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Clinical Trials/EUCTR2012-004486-41-SE
EUCTR2012-004486-41-SE
Active, not recruiting
Phase 1

Vaccination of antibody deficient patients with Prevenar13 - a comparative study between antibody response and cellular immunity. - PNEUMOCE

Karolinska University Hospital, Huddinge, Sweden0 sites20 target enrollmentDecember 11, 2012
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ConditionsPatients with IgG-deficiencyTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsPrevenar13

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with IgG-deficiency
Sponsor
Karolinska University Hospital, Huddinge, Sweden
Enrollment
20
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 11, 2012
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital, Huddinge, Sweden

Eligibility Criteria

Inclusion Criteria

  • •1\. The patients should have been diagnosed with IgG\-deficiency; IgG1\<2\.8 g/l and/or IgG2\<1\.15 g/L.
  • •2\. The patient should be between 18\-65 years of age
  • •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 20
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 20

Exclusion Criteria

  • •1\. The patient should not have been given Prevenar 7 or 13 prior to the study inclusion.
  • •2\. The patient should not have been given PPV23 2 years prior to the study inclusion.
  • •3\. The patient should not be pregnant.
  • •4\. The patient should not take part in any other clinical study involving drugs or vaccines.
  • •The healthy controls should be healthy and not be on any drugs that could interfere with an immune response (systemic steroids, NSAIDs, immunosuppressive drugs).

Outcomes

Primary Outcomes

Not specified

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