Phase 4 N=70 Randomized Prevention

Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00836641 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2013

Primary outcome: Primary: Immunogenicity of Pneumococcal Vaccination — 0.05; 0.05 [µg/ml]

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: prevenar (Biological); pneumovax (Biological)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Johann Wolfgang Goethe University Hospital
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunogenicity of Pneumococcal Vaccination	0.05; 0.05	—
SECONDARY Number of Vaccinees With Adverse Events	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

asthma classified according to the Global Initiative on Asthma (GINA) °1-2

Exclusion Criteria

antecedent pneumococcal immunization

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00836641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.