Concomitant administration of a fully liquid,ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants |
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| Institution: | 1. Vaccine Research Center, FM3/Biokatu 10, 33014 University of Tampere, Tampere, Finland;2. Vaccine Evaluation Unit, Public Health England, Clinical Sciences Building 2, Manchester Royal Infirmary, Manchester, UK;3. Sanofi Pasteur Inc., Global Clinical Immunology, Discovery Drive, Swiftwater, PA, USA;4. Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France;1. Ministry of Health, Riyadh, Saudi Arabia;2. Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK;3. Sanofi Pasteur, Marcy l’Etoile, France;4. Sanofi Pasteur, Lyon, France;5. University of Manchester, Inflammation Sciences Research Group, School of Translational Medicine, Stopford Building, Manchester, UK;1. Kentucky Pediatric and Adult Research, Bardstown, KY, USA;2. J. Lewis Research Inc., Salt Lake City, UT, USA;3. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA;4. Novartis Pharma BV, Amsterdam, The Netherlands;1. Instituto de Atención Pediatrica, Apdo 607–1150 La Uruca, San Jose, Costa Rica;2. Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States;3. Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica;4. Centro de Investigaciones en Pediatría, Guatemala City, Guatemala;5. Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan;6. Department of Pediatrics, Chang Gung Children''s Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan;7. Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru;8. Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama;9. Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States;1. Centre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands;2. Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands;3. Department of Medical Microbiology and Infection Control, VU University Medical Center, The Netherlands;1. Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States;2. Clinic of Children''s Infectious Diseases, ?ernopolní 212/9, 662 63 Brno, Czech Republic;3. Department of Infectious Diseases, University Hospital, Charles University in Prague, Sokolska 581, 500 05 Hradec Kralove, Czech Republic;4. Department of Medicine, Duke University School of Medicine, Durham, NC 27703, United States;5. GSK, 5, Embassy Links, SRT Road, Opp to Accenture, Cunningham Road, Vasanth Nagar, Bangalore, Karnataka 560052, India;6. GSK, 14200 Shady Grove Road, Rockville, MD 20850, United States;7. Chiltern International for GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium;8. GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium;1. Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina;2. Centro de Estudios en Infectologia Pediátrica (CEIP), Cali, Colombia;3. Fundación Centro de Estudios Infectológicos (FUNCEI), French 3085 (C1425AWK), Buenos Aires, Argentina;4. Novartis Vaccines Clinical Research, Córdoba, Argentina;5. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA |
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| Abstract: | DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants.This was a phase III, open-label, randomised, multicentre study conducted in Finland. Healthy infants, aged 46–74 days (n = 350), were randomised in a ratio of 1:1 to receive DTaP-IPV-HB-PRP-T vaccine at two, three and four months, either with a MenC vaccine co-administered at two and four months (Group 1; n = 175) or without MenC vaccine (Group 2; n = 175). All infants also received routine rotavirus and 13-valent pneumococcal conjugate vaccines.The proportion of participants with an anti-HBs concentration ?10 mIU/mL assessed one month after the third dose of DTaP-IPV-HB-PRP-T vaccine was 97.5% 95%CI: 93.1–99.3] in the coadministration group and 96.1% 95%CI: 91.8–98.6] in the group without MenC vaccine. The proportion of participants with an anti-MenC SBA titre ?8 assessed one month after the second dose of MenC vaccine was 100% in the coadministration group. Both primary objectives were achieved.Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups.ClinicalTrials.gov identifier: NCT01839175; EudraCT number: 2012-005547-24. |
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| Keywords: | Immunogenicity Safety Vaccination Hexavalent Meningococcal C Co-administration |
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