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NCT00580684 Clinical Trial

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

Vaccines, Pneumococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00580684
Other study ID # 0887X-101198
Secondary ID
Status Completed
Phase Phase 4
First received December 21, 2007
Last updated December 21, 2007
Start date September 2003
Est. completion date August 2004

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 9 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. 12 months No
Secondary To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage. 12 months No
See also
  Status Clinical Trial Phase
Completed NCT00373958 - Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00366678 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00366340 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
Completed NCT00366899 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00368966 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. Phase 3
Completed NCT00384059 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00366548 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants Phase 3
Completed NCT00444457 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants Phase 3
Completed NCT00294294 - Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa Phase 4
Completed NCT00708682 - Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico Phase 3
Completed NCT00474539 - Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Phase 3
Completed NCT01086397 - Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia N/A