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The Supported Studies Programme

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Vaccines



Timelines





Please find below the current areas of interest for Vaccine Human Subject Research - 2023 Cycle 1.



[RSV & RSV vaccination in vulnerable groups (adults with health conditions, older adults 60 years of age and older)]

·RSV immunology/biology and correlates of protection in natural infections
·Epidemiology of RSV: incidence, transmission, reinfection, estimates of under-diagnosis
·Studies to understand the medical & economic burden, and impact of RSV to patients, caregivers in different healthcare settings, including long-term care facilities
·Studies to understand barriers and attitudes to RSV vaccination
·Clinical studies evaluating the safety and/or immunogenicity of RSV vaccination in specific at-risk populations, concomitantly or not with other vaccines or therapeutic regimen
·Effectiveness of RSV vaccination

Key criteria for Supported Studies assessment include vaccine availability & regulatory authorisation in the population in scope


[Neisseria]

•RWE on impact of 4CMenB vaccination program on MenB epidemiology and non B epidemiology
•4CMenB booster dose in individuals primed as infants or young children
•Impact of different vaccination schedules (MenB vaccines) on compliance and completion of adolescent vaccination program


[Influenza (pandemic & seasonal)]

•Vaccination coverage overall, for quadrivalent influenza vaccines (QIVs), for brand specific vaccines, in WHO- identified risk groups
•Co-administration studies


[Adult Immunisation]

•Studies assessing the challenges and solutions to implement life course immunization
•Studies on vaccination coverage for vaccines recommended in adults, including high-risk groups
•Studies on health care utilization related to the management of infectious diseases in the hospital and post-discharge care settings
•Studies on quality of life and dependency or other socio-economic consequences following an episode of infectious diseases and vaccine preventable diseases in older adults
•Studies on the impact or potential impact of adult vaccination on health inequalities
•Studies measuring the impact of communication and educational interventions on vaccine coverage in adults
•Studies on the aging parameters of the immune system and how they impact the immune response to vaccines of older adults
•Communication between Healthcare Professionals and patients


[Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Poliomyelitis]

•Real world evidence of DTPa-combinations, in general and special populations.
•Pertussis burden of diseases/Health Economic studies
•Impact of Pertussis Maternal Immunisation
•B. pertussis nasopharyngeal carriage
•HiB carriage


[Rotavirus]

•Rotavirus (RV) Disease Burden Impact of RV vaccination and schedules (Compliance, completion, coverage)
•Exploring new and innovative approaches for improving Rotavirus Vaccination coverage
•Added benefits of Rotavirus vaccination


[Streptococcus pneumoniae]

•Impact / effectiveness of Haemophilus influenzae protein-D conjugated pneumococcal vaccine (on overall disease, Pneumonia, Otitis)


[Hepatitis]

ISS areas of interest for Hepatitis A and B in 2023

•Economic evaluation and societal impact of hepatitis A outbreaks
•Hepatitis A/B seroprevalence data in specific populations
•Hepatitis A/B burden of disease in adults
•Use of hepatitis vaccines in adult risk groups and other susceptible populations (including, coverage rates, knowledge, attitudes and practices medical surveys)
•Impact of Hepatitis A/B universal vaccination


[Herpes Zoster]

•Studies to assess the incidence and burden of disease of HZ, impact of HZ and its complications on quality-of-Life measures, interference in daily activities, health care costs
•Studies to assess the awareness of risk and impact of shingles, post-herpetic neuralgia (PHN) and other herpes zoster (HZ) complications in at-risk adults (including adults at risk due to age-related decline in immunity and those at increased risk due to underlying disease and/or therapy)
•Studies to understand barriers and attitude to vaccination against herpes zoster in non-interventional study setting
•Studies providing insights into the mechanism of action of RZV vaccination
•Studies to assess the risk of complications (other than PHN)
•Effectiveness and real-world impact of RZV vaccination
•Evaluations of safety and/or immunogenicity and/or efficacy of the recombinant zoster vaccine in at-risk populations

Reminder: GSK Vaccines supply availability is one of the key criteria in the assessment of the Supported Studies proposals received


[Human Papillomavirus]

•Real world evidence of the AS04 adjuvanted Human Papillomavirus vaccine


[Measles, Mumps, Rubella, Varicella (MMR/V)]

•Impact of MMRV combination vaccines on vaccine coverage
•Impact of varicella prevention programs
•Effectiveness of GSK MMR vaccine (Measles/Mumps)
•Burden and severity of Varicella disease

Although GSK are more likely to support studies aligned to our current areas of interest for supported studies, we are interested in supporting studies that are innovative and contribute to scientific knowledge relating to a product, a medical condition or advancing a technology.



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