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Nasopharyngeal Carriage of S. Pneumoniae

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 1, 2024 to Dec 31, 2026v5 Show 8 more changesShow less
    • Primary endpoints: 1 to 6
    • Enrollment target: 23560 to 25760
    • Interventions: Stools collection or anorectal swab samples (Other), nasopharyngeal sample (Other) to Stools collection or anorectal swab samples (optional) (Other), nasopharyngeal sample (mandatory) (Other), nasopharyngeal sample (optional)…
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 4 to 3
    • Publications: 18 to 20
    • Study arms: 2 to 3
    • Study description expanded, about 1 word
  2. Primary and study completion dates: Sep 1, 2023 to Dec 1, 2024v4 Show 5 more changesShow less
    • Enrollment target: 25000 to 23560
    • Interventions: nasopharyngeal sample (Other) to Stools collection or anorectal swab samples (Other), nasopharyngeal sample (Other)
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 36 words
    • Study arms: 1 to 2
  3. Collaborators expanded, about 1 wordv3
  4. Secondary endpoints: details revised at 2 of 3 entriesv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04460313
Lead Sponsor Association Clinique Thérapeutique Infantile du val de Marne
Collaborators: Pfizer
Conditions
(from sponsor)		 Nasopharyngeal Carriage, Children, Only, Antibiotic Resistant Strain
Enrollment 25,760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov