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NCT00195611 Clinical Trial

Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

Pneumococcal Infections Clinical Trial

Official title:
Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195611
Other study ID # 0887X-100918
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated June 27, 2010
Start date September 2005
Est. completion date June 2006

Study information
Verified date June 2010
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life Sciences
Study type Observational

Clinical Trial Summary

The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.

Recruitment information / eligibility
Status Completed
Enrollment 3293
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 24 Months
Eligibility Inclusion Criteria:

- Infants aged from 6 to 24 months

- Presenting with AOM (ear infection)

- Patients must not have received any antibiotic therapy within the past 7 days.

Other inclusion applies.

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Prevenar

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

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