[Research activity on pediatric vaccines in Spain: descriptive analysis of prospective studies published between 1990...

To describe the overall characteristics of prospective studies on vaccines in children, performed by Spanish investigators and published between 1990 and 1998.

Through a bibliographic research on MEDLINE and EMBASE, 24 prospective studies, performed in Spain, published as original papers, and with objectives directly related to the administration of vaccines to children have been identified. These studies were grouped as: clinical trials (group A), studies performed on established vaccination programmes (group B), and those that could not be included in the above mentioned groups (group C).

5, 9 and 10 studies belonged to groups A, B and C, respectively. More than 12,800 subjects participated in these studies, belonging to both normal population or specific risk groups. In 11 studies, the study population comprised newborns and infants. The vaccines under investigation were: hepatitis B (10 studies), DTPe/Pa (6), MMR (3), flu (2), Hib (1), hepatitis A (1), and meningococcus A and C (1) to address different objectives (in most of them, immunogenicity and/or reactogenicity). Nine had external financial support; 21 were performed by hospital and/or primary care investigators, and 18 in the Vasque Coutry, Madrid or Valencia. 13 publications reported obtaining informed consent, and 8 on the approval of the study protocol by an independent committee. Ten studies were published by international journals.

This study shows that most of the studies are conducted by clinicians, with vaccines targetted to newborns and infants, with no external financial support, in a small number of autonomous communities, and usually published in Spanish Journals. The submission of this type of studies to a research ethics committee is desirable, something done to a lesser extent than obtaining informed consent.