Health Trials

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 groups

Locations

1
ACTIV Créteil France

Sponsors and collaborators

Association Clinique Thérapeutique Infantile du val de Marne

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov