a series of training videos. The first video developed is for Manual of Operations and Procedures training. This video acts as a guide for site investigators and staff at centers involved in the study. The purpose of this video is to ensure consistency in protocol implementation and data collection by the site investigators, coordinators and nurses. The second video developed is for Vaccine Receiving, Storage and Monitoring. The purpose of this video is to provide training to the study teams on how to appropriately receive, store and handle the investigational product (influenza vaccine) in order to maintain the cold chain and adhere to clinical trials regulations. The third and final training video developed is for Screening, Enrollment, Randomization and Vaccination Procedures. This video provides a demonstration of the screening, enrollment and vaccination procedures required to conduct the study. 
Type Of Art Film/Video/Animation 
Year Produced 2016 
Impact In creating these videos and sharing them with all centers involved in the study, we have been able to successfully train a wide variety of research teams from multiple international centers. These videos have allowed for consistency in protocol implementation and data collection by the site investigators, coordinators and nurses. 
 
Description CIHR Foundation
Amount $165,000 (CAD)
Funding ID 148404 
Organisation Canadian Institutes of Health Research 
Sector Public
Country Canada
Start 07/2016 
End 06/2023
 
Title iDataFax Dataset 
Description The case report forms (CRFs) for this specific trial capture the following: baseline data, post-vaccination data (baseline, 12-month and 24-month visits), follow-up data (6-month, 18-month and 30-month visits), adverse event data, outcome events (stroke/TIA, myocardial infarction, hospitalization for heart failure), and unblinded allocation details (vaccine or placebo). The data for this clinical trial is captured using iDataFax which is an electronic data capture system used to collect and manage patient data and documents. The iDataFax system is designed for studies subject to regulatory review. The system includes: electronic signatures, password aging, reuse, complexity and lockout rules, fine-grained user permissions, audit trails, and secure 128 bit SSL encryption of all data and document transmissions over the internet. Data management for data control and completeness checks are preformed centrally by the coordinating center by trained personnel. All data is kept secure and confidentiality of all study participants is carefully protected. Data is collected on specifically designed case report forms (CRFs). Information is collected directly from the patient, their treating physician or through review of their medical records. The database has been set up with interactive data checks that will notify if a predefined error or criteria is met at the time of data entry. Subsequent checks and reports are run on a regular basis, once all data has been entered into the database. For analysis, data will be converted to SAS reports directly from the iDataFax database. SAS dataset are easily transferred to other groups if necessary via an in house secure file transfer protocol (SFTP) systems. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Use of this database in LMIC countries has served to closely link collaborating sites to the coordinating centre. The impact has been to provide sites with knowledge and experience of adapting and using a state of the art system for capturing data. 
URL http://www.datafax.com/software/idatafax/
 
Description Cameroon-Douala General Hospital 
Organisation Hospital General De Douala
Country Cameroon 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Ministry of Health (MOH) approval, and support for establishing of clinical trial agreements with all participating centers in Cameroon. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Ministry of Health (MOH) application for approval, and establishing of clinical trial agreements. In addition, the investigator at Douala General Hospital has been instrumental in identifying other enrollment centers in Cameroon.
Impact The investigator at Douala General Hospital identified other enrollment centers and assisted in the establishment of collaboration of one other institution from Cameroon. The enrollment sites in Cameroon did not recruit participants as they were not able to obtain local Ministry of Health approval. The list of enrollment centers from Cameroon are as follows: •Douala General Hospital •Central Hospital of Yaoundé
Start Year 2016
 
Description China-Fuwai Cardiovascular Hospital 
Organisation Fuwai Cardiovascular Hospital
Country China 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Project Evaluation (PE) approval, and support for establishing of clinical trial agreements with all participating centers in China. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission Project Evaluation (PE) application for approval, and establishing of clinical trial agreements. In addition, the investigators at Fuwai Cardiovascular Hospital have been instrumental in identifying other enrollment centers in China, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 694 participants in 2016 and 2017 across six enrollment sites in China. The investigators at Fuwai Cardiovascular Hospital identified other enrollment centers and assisted in the establishment of collaborations with five other institutions from China. The list of enrollment centers from China are as follows: •Fuwai Cardiovascular Hospital •Shandong Academy of Medicine Sciences •The Second Affiliated Hospital of Zhengzhou University •Hongqi Hospital of Mudanjiang Medical College •People's Hospital of Zunhua •Shenyang Dadong Wanghua Hospital
Start Year 2016
 
Description India-All India Institute of Medical Sciences 
Organisation All India Institute of Medical Sciences
Department Department of Cardiology
Country India 
Sector Learned Society 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Clinical Trial Registry India (CTRI) approval, support and feedback for Health Ministry Screening Committee (HMSC) approval and support for establishing of clinical trial agreements with all participating centers in India. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Clinical Trial Registry India (CTRI) application for approval, preparation and submission of Health Ministry Screening Committee (HMSC) application for approval, and establishing of clinical trial agreements. In addition, the investigator at All India Institute of Medical Sciences has been instrumental in identifying other enrollment centers in India, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 854 participants in 2016 and 2017 across six enrollment sites in India. The investigator at All India Institute of Medical Sciences identified other enrollment centers and assisted in the establishment of collaborations with five other institutions from India. The list of enrollment centers from the India are as follows: •All India Institute of Medical Sciences •Indira Gandhi Medical College •Dayanand Medical College and Hospital •Govind Ballabh Pant Institute of Postgraduate Medical Education and Research •Eternal Heart Care Centre & Research Institute •King Georges's Medical College
Start Year 2016
 
Description Kenya-Aga Khan University Hospital, Nairobi 
Organisation Aga Khan University Hospital, Nairobi
Country Kenya 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Pharmacy Poisons Board (PPB) approval, and support for establishing of clinical trial agreements. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Pharmacy Poisons Board (PPB) application for approval, and establishing of clinical trial agreements. In addition, the investigator at Aga Khan University Hospital, Nairobi has been instrumental in providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 116 participants in 2016 and 2017.
Start Year 2016
 
Description Lebanon-American University of Beirut Medical Center 
Organisation American University of Beirut Medical Center
Country Lebanon 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Ministry of Health (MOH) approval, and support for establishing of clinical trial agreements with all participating centers in Lebanon. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Ministry of Health (MOH) application for approval, and establishing of clinical trial agreements. In addition, the investigator at American University of Beirut Medical Center has been instrumental in identifying other enrollment centers in Cameroon.
Impact The investigator at American University of Beirut Medical Center identified other enrollment centers and assisted in the establishment of collaboration of one other institution from Lebanon. The enrollment sites in Lebanon have received ethical approval and will enroll in 2018. The list of enrollment centers from Cameroon are as follows: •American University of Beirut Medical Center •Rafik Hariri University Hospital
Start Year 2017
 
Description Mozambique-Maputo Central Hospital 
Organisation Maputo Central Hospital
Country Mozambique 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Central de Medicamentos e Artigos Médicos (CMAM) clearance, and support for establishing of clinical trial agreements with all participating centers in Mozambique. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Central de Medicamentos e Artigos Médicos (CMAM) application for approval, and establishing of clinical trial agreements. In addition, the investigator at Maputo Central Hospital has been instrumental in identifying other enrollment centers in Mozambique, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 280 participants in 2016 and 2017. The investigator at Maputo Central Hospital identified other enrollment centers and assisted in the establishment of collaboration with one other institution from Mozambique. The list of enrollment centers from Mozambique are as follows: •Maputo Central Hospital •Instituto Nacional de Saude (National Institute of Health)
Start Year 2016
 
Description Nigeria-Bayero University Kano 
Organisation Bayero University Kano
Department Department of History
Country Nigeria 
Sector Academic/University 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for National Agency for Food and Drug Administration and Control (NAFDAC) approval, and support for establishing of clinical trial agreements with all participating centers in the Nigeria. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of National Agency for Food and Drug Administration and Control (NAFDAC) application for approval, and establishing of clinical trial agreements. In addition, the investigator at Bayero University Kano has been instrumental in identifying other enrollment centers in Nigeria, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 717 participants in 2016 and 2017 across four enrollment sites in Nigeria. The investigator at Bayero University Kano identified other enrollment centers and assisted in the establishment of collaborations with three other institutions from Nigeria. The list of enrollment centers from Nigeria are as follows: •Bayero University Kano (Aminu Kano Teaching Hospital) •Murtala Muhammad Specialist Hospital •University College Hospital, Ibadan •Obafemi Awolowo University (OAU) and OAU Teaching Hospitals Complex
Start Year 2016
 
Description Philippines-University of Philippines Manila 
Organisation University of Philippines Manila
Department National Institute of Health
Country Philippines 
Sector Academic/University 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Food and Drug Administration (FDA) approval, and support for establishing of clinical trial agreements with all participating centers in the Philippines. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Food and Drug Administration (FDA) application for approval, and establishing of clinical trial agreements. In addition, the investigators at University of Philippines Manila have been instrumental in identifying other enrollment centers in the Philippines, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 516 participants in 2016 and 2017 across four enrollment sites in the Philippines. The investigators at University of Philippines Manila identified other enrollment centers and assisted in the establishment of collaborations with three other institutions from the Philippines. To allow for the increased sample size to be met, the investigators at University of Philippines Manila have identified two new sites who are in the process of obtaining necessary approvals to enroll patients in 2018. The list of active enrollment centers from the Philippines are as follows: •University of Philippines Manila (Philippines General Hospital) •Ospital Ng Makati •De La Salle Health Sciences Institute •East Avenue Medical Center
Start Year 2016
 
Description Saudi Arabia-King Khalid University Hospital 
Organisation King Khalid University Hospital, Riyadh
Country Saudi Arabia 
Sector Academic/University 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for Saudi Food and Drug Authority (FDA) approval, and support for establishing of clinical trial agreements with all participating centers in Saudi Arabia. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Saudi Food and Drug Authority (FDA) application for approval, and establishing of clinical trial agreements. In addition, the investigator at King Khalid University Hospital has been instrumental in identifying other enrollment centers in Saudi Arabia, providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 311 participants in 2016 and 2017 across three enrollment sites Saudi Arabia. The investigator at King Khalid University Hospital identified other enrollment centers and assisted in the establishment of collaborations with three other institutions from Saudi Arabia. The Medinah Cardiac Center site did not enroll due to changes in institutional policies that require all cardiac patients to receive the influenza vaccine. The list of active enrollment centers from Saudi Arabia are as follows: •King Khalid University Hospital (King Fahad Cardiac Centre) •King Fahad Medical City •King Abdulaziz University Hospital
Start Year 2016
 
Description Uganda-Mulago Hospital 
Organisation Mulago National Referral Hospital
Country Uganda 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for National Drug Authority (NDA) approval, and support for establishing of clinical trial agreements. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of National Drug Authority (NDA) application for approval, and establishing of clinical trial agreements. In addition, the research team at Mulago Hospital successfully recruited participants into the trial.
Impact This collaboration has resulted in recruitment of 59 participants in 2016. The site was unable to continue recruitment of new participants as the investigator moved to a different institution and regulatory re-approval was not received. The site is in the process of obtaining follow up information for the 59 participants enrolled.
Start Year 2016
 
Description United Arab Emirates-Sheikh Khalifa Medical City 
Organisation Sheikh Khalifa Medical City
Country United Arab Emirates 
Sector Hospitals 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, support and feedback for import permit approval, and support for establishing of clinical trial agreements. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of import permit application for approval, and establishing of clinical trial agreements. In addition, the investigators at Sheikh Khalifa Medical City have been instrumental in providing enrollment strategy guidance, as well as successfully recruiting participants for the trial.
Impact This collaboration has resulted in recruitment of 20 participants in 2016 and 2017.
Start Year 2016
 
Description Zambia-University of Zambia 
Organisation University of Zambia
Country Zambia 
Sector Academic/University 
PI Contribution We have contributed to this collaboration by providing extensive protocol development, clinical trials experience, support and feedback for ethical committee approval, as well as support and feedback for Zambia Medicines Regulatory Authority(ZAMRA) approval. In addition, we have provided the following training: clinical trials compliance training, Good Clinical Practice (GCP) training, Manual of Operations and Procedures (MOP) training, as well as vaccine shipment and management training.
Collaborator Contribution The contributions made by our partners to this collaboration include extensive protocol development, preparation and submission of ethical committee applications for approval, preparation and submission of Zambia Medicines Regulatory Authority(ZAMRA) application for approval and establishing of clinical trial agreements.
Impact This collaboration has resulted in recruitment of 201 participants in 2017.
Start Year 2017
 
Title VAXIGRIP® influenza vaccine 
Description VAXIGRIP® is a licensed and marketed Sanofi Pasteur vaccine used for the prevention of influenza infection. It is licensed in all of the countries participating in this clinical trial. VAXIGRIP® for intramuscular use, is a sterile suspension containing 3 strains of influenza virus cultivated on embryonated eggs, concentrated, purified by zonal centrifugation in a sucrose gradient, split by Triton® X -100, inactivated by formaldehyde and then diluted in phosphate buffered saline solution. The type and amount of viral antigens contained in VAXIGRIP® conform to the current requirements of the World Health Organization (WHO). VAXIGRIP® is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults and children 6 months of age and older. Although the current influenza vaccine can contain one or more of the antigens administered in previous years, annual vaccination using the current vaccine is necessary because immunity declines in the year following vaccination. 
Type Therapeutic Intervention - Vaccines
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Although it is too early for us to describe the impact of the intervention, which is a fully developed vaccine, for a novel indication, the process of bringing together a diverse group of researchers from LMICs has led to an impact on their research infrastructure and has allowed them to gain insights from being part of this consortium. For example, this has led to training and networking opportunities. 
URL https://www.vaccineshoppecanada.com/document.cfm?file=vaxigrip_e.pdf
 
Title iDataFax Technology - Global Use 
Description iDataFax is an electronic data capture system used to collect and manage patient data and documents. The iDataFax system is designed for studies subject to regulatory review. The system includes: electronic signatures, password aging, reuse, complexity and lockout rules, fine-grained user permissions, audit trails, and secure 128 bit SSL encryption of all data and document transmissions over the internet. 
Type Of Technology Software 
Year Produced 2016 
Open Source License? Yes  
Impact Although the iDataFax software is not a new technology, global of this system in LMIC countries has served to closely link collaborating sites to the coordinating centre. The impact has been to provide sites with knowledge and experience of adapting and using a state of the art system for capturing data. 
URL http://www.datafax.com/software/idatafax/
 
Description Does the flu lead to heart attacks? Dr. Tom Marrie Lectureship 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact A lecture to professional practitioners regarding the IVVE trial which resulted in discussion afterwards.
Year(s) Of Engagement Activity 2019
 
Description IVVE - Annual Investigator's Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The annual IVVE investigator's meeting was held in Paris, France. The purpose of the talk was to provide an overview of the IVVE trial and prompt discussion afterwards.
Year(s) Of Engagement Activity 2019
 
Description Influenza and the heart. PHRI 20th Anniversary Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact A talk on the IVVE trial which prompted discussion and questions related to influenza and cardiovascular research.
Year(s) Of Engagement Activity 2019