EUCTR2008-000083-17-NL
Active, not recruiting
Phase 1
asopharyngeal pneumococcal colonization data in infants at the age of 12, 18 and 24 months - Pneumococcal carriage in infants
ederlands Vaccin Instituut0 sitesMay 30, 2008
DrugsPrevenar
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ederlands Vaccin Instituut
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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