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Field studies of pneumococcal conjugate vaccines to prevent ari in South East Asia - effectiveness of an 11-valent vaccine; safety and immunogenicityof a 4-valent vaccine under development

Objective

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.

Specifically to:
* 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
Expected Outcome

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 Scheme

CSC - Cost-sharing contracts

Coordinator

NATIONAL PUBLIC HEALTH INSTITUTE
Address
166,Mannerheimintie 166
00300 Helsinki
Finland

Participants (6)

First Pediatric Hospital of Ho Chi Minh City
Vietnam
Address
2,Su Van Hanh Street
70000 Ho Chi Minh City
Pasteur Mérieux Sérums and Vaccins
France
Address
3,Avenue Pasteur
92430 Marnes-la-coquette
RESEARCH INSTITUTE FOR TROPICAL MEDICINE
Philippines
Address
Filinvest Corporate City
1770 Muntinlupa City
Rigshospitalet København
Denmark
Address
9,Blegdamsvej
2100 København Ø
Rijksinstituut voor Volksgezondheid en Milieuhygiëne
Netherlands
Address
9,Antonie Van Leeuwenhoeklaan
3720 BA Bilthoven
Statens Serum Institut
Denmark
Address
5,Artillerivej
2300 København