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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Vaccines, Pneumococcal; Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

Study type: Interventional

Funder types: Industry

Identifiers

NCT00580684

0887X-101198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

G1

Active Comparator group

Description:

G1: prevenar

Treatment:

Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage

G2

Active Comparator group

Description:

G2: pneumo 23

Treatment:

Biological: pneumococcus conjugate vaccine 7 valent to reduce carriage