Nasopharyngeal Carriage of S. Pneumoniae
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne
About this trial
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.
Eligibility criteria
Qualifiers
both sexes
suffering from suppurative AOM or healthy children
age: 6 months to 36 months for AOM
age: 6 months to 15 years for healthy children
Disqualifiers
severe underlying disease,
inclusion in the study during the previous 12 months
Children with bullous myringitis cannot be included.
Trial design
Treatments tested in this trial
- nasopharyngeal sample (mandatory)
- Stools collection or anorectal swab samples (optional)
- nasopharyngeal sample (optional)
Treatment groups
25,760 Participants
are divided into 3 treatment groupsSponsors and collaborators
Association Clinique Thérapeutique Infantile du val de Marne
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov