Trial document




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  DRKS00008210

Trial Description

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Title

Utilization of pediatric combination vaccines and reasons for non-compliance

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Trial Acronym

STIKKids

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This so-called non-interventional study (Anwendungsbeobachtung) looks at vaccinations against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b and hepatitis B. According to the schedule recommended by STIKO a vaccine should be given at the age of 2, 3, 4 and 11-14 months. Children can be vaccinated with a hexavalent vaccine against 6 diseases (diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenza type b, and hepatitis B). Alternatively, a pentavalent vaccine against 5 diseases (diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b) can be given alone or in combination with a monovalent hepatitis B vaccine. In this study the compliance with STIKO recommendations will be evaluated with regard to the paediatric pentavalent and hexavalent vaccines described above.

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Brief Summary in Scientific Language

Part 1: Prospective observational study
Part 2: Retrospective secondary data collection
This multi-center study investigates the compliance with STIKO recommendations with regard to pediatric vaccinations against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenza type b, and hepatitis B by evaluating the choice of vaccine in daily praxis and the time point of vaccine administration.

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Organizational Data

  •   DRKS00008210
  •   2015/05/07
  •   [---]*
  •   no
  •   Approved
  •   F-2015-014, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   Study on pentavalent and hexavalent pediatric vaccines
  •   Z23.6 -  Need for immunization against diphtheria alone
  •   Z23.5 -  Need for immunization against tetanus alone
  •   Z23.7 -  Need for immunization against pertussis alone
  •   Z23.8 -  Need for immunization against other single bacterial diseases
  •   Z24.0 -  Need for immunization against poliomyelitis
  •   Z24.6 -  Need for immunization against viral hepatitis
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Interventions/Observational Groups

  •   Data will be collected using standardized paper questionnaires completed by the investigator after each vaccination including information on the type of vaccine, date of vaccination and co-administration of other vaccines.
    For the prospective study part parents will be asked to complete a questionnaire including information on their decision for a against a vaccination of their child and reasons for delayed vaccinations.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Prospective study part:
To investigate the compliance with current STIKO recommendations by evaluating the
• Choice of vaccine (i.e. administration of pentavalent vs. hexavalent vaccine or pentavalent plus administration of monovalent hepatitis B vaccine) in the daily practice and the time point of vaccine administration

Retrospective study part:
To investigate the compliance with STIKO recommendations of 2012-2015 by evaluating the
• Choice of vaccine (i.e. administration of pentavalent vs. hexavalent vaccine or pentavalent plus administration of monovalent hepatitis B vaccine) in the daily practice and the time point of vaccine administration

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Secondary Outcome

Prospective study part:
• To assess the co-administration of other vaccines
• To examine compliance aspects stratified by gender of the investigator, age of parents, rural vs. urban areas, regions of Association of Statutory Health Insurance Physicians (ASHIP), and socio-demographic groups
• To evaluate reasons for non-given vaccinations and for deviations from the recommended vaccination schedule


Retrospective study part:
• To assess the co-administration of other vaccines To compare all compliance aspects with those of the prospective study part

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2015/05/29
  •   3680
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Weeks
  •   36   Months
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Additional Inclusion Criteria

Prospective Study Part
1. Informed consent on data processing for study purposes signed by both parents (in case one parent is entitled for custody solely ICF signed by one parent is sufficient)
2. Children from six weeks of age

Retrospective Study Part
1. Informed consent on data processing for study purposes signed by both parents (in case one parent is entitled for custody solely ICF signed by one parent is sufficient)
2. Children 24-36 months of age

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Exclusion Criteria

Prospective Study Part
1. Children who have received more than one previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenza type b

Retrospective Study Part
1. Children younger than 24 months of age and older than 36 months of age

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Addresses

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    • Sanofi Pasteur MSD GmbH
    • Alexanderufer 3
    • 10117  Berlin
    • Germany
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    • Sanofi Pasteur MSD GmbH
    • Mr.  Dr.  Thorsten  Reuter 
    • Alexanderufer 3
    • 10117  Berlin
    • Germany
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    • Sanofi Pasteur MSD GmbH
    • Mr.  Dr.  Thorsten  Reuter 
    • Alexanderufer 3
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi Pasteur MSD GmbH
    • Alexanderufer 3
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2015/09/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.