There is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this risk. Four population-based surveillance sites in Kenya (total annual birth cohort of 11,500 infants) were used to conduct a 2-year post-introduction vaccine safety study of PCV10. Injection-site abscesses occurring within 7 days following vaccine administration were clinically diagnosed in all study sites (passive facility-based surveillance) and, also, detected by caregiver-reported symptoms of swelling plus discharge in two sites (active household-based surveillance). Abscess risk was expressed as the number of abscesses per 100,000 injections and was compared for the second vs first vial dose of PCV10 and for PCV10 vs pentavalent vaccine (comparator). A total of 58,288 PCV10 injections were recorded, including 24,054 and 19,702 identified as first and second vial doses, respectively (14,532 unknown vial dose). The risk ratio for abscess following injection with the second (41 per 100,000) vs first (33 per 100,000) vial dose of PCV10 was 1.22 (95% confidence interval [CI] 0.37-4.06). The comparator vaccine was changed from a 2-dose to 10-dose presentation midway through the study. The matched odds ratios for abscess following PCV10 were 1.00 (95% CI 0.12-8.56) and 0.27 (95% CI 0.14-0.54) when compared to the 2-dose and 10-dose pentavalent vaccine presentations, respectively. In Kenya immunization with PCV10 was not associated with an increased risk of injection site abscess, providing confidence that the vaccine may be safely used in Africa. The relatively higher risk of abscess following the 10-dose presentation of pentavalent vaccine merits further study.

OBJECTIVE: The objective of the study was to describe prenatal screening, positive test rates, and the administration of indicated interventions for hepatitis B, rubella, syphilis, group B streptococcus (GBS), chlamydia, and gonorrhea in the United States using 2 population-based surveys. STUDY DESIGN: Both surveys abstracted demographic, prenatal, and delivery data from a representative sample of delivering women in 10 states. Analyses accounted for the complex sampling design. RESULTS: Among the 7691 and 19,791 women in the 2 studies, screened proportions before delivery were more than 90% for hepatitis B and rubella, 80% for syphilis, 72-85% for GBS, and less than 80% for chlamydia and gonorrhea. Inadequate prenatal care was the strongest factor associated with no screening. Administration of interventions indicated by positive test results was variable but generally low. CONCLUSION: Improved prenatal screening and administration of indicated treatments or interventions, particularly for syphilis, GBS, chlamydia, and gonorrhea, will further protect newborns from infection.

OBJECTIVE: To estimate compliance with the 2002 revised perinatal group B streptococci (GBS) prevention guidelines in Tennessee, which recommend universal GBS screening of pregnant women at 35-37 weeks of gestation and, when indicated, administration of intrapartum chemoprophylaxis. METHODS: Active Bacterial Core surveillance conducts active, population-based surveillance for invasive GBS disease in 11 Tennessee counties. A retrospective case-cohort study was conducted using a stratified random sample of all live births in surveillance hospitals during 2003-2004, including all early-onset GBS cases. Factors associated with GBS screening and lack of optimal GBS chemoprophylaxis were analyzed using logistic regression. RESULTS: Screening was performed for 84.7% of pregnant women, but 26.3% of prenatal tests with documented test dates were performed before 35 weeks of gestation. Among women with an indication for GBS prophylaxis, 61.2% received optimal chemoprophylaxis, defined as initiation of a recommended antibiotic 4 hours or more before delivery. When the analysis was restricted to women who were admitted 4 hours or more before delivery, 70.9% received optimal chemoprophylaxis. Women not receiving optimal chemoprophylaxis were more likely to have penicillin allergy (11.7% compared with 2.5%, adjusted odds ratio [OR] 8.58, 95% confidence interval [CI] 1.57-47.04) or preterm delivery (45.5% compared with 13.2%, adjusted OR 5.52, 95% CI 2.29-13.30) and were less likely to have received the recommended prenatal serologic testing for other infectious diseases (77.9% compared with 91.1%, adjusted OR 0.30, 95% CI 0.09-0.98). Forty cases of early-onset GBS were identified (0.36 per 1,000 live births); 25% of these neonates were born to women who received screening at 35 weeks of gestation or later and, when indicated, optimal chemoprophylaxis. CONCLUSION: Universal prenatal GBS screening was implemented widely in Tennessee, although the timing of screening and administration of chemoprophylaxis often were not optimal. A substantial burden of early-onset GBS disease occurs despite optimal prenatal screening and chemoprophylaxis, suggesting that alternative strategies, such as vaccination, are needed. LEVEL OF EVIDENCE: II.