title: The safety and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) booster vaccine in healthy Vietnamese children.
abstract: Despite effective infant immunization against pertussis, the disease continues to circulate due to waning immunity. Booster vaccinations against pertussis beyond infancy are widely recommended. In Vietnam, however, no recommendations for pertussis boosters beyond the second year of life exist. This open-label, single-centre study was designed to assess the safety of a single booster dose of reduced-antigen-content-diphtheria-tetanus-acellular-pertussis vaccine (dTpa) in 300 healthy Vietnamese children (mean age 7.9years), who had completed primary vaccination against diphtheria, tetanus and pertussis. Solicited symptoms were recorded for 4days and unsolicited and serious adverse events (SAEs) for 31days post-vaccination. Pain and fatigue were the most common solicited local and general symptoms in 35.0% and 14.0% of children, respectively. Grade 3 swelling occurred in 3 children; no large injection site reactions or SAEs were reported. The dTpa booster vaccine was well tolerated and this study supports its administration in school age Vietnamese children.
authors.affiliation: National Institute of Hygiene and Epidemiology, 1 Yersin, Hanoi 1000, Vietnam. Electronic address: ducanhnihe@hn.vnn.vn.
authors.forename: Dang Duc
authors.initials: DD
authors.lastname: Anh
authors.affiliation: GSK Pharmaceuticals India Ltd., Bangalore, India. Electronic address: girish.7.jayadeva@gsk.com.
authors.forename: Girish
authors.initials: G
authors.lastname: Jayadeva
authors.affiliation: GSK Pharmaceuticals India Ltd., Bangalore, India. Electronic address: sherine.o.kuriyakose@gsk.com.
authors.forename: Sherine
authors.initials: S
authors.lastname: Kuriyakose
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA. Electronic address: hhhlatt@hotmail.com.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D002648:Child; D004165:Diphtheria / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D008297:Male; D010146:Pain / Q000139:chemically induced; D013742:Tetanus / Q000517:prevention & control; D014744:Vietnam; D014917:Whooping Cough / Q000517:prevention & control
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines
keywords: Booster vaccination; Children; Reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine; Vietnam; dTpa