asopharyngeal pneumococcal colonization data in infants at the age of 12, 18 and 24 months - Pneumococcal carriage in infants
- Conditions
- Pneumococcal carriership in children having previously received Prevenar vaccination (7-valent pneumococcal conjugate vaccine) according to the 3+1 vaccination schedule used in the Dutch National Immunization Program (NIP).Comparison will be done to the 2+1 schedule group of the MINOES trial (ISRCNTN25571720).
- Registration Number
- EUCTR2008-000083-17-NL
- Lead Sponsor
- ederlands Vaccin Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
These criteria are derived from the related MINOES study, in order to increase comparability
•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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
These criteria are derived from the related MINOES study, in order to increase comparability
•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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method