Official Title: “Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage
  • plain polisacaride vaccine 23 valent to reduce carriage

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: G1
  • G1: prevenar
• Active Comparator: G2
  • G2: pneumo 23

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 9 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580684

Study ID Number: 0887X-101198

ClinicalTrials.gov Identifier: NCT00580684

Health Authority: Brazil: National Committee of Ethics in Research