Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
PAPSI
Prospective Randomized Controlled Phase 4 Study on the Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
Asthma is a major health problem in preschool children. Infections by pneumococci a the most frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination against pneumococci is recommended by scientific boards and the medical community, in order to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal immunization in preschool asthmatics are scarce.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Oct 2006
Typical duration for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedResults Posted
Study results publicly available
September 2, 2013
CompletedSeptember 2, 2013
July 1, 2013
2 years
February 3, 2009
April 4, 2013
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity of Pneumococcal Vaccination
we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (\>0.35 µg/ml).
12 months
Secondary Outcomes (1)
Number of Vaccinees With Adverse Events
12 months
Study Arms (2)
pneumococcal immunization (2 mo)
ACTIVE COMPARATORone dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
pneumococcal immunization (10 mo)
ACTIVE COMPARATORone dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
Interventions
7-valent pneumococcal conjugate vaccine
23 valent pneumococcal polysaccharide vaccine
Eligibility Criteria
You may qualify if:
- asthma classified according to the Global Initiative on Asthma (GINA) °1-2
You may not qualify if:
- antecedent pneumococcal immunization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rose MA, Schubert R, Kujumdshiev S, Kitz R, Zielen S. Immunoglobulins and immunogenicity of pneumococcal vaccination in preschool asthma. Int J Clin Pract. 2006 Nov;60(11):1425-31. doi: 10.1111/j.1742-1241.2006.01093.x.
PMID: 17073839BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Markus Rose
- Organization
- Goethe University Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zielen, M.D.
Goethe University Childrens Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Paediatrics
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
October 1, 2006
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
September 2, 2013
Results First Posted
September 2, 2013
Record last verified: 2013-07