A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador Vacuna líquida combinada DTPw-HepB-Hib como dosis de refuerzo en infantes de El Salvador

• Main Authors: Eduardo Suárez, Edwin J. Asturias, Anne Katrin Hilbert, Christian Herzog, Ursula Aeberhard, Christian Spyr
• Format: Article in Journal/Newspaper
• Language: English; Spanish; Portuguese
• Published: Pan American Health Organization 2010
• Subjects: Vacunas; esquema de inmunización; vacunas contra la hepatitis B; vacunas contra Haemophilus; vacuna contra difteria; tétanos y tos ferina; lactante; El Salvador; Vaccines; immunization; methods; Hepatitis B vaccines; Haemophilus vaccines; Diphtheria-Tetanus-Pertussis vaccine; infant; Medicine; R; Arctic medicine. Tropical medicine; RC955-962; Public aspects of medicine; RA1-1270; Arctic
• Online Access: https://doaj.org/article/e8b0f31c38fa444ba43a9b67df78be6e

OBJECTIVES:To compare the safety and immunogenicity of a booster dose of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HepB-Hib) vaccine to the separate administration of commercially available DTPw and Hib vaccines in healthy toddlers. METHODS:An open-label, randomized, parallel-group, Phase III study conducted at six centers in San Salvador, El Salvador, during February-June 2006. Toddlers (15-24 months of age) were eligible to participate if they had received primary immunization at 2, 4, and 6 months of age with a commercial DTPw-HepB/Hib vaccine requiring reconstitution. Participants received either one booster dose of DTPw-HepB-Hib fully liquid vaccine or DTPw and Hib vaccines administered separately. Blood samples were taken immediately prior to and at 1 month post-vaccination. For a 5-day period following vaccination, solicited adverse events were collected in subject diaries and assessed. RESULTS:The combined DTPw-HepB-Hib fully liquid vaccine was non-inferior to the separately administered DTPw and Hib vaccines, in terms of seroprotection/seroconversion rates for all antigens evaluated. The combination vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. The geometric mean concentrations (GMCs) of all antibodies in the DTPw-HepB-Hib group exceeded the seroprotection/seroconversion thresholds by very large margins, although for some antigens they were somewhat lower than the corresponding titers in the comparator group. With the combination vaccine, considerably fewer solicited local and systemic adverse events, such as fever and irritability, were reported than with the comparator vaccines. CONCLUSIONS:This study demonstrates that the fully liquid combined DTPw-HepB-Hib vaccine is highly immunogenic and has a favorable safety profile when given as a booster vaccination to toddlers who have received a primary vaccination course with a different pentavalent vaccine that requires ...