Immune response to pneumococcal vaccination in patients after pneumonia

Conditions: Immune response to pneumococcal vaccination in patients after community acquired pneumonia with Streptococcus pneumoniae
MedDRA version: 16.0Level: LLTClassification code 10071915Term: Vaccination site bleedingSystem Organ Class: 100000004867
MedDRA version: 16.0Level: LLTClassification code 10046860Term: Vaccination adverse reactionSystem Organ Class: 100000004863
MedDRA version: 16.0Level: LLTClassification code 10059078Term: Vaccination related malaiseSystem Organ Class: 100000004863
MedDRA version: 16.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865
MedDRA version: 16.0Level: LLTClassification code 10069488Term: Vaccination site paresthesiaSystem Organ Class: 100000004867
MedDRA version: 16.0Level: LLTClassification code 10069630Term: Vaccination site edemaSystem Organ Class: 100000004867
MedDRA version: 16.0Level: LLTClassification code 10069485Term: Vaccination site stingingSystem Organ Class: 100000004867
MedDRA version: 16.0Level: LLTClassification code 10069631Term: Vaccination site tendernessSystem Organ Class: 100000004867
MedDRA version: 16.0Level: LLTClassification code 10069473Term: Vaccination site hematomaSystem Organ Class: 100000004867

Registration Number: EUCTR2013-002166-39-NL

Lead Sponsor: Sint Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients who participated in the Ovidius or Triple-P study (2004-2009).
2. Diagnosis in these studies with pneumococcal pneumonia or pneumonia due other identified organism.
3. Age = 18 years.
4. Signing of informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Diagnosis of pneumonia without an identified causative organism.
2. Fever at time of vaccination.
3. Previous/known allergic reaction to any of the components of the vaccine given.
4. Mentally incompetent.
5. Previous pneumococcal vaccination*

* with exception of patients displaying a persistent defect in the serotype specific immune response after vaccination with the polysaccharide-based vaccine Pneumovax 23. Possibly this specific serotype defect will be ‘’repaired’’ after vaccination with the (more potent) conjugate vaccine Prevnar 13.