Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics (PAPSI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Rose, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00836641
First received: February 3, 2009
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Biological: prevenar
Biological: pneumovax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Phase 4 Study on the Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Immunogenicity of Pneumococcal Vaccination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).


Secondary Outcome Measures:
  • Number of Vaccinees With Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.


Enrollment: 70
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pneumococcal immunization (2 mo)
one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
Biological: prevenar
7-valent pneumococcal conjugate vaccine
Other Name: Prevnar, PCV-7
Biological: pneumovax
23 valent pneumococcal polysaccharide vaccine
Other Name: pneumopur, PPV-23
Active Comparator: pneumococcal immunization (10 mo)
one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
Biological: prevenar
7-valent pneumococcal conjugate vaccine
Other Name: Prevnar, PCV-7
Biological: pneumovax
23 valent pneumococcal polysaccharide vaccine
Other Name: pneumopur, PPV-23

Detailed Description:

Respiratory infections are major triggers of exacerbations in preschool asthma. Many countries' guidelines recommend immunization against pneumococci for patients suffering from chronic airway disease. Also the interval between priming and booster is a matter of debate.

We immunize a large group of preschool asthmatics (2-5 years old) sequentially: one dose of seven-valent pneumococcal conjugate vaccine (PCV-7) followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (PPV-23). We randomly assign half of the vaccinees to receive PPV-23 eight weeks after PCV-7 (group A), and the rest to a 10-month interval (group B). Pneumococcal antibody concentrations to serotype 4, 5, 6B, 7, 9V, 14, 18c, 19F, and 23F are determined initially, after two, and 12 months after PCV-7. Local and systemic reactions to each vaccine are recorded.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • antecedent pneumococcal immunization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836641

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, M.D. Goethe University Childrens Hospital
  More Information

Publications:
Responsible Party: Markus Rose, Professor of Paediatrics, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00836641     History of Changes
Other Study ID Numbers: PAPSI.FFM.3217
Study First Received: February 3, 2009
Results First Received: April 4, 2013
Last Updated: July 30, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:
preschool asthma
sequential pneumococcal immunization
immunogenicity
safety

ClinicalTrials.gov processed this record on September 18, 2014