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| |  13-Valent Vaccine Expands Coverage Against Pneumococcal Disease, Safe With Routine Vaccination in Infants: Presented at ESPID BRUSSELS, Belgium -- June 16, 2009 -- Concomitant administration of a 13-valent or 7-valent pneumococcal vaccine (PCV13 and PCV7, respectively) with routine diphtheria tetanus and pertussis (DtaP), hepatitis B (HBV), polio (IPV), Haemophilus influenzae type B (Hib), and meningococcal C (MnCC) vaccines does not interfere with the response to concomitantly administered vaccine antigens and elicits a likely effective antipneumococcal immune response in infants and toddlers. Federico Martinon-Torres, MD, Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain, presented the study results on June 11 on behalf of the 3007 Study Group at the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). For the study, healthy infants were randomised to receive PCV13 (n = 315) or PCV7 (n = 304) with DTaP, HBV, and Hib vaccines at ages 2, 4, and 6 months and an MnCC vaccine at ages 2 and 4 months. Antibody response to selected antigens in both groups was assessed 1 month after doses 2 and 3 and 1 month after the toddler dose. Local and systemic events were reported for 4 days after vaccination. The results showed that infant immune responses to Mncc and DTaP vaccines were comparable in recipients concomitantly receiving the PCV13 or PCV7. Pneumococcal immune response was assessed based on the World Health Organisation guideline for determining effective antipneumococcal responses, and defined as the proportion of infants achieving a serotype-specific immunoglobulin G (IgG) antibody concentration of >=0.35 mcg/ml. After the second dose, >73% of infants responded with antipolysaccharide IgG concentrations of 0.35 mcg/ml, except for serotypes 6B (27.9%) and 23F (55.8%) contained in PCV13. However, after the third dose, the proportion of responders rose to 86% for all serotypes, and vaccine responses were increased compared with after the second dose for all serotypes except 19F. For serotype 19F, general mean concentrations were comparable after each dose. Parents and guardians used electronic diaries to monitor safety. Local reactions (redness, swelling, and tenderness at PCV injection site), systemic events (fever, decreased appetite, decreased sleep, increased sleep, and irritability), and use of antipyretics were similar, and mostly mild, in both groups. Three infants in the PCV13 group experienced severe adverse events (urinary tract infection, orchitis, pneumonia), as did 1 infant in the PCV7 group (gastroenteritis). All of these infants were hospitalised. None of the adverse events were considered related to vaccination. [Presentation title: Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Receiving Routine Vaccinations in Spain. Abstract P529]
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