EUCTR2014-003007-29-BEActive, not recruitingPhase 1
The Polysaccharide Antibody Response Study: Typhim Vi response and allohemagglutinins versus Pneumo 23 vaccine response in the diagnosis of Specific Polysaccharide Antibody Deficiency. - PAR-study
niversity Hospitals Leuven, department of pediatrics0 sitesStarted: July 24, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects, in whom humoral immunity is evaluated, will be included in cohort 1 when the below-mentioned criteria are fulfilled.
- •Assessment of polysaccharide antibody response is indicated for the clinical care of the patient
- •Age between 18 months and 55 years
- •Informed consent given
- •Healthy volunteers, recruited at the travel clinic and by advertising, will be included in cohort 2 when the below-mentioned criteria are fulfilled.
- •Age between 18 months and 55 years
- •Informed consent given
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Age >55 years
- •Age <18 months
- •History of serious adverse reaction to a vaccine
- •Vaccination with Typhim or Pneumovax 23 in 5 years prior to the study
- •Pregnancy
Investigators
Similar Trials
Completed
Phase 4
Polysaccharide Antibody Response StudySpecific Polysaccharide Antibody DeficiencyNCT02429531Universitaire Ziekenhuizen KU Leuven200
Active, not recruiting
Not Applicable
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and ToddlersPneumococcal DiseaseMedDRA version: 17.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004179-22-Outside-EU/EEAWyeth, A Pfizer Company335
Recruiting
Not Applicable
IgG-subclass and/or antipolysaccharide antibody deficiency.primary immunodeficiencyweak immune response10021460NL-OMON39742Interfacultaire Werkgroep Immuundeficiënties (WID)
Active, not recruiting
Phase 1
Pneumococcal vaccination in healthy adultsimmunodeficiencyEUCTR2019-001118-40-NLDepartment of Pulmonology210
Recruiting
Not Applicable
Response to pneumococcal polysaccharide vaccination in healthy adultsimmunodeficiencyNL-OMON55592Sint Antonius Ziekenhuis210