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Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

A phase III, randomised, observer-blind, placebo-controlled,
multicentre, clinical trial to assess the prophylactic efficacy, safety,
and immunogenicity of GSK Biologicals* herpes zoster gE/AS01B
candidate vaccine when administered intramuscularly on a twodose
schedule to adult autologous haematopoietic stem cell
transplant (HCT) recipients.

The purpose of this study is to test how well a new vaccine works to protect against shingles in people after they have received a transplant with their own blood stem cells.

MIPS Follow up - Local continuation of an observational, double-blind, follow up study as an extension of a randomised double-blind controlled study with a parallel group design on the effect of formula feeding (IF?FOF) supplemented with a mixture of immunologically active neutral and acidic oligosaccharides in healthy term born infants during their first year of life (during MIPS1) on the incidence of atopic diseases and infections around their 3rd year of life until the completion of their 7th

Has the supplementation of oligosaccharides in the first year of life an effect on the incidence of atopic diseases and infections from the 5th until the 7th year of life in healthy children

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the
pharmacokinetics, safety, and tolerability of multiple doses of orally administered
JNJ-53718678 in infants hospitalized with RSV infection

Primary Objectives:The primary objectives are to evaluate in infants who are hospitalized with RSV infection:- the pharmacokinetics of JNJ-53718678 after multiple oral doses;- the safety and tolerability of JNJ-53718678 when administered for 7 days.…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared toplacebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.

Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers

To determine the impact of prior BCG vaccination on the duration of immunogenicity of the BioNTech/Pfizer mRNA COVID*19 vaccine.

Exploratory study into age-related immunological differences related to immunogenicity in influenza vaccination and herpes zoster vaccination

The general objective of this study is to identify immune senescence related pathways leading to different immunogenicity after administration of unadjuvanted influenza or AS01 adjuvanted herpes zoster vaccines.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Primary ObjectiveThe primary objective is to evaluate superiority of pimodivir in combination with SOC treatment compared to placebo in combination with SOC treatment on Day 6, with respect to the clinical outcome on the hospital recovery scale.

Explorative study to the effect of BCG booster methods on the induction of trained innate immunity

The objective of the study is to determine the effect of BCG revaccination and high dose BCG vaccination on the induction and course of innate immune memory.

Coadministration of genetically attenuated Plasmodium falciparum *mei2 (GA2) sporozoites with adjuvants - a proof of principle study

This study has been transitioned to CTIS with ID 2024-516488-99-00 check the CTIS register for the current data. Primary objectives: 1. To assess the effect of experimental immunization with GA2 sporozoites by mosquito bite with and without co-…

COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older.

Objectives for the Randomized Observe-Blinded Phase:Primary Objectives:Primary Efficacy Objective• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any…

A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY
PARTICIPANTS >=5 YEARS OF AGE

This study has been transitioned to CTIS with ID 2023-509105-72-00 check the CTIS register for the current data. * To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary…

TBAJ-587-CL-001, Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-587 in Healthy Adult Participants.

PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…

The effect of methenamine hippurate to reduce antibiotic prescribing due to new episodes of urinary tract infections (UTI) in elderly women with recurrent UTI- a triple-blinded, randomized placebo-controlled phase IV study

Primary objective: The primary objective of this study is to investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI (measured as the number of courses of antibiotics).Secondary objectives:to investigate…

A randomised, double blind (sponsor unblinded), placebo-controlled, first time in human study to evaluate the safety, tolerability and pharmacokinetics of single and repeat oral doses and the food effect of GSK2556286 in healthy adult participants

To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…

A PHASE I, SPONSOR-OPEN, INVESTIGATORBLINDED,SUBJECT-BLINDED, MULTI-CENTER,
PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS
AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE
AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK
TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS
INFECTION

OBJECTIVESPrimary ObjectivesThe primary objective is:* To assess the safety and tolerability of 6 weeks of treatment with RO7020531 administered orally to virologically suppressed chronic hepatitis B (CHB) patients.Secondary ObjectivesThe secondary…

Exploring the early healing potential of a novel thermosensitive hyaluronic acid gel with octenidine preservation system as an adjunct to non-surgical periodontal treatment: a split-mouth blinded pilot study with proteomic analysis

This pilot study aims to assess the feasibility, safety and preliminary efficacy of a novel thermosensitive hyaluronic acid gel with an octenidine preservative system as an adjunct to standard non-surgical periodontal treatment. The use of a blinded…