CTRI/2022/07/044219Completed未知
Evaluation of efficacy and safety of Quadrivalent Influenza Vaccine (FluQuadri TM) in patients with Inflammatory Bowel Disease (IBD) â?? a case-control proof of concept study
Seth GS Medical College and KEM Hospital0 sites75 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Male or female of no childbearing potential 18 years and above at the time of study vaccine administration.
- •2.Provide written informed consent.
- •3.The participant is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
- •4.Patients listed in IBD registry at Department of Medical Gastroenterology with moderate-severe disease activity
- •5.Patient on an immunomodulator and/or immunosuppressants and/or corticosteroids on a stable dose for at least the last 3 months
- •4.Healthy, or with well controlled re-existing medical condition [for example well controlled diabetes and hypertension] as determined by medical history and clinical assessment of the investigator.
Exclusion Criteria
- •1.Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-revaluated for eligibility).
- •2.Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-evaluated for eligibility.
- •3.Not willing to refrain from physical exercise during 12 hours prior to vaccination.
- •4.History of any influenza vaccine administration during the past 6 months prior to the present study.
- •5.Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis at screening visit.
- •6.Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection within 6 months prior to vaccination.
- •7.History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component
- •8.Previous history of Guillain Barre Syndrome.
- •9.Any confirmed or suspected condition with impaired/altered function of immune system (e.g., immunodeficient or autoimmune conditions) based on history and clinical examination
- •10.Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator based on history and clinical examination
- •11.Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease-free for >=5 years).
- •12.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
- •13.Administration of any vaccine within 28 days prior to enrolment in the study (except for influenza vaccine which should be >6 months prior to enrolment in the study) or planned administration of any vaccine during study participation.
- •14.Have received systemic antibiotic treatment within 3 days prior to enrolment.
- •15.Patients on any biologic agents
- •16.Patients taking any Immunomodulator and/or immunosuppressant and/or corticosteroids for diseases other than IBD.
- •17.IBD patients with major significant comorbidities or illnesses like chronic kidney disease, congestive heart failure, liver cirrhosis, malabsorption syndrome, severe malnutrition, short bowel syndrome etc which in the purview of the investigator can compromise the safety of the participant or alter the vaccine efficacy.
- •15.Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, >= 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed.
Investigators
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