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The Supported Studies Programme
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Please find below some of the current areas of interest for Vaccines Human Subject Research. We are also interested in non-Human Subject Research studies. These were last updated in May 2019.

[Across Diseases & Technologies (Adjuvant System, Immunostimulants, etc.)
General Vaccine Science, life course immunization]
• Studies on societal and economic barriers for providers and population to vaccine uptake beyond paediatric population
• Studies assessing overall impact of infectious diseases (IDs) and all vaccines preventable IDs in older adults' morbidity and mortality, in relation to the frailty index
• Studies on the aging parameters of the immune system (immunosenescence) and how they impact the immune response to vaccines of older adults versus young people
• Health Economic assessments of role of vaccine to support healthy aging
• Studies measuring the impact of communication and educational interventions (in particular if delivered in a digital format) on vaccine uptake, in particular in pregnant women and adults
• Studies on understanding the immune responses during pregnancy and how that relates to vaccination
• Studies assessing the challenges and solutions to implement life course immunization, including behavioural economics
• Studies on vaccination coverage for all vaccines recommended in a target population (e.g. flu, Tdap, PVC, zoster etc in older in adults).

[Chronic Obstructive Pulmonary Disease (COPD)]
• Bacteria and virus prevalence in COPD exacerbations
• Impact of the lung microbiome on COPD exacerbations, including the pathogenic role of NTHi, Mcat as well as lung immuninity
• Bacteria and virus interaction in COPD exacerbations
• Identification of biomarkers to assess the risk of COPD exacerbations caused by bacterial and viral infections
• Perceptions on vaccination and vaccination uptake in clinical management of COPD patient

[Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (HiB), Poliomyelitis]
• Vaccine effectiveness or impact data, on pertussis, HiB and hepatitis disease following use of DTPa-combinations, including in special populations.
• Pertussis burden/Health Economic models in young infants, older children, adolescents, adults , older adults and patients with chronic diseases.
• Pertussis Maternal Immunisation: effectiveness, safety, maternal antibodies and impact on primary vaccination.

[Hepatitis A]
• Impact of Hepatitis A universal mass vaccination on burden of disease
• Hepatitis A seroprevalence data
• Epidemiological dynamic models to predict endemicity shift
• Data on impact of Hepatitis A delayed booster administration

[Hepatitis B]
• Impact of Hepatitis B vaccination on type 2 diabetes disease outcomes
• Observational studies to assess vaccine coverage and awareness of risk of Hepatitis B infection among Chronic Kidney Disease patients and their Health Care providers

[Herpes Zoster]
Immunocompetent Older Adults (50 years of age and older)

• Innovative solutions to improve 2-dose completion and series compliance
• Observational studies to assess the awareness of: risk of shingles, post-herpetic neuralgia (PHN) and other herpes zoster (HZ) complications in older adults
• Observational studies to assess the incidence of HZ, impact of HZ and complications on Quality of Life (QoL) measures, role of caregivers, interference in daily activities, health care costs etc.
• Studies providing insights into the Mechanism of Action (MoA) and protection

[Herpes Zoster]
At-Risk/Immunocompromised Adults (18 years of age and older)

• Evaluations in autoimmune populations (eg. Inflammatory Bowel Diseases, Psoriasis, Lupus, Multiple Sclerosis)
• Evaluations of vaccination in the context of immunomodulating treatments (eg. TNF-inhibitors, JAK-inhibitors)
• Observational studies to assess the incidence of HZ, impact of HZ and complications on exacerbation/de-stabilization of co-morbid conditions (e.g Type2Diabetes, COPD), QoL and cost of HZ complications
• Studies providing insights into the Mechanism of Action (MoA) and protection
• Observational studies to assess awareness of the risk of shingles, PHN and other HZ complications in immunocompromised (IC) populations (HIV infected patients, immunosuppressed patients, etc.) or other adult individuals with chronic diseases (such as Type2Diabetes, COPD)
• Assessments of willingness of HCPs who treat co-morbidities to vaccinate
• Evaluations immunocompromised populations (eg. Allo-HSCT, HIV, Kidney Failure/ESRD)
• BOI studies (population and country-specific data gaps only)

NOTE: Studies requiring vaccine and/or placebo will be reviewed with additional considerations based on vaccine supply and commercial availability in the proposed country of research conduct

[Human Papillomavirus (HPV)]
• Effectiveness or impact of Human Papillomavirus vaccines against vaccine and non-vaccine types and duration of cross protection
• Effectiveness of Human Papillomavirus vaccine on non-cervical cancers and pre-cancerous lesions/infections
• Alternative schedules for Human Papillomavirus vaccine (e.g. mixed schedule, 1-dose)
• Impact of adjuvant in Human Papillomavirus vaccine on humoral and cellular immune responses
• Immunogenicity, efficacy, safety in specific populations (immunocompromised, males etc.)

[Influenza (pandemic & seasonal)]
• Evaluation of disease severity characterisation in different age groups
• Vaccination coverage overall, for QIVs, for brand specific vaccines, in WHO identified risk groups
• Co-administration studies in paediatric patients
• Maternal immunisation outcomes in mothers and children
• Burden of disease studies in European children

[Measles, Mumps, Rubella, Varicella (MMRV)]
• Impact of MMRV combination vaccines on Varicella and MMR coverage
• Impact of varicella prevention programs (complications, hospitalization, costs)
• Effectiveness of GSK MMR vaccine (Measles/Mumps)
• Burden and severity of Varicella disease
• Evidence to better understand the interplay between Varicella programs and herpes zoster disease (role of endogenous/exogenous boosting)
• MMR/V vaccination strategies (early protection, age groups)

• Effectiveness or impact data after MenACWY vaccination in 2+1 schedule in infants
• Effectiveness or impact data after MenACWY-CRM vaccination with one dose schedule in toddlers 12-23 months
• Effectiveness or impact data after Meningococcal vaccination in older adults ( > 65 years)
• Immunogenicity data after MenB and MenACWY co-administration in infants and adolescents
• Persistence data following MenB vaccination in infants and adolescent
• Co-administration data following MenB vaccination in adolescents
• MenB vaccination impact on carriage
• Effectiveness and impact of MenB vaccination program

[Streptococcus pneumoniae]
• Comparison of impact between different PCVs
• Mechanism of action of Haemophilus influenzae protein-D conjugated vaccines. This can include NTHi transmission and disease in children, carriage studies or modelling, helping understand impact on herd protection and replacement disease
• Impact of Haemophilus influenzae protein-D conjugated vaccines on pneumonia, otitis media or antibiotic prescription
• Studies of the effects of Haemophilus influenzae protein-D conjugated vaccines in at risk populations <18 years of age

• Rotavirus Disease Morbidity Burden ( e.g.: Burden on healthcare resources, hospitalization, medical visits, nosocomial disease due to Rotavirus (Age stratified where possible, especially < 6 months) provided local/regional data are non-existent
• Impact Studies of RV vaccination on Rotavirus Gastroenteritis hospitalization, Emergency Department / outpatient/ General Physician visits, Cost reduction, Nosocomial Rotavirus Gastroenteritis including assessment of herd effects.
• Impact of 2 doses on compliance and timely completion on morbidity/ mortality and on Rotavirus vaccine coverage (pre- and post-rotavirus vaccine)
• Improving Rotavirus Vaccine coverage: Impact of different vaccination schedules/strategies
• Health Economic budget impact analysis to demonstrate impact on health care cost and affordability of Rotavirus vaccination
• Rotavirus Vaccination Value assessment:
• Quality of care benefits
• Reduction in absenteeism
• Added Benefits of Rotavirus vaccination beyond RVGE prevention (e.g. febrile convulsions)
• Safety and Impact of Rotavirus vaccination on Preterm infants

[Traveler Vaccination]
• Observational studies, including Knowledge Attitude and Practices (KAP) surveys, to assess acceptance of travel vaccination, vaccine coverage and disease awareness (Hepatitis A/B, Rabies and Tick Borne Encephalitis) amongst travellers and Health Care Professionals
• Knowledge Attitude and Practices surveys (Hepatitis A/B, Rabies and Tick Borne Encephalitis )
• Hepatitis A and Hepatitis B seroprevalence in specific travel populations such as Visiting Friends & Relatives; immigrants and refugees older adult travellers and flashpackers
• Rabies novel vaccination schedules including changes to number of doses, mode of administration or timing and impact on travellers

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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