Pneumococcal vaccination in healthy adults

Phase 1

• Conditions: immunodeficiency; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001118-40-NL
• Lead Sponsor: Department of Pulmonology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

•Age =18 years and =80 years
•Fits within pre-specified age and gender stratification blocks
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Previous vaccination with pneumococcal polysaccharide or conjugate vaccination
•Chronic disease that requires the use of immunosuppressive agents
•Known or highly suspected primary or secondary immunodeficiency
•Pregnancy
•Fever or active infection
•History of allergic reaction to one of the vaccine components
•No informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To develop new criteria for the interpretation of the IgG response to pneumococcal polysaccharide vaccination using serotype-specific normal values.;<br> Secondary Objective: To develop new criteria for the interpretation of the IgG1, IgG2, IgM and IgA response to pneumococcal polysaccharide vaccination using serotype-specific normal values.<br> To study the effect of age and gender on the response to pneumococcal polysaccharide vaccination in healthy adults.<br> ;Primary end point(s): Distribution of serotype-specific IgG antibody titers to 13 pneumococcal serotypes.;Timepoint(s) of evaluation of this end point: Four weeks after vaccination.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Distribution of serotype-specific IgG antibody titers to 13 pneumococcal serotypes eight weeks after vaccination.<br> Distribution of serotype-specific IgG1, IgG2, IgM and IgA antibody titers to 13 pneumococcal serotypes four and eight weeks after vaccination.<br> Distribution of serotype-specific percent change in IgG, IgG1, IgG2, IgM and IgA antibody titers to 13 pneumococcal serotypes four and eight weeks after vaccination in comparison to pre-vaccination.<br> ;Timepoint(s) of evaluation of this end point: Four and eight weeks after vaccination.