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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00195611
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 29, 2010
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Condition or disease Intervention/treatment
Otitis Media Otitis Media With Effusion Pneumococcal Infections Drug: Prevenar

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Study Type : Observational
Actual Enrollment : 3293 participants
Time Perspective: Prospective
Official Title: Observational Study of the Rhinopharyngeal Carriage of Streptococcus Pneumoniae (Sp) in Infants With Acute Otitis Media (AOM)
Study Start Date : September 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Screening, Cross-Sectional, Defined Population, Prospective Study

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00195611

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Auch, France, 32000
Brest, France, 29200
Canne La Boca, France, 06150
Chalons En Champagne, France, 51000
Chambery, France, 73000
Combs La Ville, France, 77380
Creteil, France, 94000
Draguignan, France, 83300
Essey Les Nancy, France, 54270
Fontenay Sous Bois, France, 94120
Grenoble, France, 38000
Grigny, France, 91350
Lagny, France, 77400
Les Lilas, France, 93260
Les Ulis, France, 91940
Lyon, France, 96003
Marquette, France, 59520
Marseille, France, 13013
Massy, France, 91300
Molsheim, France, 67120
Paris, France, 75006
Paris, France, 75007
Paris, France, 75015
Paris, France, 75020
Paris, France, 75116
Rouen, France, 76000
Saint Brieuc, France, 22000
Saint Maur Des Fosses, France, 94100
Selestat, France, 67600
Thionville, France, 57100
Toulouse, France, 31000
Tours, France, 37000
Vandoeuvre Les Nancy, France, 54500
Vence, France, 06140
Villeneuve Les Avignon, France, 30400
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Layout table for additonal information Identifier: NCT00195611    
Other Study ID Numbers: 0887X-100918
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Middle Ear Infection
Additional relevant MeSH terms:
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Pneumococcal Infections
Otitis Media
Otitis Media with Effusion
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ear Diseases
Otorhinolaryngologic Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs