Children Who Received PCV-10 Vaccine from a Two-Dose Vial without Preservative Are Not More Likely to Develop Injection Site Abscess Compared with Those Who Received Pentavalent (DPT-HepB-Hib) Vaccine: A Longitudinal Multi-Site Study

BACKGROUND The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. OBJECTIVE To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. METHODS A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. RESULTS A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091). CONCLUSION No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.