Study on pentavalent and hexavalent pediatric vaccines Z23.6 Z23.5 Z23.7 Z23.8 Z24.0 Z24.6
Conditions
Interventions
Group 1: 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-ad
Sponsors
Sanofi Pasteur MSD GmbH
Eligibility
Sex/Gender
All
Age
6 Weeks to 36 Months
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactThorsten Reuter
Sanofi Pasteur MSD GmbH
Outcome results
None listed