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Vaccine Reaction clinical trials

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NCT ID: NCT06385821 Completed - Influenza Clinical Trials

A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus

Start date: September 21, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".

NCT ID: NCT06252051 Completed - Diabetes Mellitus Clinical Trials

Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)

Start date: January 5, 2021
Phase: Phase 4
Study type: Interventional

This study assesses the effectiveness of the seasonal flu vaccine in individuals with Type 2 Diabetes Mellitus (T2DM) with and without Chronic Kidney Disease (CKD), as well as in healthy individuals. Additionally, the study investigates the dynamics of cytokines, specifically IL-2 and IL-6, in the three groups following influenza vaccination. The findings from these studies will contribute to our understanding of the safety and efficacy of the influenza vaccine in T2DM and T2DM-CKD, shedding light on inflammation changes and informing future research on mitigation strategies.

NCT ID: NCT05869201 Completed - Influenza Clinical Trials

Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine

Start date: October 6, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60. Participants were given Flu-M Quadro [inactivated split influenza vaccine] with preservative or Flu-M Quadro [inactivated split influenza vaccine] without preservative or Ultrix® Quadri vaccine.The volunteers of each group were vaccinated with a single dose vaccine. Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine. Researchers performed a comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the Ultrix® Quadri vaccine.

NCT ID: NCT05515081 Completed - Vaccine Reaction Clinical Trials

Antibody Response and Longevity Post SARS-CoV-2 Vaccine (SARS-AB)

SARS-AB
Start date: May 21, 2021
Phase: N/A
Study type: Interventional

Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. In the event of the administration of a third dose, the participants already recruited will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6, 8 and 12 months). A laboratory serological test will be performed for each sample. The expression of humoral biomarkers will be evaluated with the Luminex methodology with the aim of identifying prognostic and predictive biomarkers of the response to the vaccine.

NCT ID: NCT05270967 Completed - Oncology Clinical Trials

FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination

fdg
Start date: July 29, 2021
Phase:
Study type: Observational

It is important to evaluate the vaccine-related metabolic changes on FDG PET/CT to avoid confusing results. The investigators aimed to assess the frequency and intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (BNT162b2-Pfizer/BioNTech) and to analyze possible factors affecting these changes.

NCT ID: NCT05268185 Completed - COVID-19 Clinical Trials

The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19)

BOOSTED
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

While both heterologous (mixing) and homologous (matching) vaccine regimens are now considered standard of care, post-vaccination complications and long-term effects of the different vaccination regimens have not been thoroughly studied. There is a pressing need to investigate the longitudinal effects of the mixing and matching vaccine-booster approaches. This study proposes to utilize the existing digital infrastructure of the COVID-19 Citizen Science (CCS) study on the Eureka Research Platform to perform a systematic and prospective randomized trial comparing mixing versus matching approaches. Eligible CCS participants will have the opportunity to be randomly assigned to a recommendation of receiving either the Pfizer or Moderna booster vaccine. Long-term effects will be monitored through the participants' completion of their regular weekly CCS follow-up surveys on symptoms and infection. This randomized trial aims to mitigate the effect of confounding variables and provide more conclusive evidence on each regiment to guide booster recommendations.

NCT ID: NCT05228912 Completed - COVID-19 Clinical Trials

Immunization of 7 Different Vaccines Against SARS-COV-2 Across 4 Countries.

Start date: February 26, 2021
Phase:
Study type: Observational [Patient Registry]

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-COV2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers are being measured at baseline, 21-28 days after the first and second dose (when applicable), six months and a year of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models will be performed for the analyses.

NCT ID: NCT05168709 Completed - COVID-19 Clinical Trials

Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction

COSI BAIR
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination. Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI): 1. Day 0 - baseline (day of COVID-19 vaccination #1), and 2. Day 84 (28 days after COVID-19 vaccination #2).

NCT ID: NCT05154383 Completed - Vaccine Reaction Clinical Trials

Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

INFLUOMICS
Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

NCT ID: NCT05116748 Completed - COVID-19 Clinical Trials

COVID19 Vaccine in SOT Adult Recipients

COVID19_VaxSOT
Start date: October 1, 2021
Phase:
Study type: Observational

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: - T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status - Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination - T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity - Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity