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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00836641
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : September 2, 2013
Last Update Posted : September 2, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Asthma Biological: prevenar Biological: pneumovax Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Primary Completion Date : October 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Immunogenicity of Pneumococcal Vaccination [ Time Frame: 12 months ]
    we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).


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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836641


Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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
First Posted: February 4, 2009    Key Record Dates
Results First Posted: September 2, 2013
Last Update Posted: September 2, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs