Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children

• ClinicalTrials.gov Identifier: NCT00580684
• Recruitment Status: Completed
• First Posted: December 27, 2007
• Last Update Posted: December 27, 2007
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: December 21, 2007
• First Posted Date: December 27, 2007
• Last Update Posted Date: December 27, 2007
• Study Start Date: September 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: December 21, 2007): To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: December 21, 2007): To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Vaccines, Pneumococcal
• Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

plain polisacaride vaccine 23 valent to reduce carriage

Study Arms

• Active Comparator: G1
  G1: prevenar
  Intervention: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
• Active Comparator: G2
  G2: pneumo 23
  Intervention: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 21, 2007): 101
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2004
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Healthy children between
• 2 to 9 years old.
• No history of antibiotic use prior 1 month of enrollment
• No history of invasive pneumococcal disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 9 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00580684
• Other Study ID Numbers: 0887X-101198
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: December 2007