title: 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.
authors.affiliation: Research Institute for Tropical Medicine (RITM), Muntinlupa City 1780, Philippines. ritmari@smartbro.net
authors.forename: Juanita
authors.initials: J
authors.lastname: Ugpo
authors.forename: Marilla
authors.initials: M
authors.lastname: Lucero
authors.forename: Gail
authors.initials: G
authors.lastname: Williams
authors.forename: Marites
authors.initials: M
authors.lastname: Lechago
authors.forename: Leilani
authors.initials: L
authors.lastname: Nillos
authors.forename: Veronica
authors.initials: V
authors.lastname: Tallo
authors.forename: Hanna
authors.initials: H
authors.lastname: Nohynek
mesh_terms: D022422:Diphtheria-Tetanus Vaccine / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D010679:Philippines; D010919:Placebos / Q000008:administration & dosage; D022242:Pneumococcal Vaccines / Q000009:adverse effects*; D017778:Vaccines, Combined / Q000009:adverse effects; D018074:Vaccines, Conjugate / Q000009:adverse effects
chemical_list: D022422:Diphtheria-Tetanus Vaccine; D010919:Placebos; D022242:Pneumococcal Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate