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.
Main inclusion criteria:
- Age at enrolment 3 to 4 month Main
- Malformation or injury of the nasopharynx
- Known or suspected immunodeficiency
- Relevant immunosuppression
- Use of antibiotics up to 10 days prior to study inclusion
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 242 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | August 2014 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
