Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children

Abstract

In a phase three randomized, double-blind, saline-placebo controlled study conducted in Bohol, Philippines, we assessed the reactogenicity of an 11-valent PCV (11PCV) when given simultaneously with EPI vaccines at 6, 10 and 14 weeks of age in a subset of 252 and 126 children who were followed-up by passive and active surveillance, respectively. In passive surveillance (parents' observation), redness was observed in 14.4% vs. 11.8%, swelling in 8% vs. 3.9%, induration in 13.6% vs. 8.6%, and pain in 54.4% vs. 47.2% of 11PCV and placebo infants, respectively, after the first dose of the vaccine. Redness at injection site was significantly more common with 11PCV than placebo infants after the third dose (13.6% vs. 3.2%, p=0.005). Crying (53.6% vs. 48%), irritability (48% vs. 46.4%), and fever (22.4% vs. 19.6%) were commonly observed in 11PCV and placebo infants, respectively, after the first dose. Loss of appetite was significantly more common among 11PCV (12%) than placebo (4.7%) infants but only after the first dose of the vaccine (P=0.04). The number of reactions decreased in both groups with subsequent doses. The non-adjuvanted 11PCV vaccine was found to be well-tolerated among Filipino infants.