NCT00195611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

September 13, 2005

Last Update Submit

June 27, 2010

Conditions

Keywords

Middle Ear Infection

Interventions

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Screening, Cross-Sectional, Defined Population, Prospective Study

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Unknown Facility

Auch, 32000, France

Location

Unknown Facility

Brest, 29200, France

Location

Unknown Facility

Canne La Boca, 06150, France

Location

Unknown Facility

Chambéry, 73000, France

Location

Unknown Facility

Châlons-en-Champagne, 51000, France

Location

Unknown Facility

Combs-la-Ville, 77380, France

Location

Unknown Facility

Créteil, 94000, France

Location

Unknown Facility

Draguignan, 83300, France

Location

Unknown Facility

Essey-lès-Nancy, 54270, France

Location

Unknown Facility

Fontenay-sous-Bois, 94120, France

Location

Unknown Facility

Grenoble, 38000, France

Location

Unknown Facility

Grigny, 91350, France

Location

Unknown Facility

Lagny, 77400, France

Location

Unknown Facility

Les Lilas, 93260, France

Location

Unknown Facility

Les Ulis, 91940, France

Location

Unknown Facility

Lyon, 96003, France

Location

Unknown Facility

Marquette-lez-Lille, 59520, France

Location

Unknown Facility

Marseille, 13013, France

Location

Unknown Facility

Massy, 91300, France

Location

Unknown Facility

Molsheim, 67120, France

Location

Unknown Facility

Paris, 75006, France

Location

Unknown Facility

Paris, 75007, France

Location

Unknown Facility

Paris, 75015, France

Location

Unknown Facility

Paris, 75020, France

Location

Unknown Facility

Paris, 75116, France

Location

Unknown Facility

Rouen, 76000, France

Location

Unknown Facility

Saint-Brieuc, 22000, France

Location

Unknown Facility

Saint-Maur-des-Fossés, 94100, France

Location

Unknown Facility

Sélestat, 67600, France

Location

Unknown Facility

Thionville, 57100, France

Location

Unknown Facility

Toulouse, 31000, France

Location

Unknown Facility

Tours, 37000, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54500, France

Location

Unknown Facility

Vence, 06140, France

Location

Unknown Facility

Villeneuve-lès-Avignon, 30400, France

Location

MeSH Terms

Conditions

Otitis MediaOtitis Media with EffusionPneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations