Study Evaluating the Nasopharyngeal Carriage in Healthy Children

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NCT00768833

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Study Location
Pfizer Investigational Site
Offenbach, , 63069, Germany
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-4 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Main inclusion criteria:

- Age at enrolment 3 to 4 month Main

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Malformation or injury of the nasopharynx


- Known or suspected immunodeficiency


- Relevant immunosuppression


- Use of antibiotics up to 10 days prior to study inclusion

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Nasopharyngeal Carriage in Healthy Children
Official Title Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany
Brief Summary The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community sample
Condition Healthy Subjects
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 20, 2014)		242
Original Estimated Enrollment
 (submitted: October 7, 2008)		240
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Main inclusion criteria:

  • Age at enrolment 3 to 4 month Main

Exclusion Criteria:

  • Malformation or injury of the nasopharynx
  • Known or suspected immunodeficiency
  • Relevant immunosuppression
  • Use of antibiotics up to 10 days prior to study inclusion
Sex/Gender
Sexes Eligible for Study:All
Ages 3 Months to 4 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00768833
Other Study ID Numbers 0887X1-4453
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2014