To find an effective primary prevention for a significant fraction of acute respiratory infections (ARI), especially of severe ARI and related severe disease in infants and children in developing countries.
* prepare, initiate, and carry out the first half of an effectiveness study with a new 11-valent pneumococcal conjugate vaccine (Pnc-c) using meningococcal A,C as control, and administered within the national immunization programme (EPI) on the island of Bohol, the Philippines
* assess safety and immunogenicity in both industrialized and developing country settings (Finland, Vietnam) of the 4-valent Pnc-c developed by the Dutch-Nordic consortium
Demonstrate the immunogenicity and safety of the suggested Pnc-c vaccines. The study, once completed, will provide evidence on the efficacy, effectiveness and cost-benefits and establish serological correlates for protection of the 11-valent Pnc-c. The results will be directly and immediately applicable to countries of the South East Asian region, and more widely to developing countries with a moderate infant mortality rate of 40-60 / 1000. In addition, these studies will strengthen the skills of collaborating researchers in both developing and developed countries to perform small and large scale vaccine trials according to the GCP requirements.
The preparatory activities to pave the way for the effectiveness trial include:
* enrolling infants of the target populations at 6 weeks of age in primary health centers to a randomised, controlled, blinded immunogenicity and safety studies of the Pnc-c
* piloting the crucial EPI activities, randomization and record linkage procedures; upgrading the infrastructure and skills of personnel to meet the standards of Good Clinical Practice (GCP) at the study sites
* setting up vaccinovigilance activities to evaluate the short and long term safety of the study vaccines
* maintaining and setting up surveillance activities and clinical skills to detect cases for the primary endpoint, i.e. pneumonia and severe pneumonia in children 4 to < 23 moths of age both in hospitals and in primary health care settings
* identifying all Pnc pneumonia cases both by standard culture and alternative methods, i.e. antigen detection, and measurement of pneumolysin immune complexes
* within the effectiveness study, follow up a nested cohort of infants for the impact of the Pncc on the upper respiratory tract carriage of Pnc, for establishing serological correlates for protection, and for immunogenicity of the vaccine
* identifying unit costs to measure the cost benefit of the Pnc-c
* establishing monitoring activities to comply with the GCP and ICH guidelines.
Funding SchemeCSC - Cost-sharing contracts
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