Last updated date
ABOUT THIS STUDY
The purpose of this study is to estimate the local and systemic tolerability of Prevenar in
children ages 2 to 5 years old in usual care settings.
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
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
2-5 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- High-risk children ages 2 to 5 years old
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior administration of Prevenar
- Prior and/or concurrent administration of 23 vPs vaccine
NEED INFO?
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Study Evaluating Prevenar in High-Risk Children | ||||||
| Official Title | Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years | ||||||
| Brief Summary | The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Not Provided | ||||||
| Study Population | Not Provided | ||||||
| Condition | Pneumococcal Disease | ||||||
| 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 | ||||||
| Estimated Enrollment | 5000 | ||||||
| Original Enrollment | Same as current | ||||||
| Actual Study Completion Date | April 2007 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion criteria:
| ||||||
| Sex/Gender |
| ||||||
| Ages | 2 Years to 5 Years (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 | NCT00234338 | ||||||
| Other Study ID Numbers | 101850 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Not Provided | ||||||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
| ||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | December 2007 | ||||||