ARIVAC Trial: Effectiveness of an 11-valent pneumococcal conjugate vaccine against pneumonia in Philippine children

Background Information

Acute respiratory infections (ARI), particularly pneumonia, are the major cause of mortality in children under 5 years of age in developing countries. Bacteria cause the majority of pneumonia cases, and probably more than half of these cases are due to Streptococcus pneumoniae. A control program, which promotes the early diagnosis and treatment of pneumonia with antibiotics in young children, reduces pneumonia mortality. However, an increase in the prevalence of pneumococcal isolates resistant to antibiotics in several countries has prompted investigators to look into new pneumococcal conjugate vaccines to prevent pneumonia morbidity and mortality. This vaccine has recently been shown to increase immunity in young children who are at high risk of getting pneumonia and dying from the illness. It has also been found to be 100% efficacious against invasive pneumococcal disease.

A phase 3, randomized, double blind, controlled, clinical trial (RCT) of a pneumococcal conjugate vaccine to determine its efficacy in preventing x-ray proven pneumonia in young children is being conducted in 6 municipalities in the island of Bohol, Philippines. The trial commenced in July 2000 and will last until 2005.

This trial is designed to study the effectiveness of the vaccine in preventing radiologically verified childhood pneumonia in developing country conditions. Pneumonia was chosen as the primary endpoint diagnosis because of its importance as the major public health disease burden in children under five years old. The Philippines was chosen as a study site since long-term baseline studies on ARI case management and on the causes of pneumonia, sepsis and meningitis have been carried out on the island of Bohol, which also has a research friendly environment. This study is so far the only phase 111 study being planned with any pneumococcal vaccine to take place in Asia.

The project is registered with Current Controlled Trials, reference ISRCTN62323832.

The trial is a joint venture of the ARIVAC consortium.

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©2006 ARIVAC Consortium