Addressing the needs and gaps in safety assessment of vaccines during clinical trials in resource limited countries

Vaccine

Volumn 29, Issue 24, 2011, Pages 4173-4174

  Kisser, Agnes ^a   Heininger, Ulrich ^b   Moorthy, Vasee S ^c   Akanmori, Bartholomew D ^d   Leroy, Odile ^a  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

^d WHO REGIONAL OFFICE FOR AFRICA   (Congo)

Author keywords

Clinical trials; Poverty related diseases; Safety

Indexed keywords

VACCINE;

ARTICLE; CLINICAL ASSESSMENT; CLINICAL FEATURE; CLINICAL TRIAL (TOPIC); DRUG SAFETY; HUMAN; IMMUNIZATION; POVERTY; PRIORITY JOURNAL; RISK ASSESSMENT;

CLINICAL TRIALS AS TOPIC; DEVELOPING COUNTRIES; HUMANS; VACCINES;

EID: 79956129463     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.03.008     Document Type: Article

References (4)

1. Bonhoeffer J., Zumbrunn B., Heininger U. Reporting of vaccine safety data in publications: systematic review. Pharmacoepidemiol Drug Saf 2005, 14:101-106.
2. Bonhoeffer J., Kohl K., Chen R., Duclos P., Heijbel H., Heininger U., et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine 2002, 21:298-302.
3. Bonhoeffer J., Bentsi-Enchill A., Chen R.T., Fisher M.C., Gold M.S., Hartman K., et al. The Brighton Collaboration Methods Working Group: guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies. Vaccine 2009, 27:2282-2288.
4. European Vaccine Initiative. Report of the EC/EMVI/WHO EURHAVAC Workshop Safety Harmonisation in Pre-Licensure Clinical Trials, Brussels, 21st-22nd October 2008. Available at (accessed 24 November 2010); 2008. http://www.euvaccine.eu/sites/default/files/uploads/docs/Projects/EURHAVAC_Brussels_Workshop_Report_090713.pdf.