Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
NCT00580684
Last updated date
ABOUT THIS STUDY
To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal
carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the
rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
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
Vaccines, Pneumococcal, Vaccines, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
2-9 years
Inclusion Criteria
Show details
- Healthy children between
- 2 to 9 years old.
- No history of antibiotic use prior 1 month of enrollment
- No history of invasive pneumococcal disease
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Vaccines, Pneumococcal, Vaccines, Pneumococcal Conjugate VaccineStudy Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
NCT00580684
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children | |||
Official Title ICMJE | Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children. | |||
Brief Summary | To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. | |||
Detailed Description | This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE |
| |||
Intervention ICMJE | Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
plain polisacaride vaccine 23 valent to reduce carriage | |||
Study Arms ICMJE |
| |||
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 ICMJE | Completed | |||
Actual Enrollment ICMJE | 101 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years to 9 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00580684 | |||
Other Study ID Numbers ICMJE | 0887X-101198 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |