Effects of Routine Infant Vaccination With the 7-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization with Streptococcus pneumoniae in Children and Parents in the Netherlands
- Conditions
- asymptomatic pneumococcal nasopharyngeal colonisationpneumococcal carriage10004018
- Registration Number
- NL-OMON32500
- Lead Sponsor
- ederlands Vaccin Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 990
These criteria are derived from the related MINOES study, in order to increase comparability with historical unvaccinated controls
- The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
-They have to be willing and able to participate in the trial according to procedure
-Presence of a signed informed consent (the parents/legally representatives have
given written informed consent after receiving oral and written information)
-The children have received the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
Parents
-Parents are included when the 24-month-old children fulfil inclusion criteria
These criteria are derived from the related MINOES study with PCV-7 unvaccinated children
•Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule
•Previous vaccinations with other pneumoccocal vaccines
•Previous vaccinations of older brother(s) and/or sister(s) and/or parents with a pneumococcal conjugate vaccine (e.g. brother(s) and/or sister(s) that participated in the MINOES trial)
•Chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates.
-Coagulation disorder/medication;Parents are excluded
•when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of vaccine and nonvaccine-serotypes found in the nasopharyngeal<br /><br>swabs at 11 and 24 months of age </p><br>
- Secondary Outcome Measures
Name Time Method <p>The percentage of vaccine and nonvaccine-serotypes found in the nasopharyngeal<br /><br>swabs from the parents of the 24-month-old children<br /><br><br /><br>The percentage of children and parents positive for S. aureus, H. influenzae or<br /><br>M. catarrhalis </p><br>