ABSTRACT
The endpoint used for a phase 3 pneumococcal conjugate vaccine (PCV) trial in Bohol, Philippines was radiographic consolidation. Only one (Bohol Regional Hospital, BRH) of the four surveillance hospitals had a quality control/quality assurance program (QC/QA) prior to the trial. QC/QA was initiated in the three private hospitals. Radiologists from BRH evaluated radiographs from all hospitals based on recommended standards. Four thousand nine hundred and eighty nine films were analyzed. In 2000, the proportion of good quality films was 65% and 29% in BRH and private hospitals, respectively. By 2004, these increased to 92% and 79%, respectively. Poor film quality was commonly due to absence of collimation and poor contrast. The regular QC/QA implementation was necessary to improve film quality and was particularly important in our PCV trial that used X-ray proven consolidation as an endpoint.
Subject(s)
Pneumococcal Vaccines/therapeutic use , Pneumonia, Pneumococcal/diagnostic imaging , Radiology/standards , Child , Developing Countries , Humans , Philippines , Quality Assurance, Health Care/methods , Radiography , Radiology/methodsABSTRACT
We first studied the immunogenicity of PRP-T and DTwP vaccines in Filipino infants given at 6, 10 and 14 weeks concomitantly with either an aluminum adjuvanted eleven-valent pneumococcal conjugate vaccine (11PncTD) or a meningococcal diphtheria-conjugated vaccine as compared to a control group that received only DTwP/PRP-T. The GMCs and proportions of infants achieving protective antibody concentrations to DTwP and PRP-T vaccine antigens were similar among the groups. In the second phase, the control group received 11PncTD at 18 weeks and the antibody concentrations were measured at 9 months in all children; 11PncTD induced a booster response to diphtheria in the control group. There was no negative interference from concomitant administration of new conjugate vaccines. In contrast, 11PncTD can boost the antibody response to the carrier proteins.
