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Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

NCT ID: NCT00836641

Last Updated: 2013-09-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Keywords

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preschool asthma sequential pneumococcal immunization immunogenicity safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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pneumococcal immunization (2 mo)

one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)

Group Type ACTIVE_COMPARATOR

prevenar

Intervention Type BIOLOGICAL

7-valent pneumococcal conjugate vaccine

pneumovax

Intervention Type BIOLOGICAL

23 valent pneumococcal polysaccharide vaccine

pneumococcal immunization (10 mo)

one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)

Group Type ACTIVE_COMPARATOR

prevenar

Intervention Type BIOLOGICAL

7-valent pneumococcal conjugate vaccine

pneumovax

Intervention Type BIOLOGICAL

23 valent pneumococcal polysaccharide vaccine

Interventions

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prevenar

7-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

pneumovax

23 valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevnar, PCV-7 pneumopur, PPV-23

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* antecedent pneumococcal immunization
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Markus Rose

Professor of Paediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Zielen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Goethe University Childrens Hospital

References

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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.

Reference Type BACKGROUND
PMID: 17073839 (View on PubMed)

Other Identifiers

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PAPSI.FFM.3217

Identifier Type: -

Identifier Source: org_study_id