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OpenTrials
Completed

NCT Number: NCT00580684

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

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Key information

Conditions

Vaccines, Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumococcus conjugate vaccine 7 valent to reduce carriage

Biological

plain polisacaride vaccine 23 valent to reduce carriage

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Dec 27, 2007
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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