The Experts below are selected from a list of 162 Experts worldwide ranked by ideXlab platform
Dalya Guris - One of the best experts on this subject based on the ideXlab platform.
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An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) Vaccine given concomitantly with diphtheria, tetanus, pertussis, and Poliomyelitis Vaccine in healthy
The Pediatric infectious disease journal, 2010Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.
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an open label randomized multicenter study of the safety tolerability and immunogenicity of quadrivalent human papillomavirus types 6 11 16 18 Vaccine given concomitantly with diphtheria tetanus pertussis and Poliomyelitis Vaccine in healthy adolesce
Pediatric Infectious Disease Journal, 2009Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.
Martine Baudin - One of the best experts on this subject based on the ideXlab platform.
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Immunogenicity and safety of one dose of diphtheria, tetanus, acellular pertussis and Poliomyelitis Vaccine (Repevax®) followed by two doses of diphtheria, tetanus and Poliomyelitis Vaccine (Revaxis®) in adults aged ≥40 years not receiving a diphther
Vaccine, 2014Co-Authors: Rolf Dominicus, Florence Galtier, Patrick Richard, Martine BaudinAbstract:INTRODUCTION: The immunogenicity and safety of one dose of Tdap-IPV (tetanus, diphtheria, acellular pertussis and inactivated Poliomyelitis Vaccine) and two doses of Td-IPV (tetanus, diphtheria and inactivated Poliomyelitis Vaccine) were assessed in adults who had not received a diphtheria- and tetanus-containing Vaccine in the last 20 years. METHODS: This open-label, multicentre study was conducted in adults aged ≥ 40 years with no diphtheria- and tetanus-containing Vaccine in the last 20 years. Participants received one dose of Tdap-IPV followed by two doses of Td-IPV (0, 1, 6 month schedule). Primary immunogenicity objectives: to demonstrate acceptable seroprotection rates (percentage of participants with antibody titre above threshold) post-dose 3 for diphtheria (≥ 0.1IU/mL by seroneutralization assay [SNA]); tetanus (≥ 0.1IU/mL by enzyme-linked immunosorbent assay [ELISA]); and Poliomyelitis (≥ 8 1/dil by SNA); and to evaluate the percentage of participants with an antibody concentration ≥ 5EU/mL (by ELISA) for pertussis antigens post-dose 1. Seroprotection rates were acceptable if the lower limit of the 95% confidence interval (CI) was >95%. Percentage of participants with basic clinical immunity against diphtheria (≥ 0.01IU/mL) was also assessed. Safety (adverse events [AEs] and serious AEs) was assessed after each dose. RESULTS: Overall, 336 participants were included (mean age: 60.2 years). Post-dose 3 seroprotection rates were: diphtheria, 94.6% (CI 91.5-96.8); tetanus and Poliomyelitis, 100% (CI: 98.8-100). Percentage of participants with an antibody titre ≥ 5EU/mL against pertussis antigens was ≥ 95.8% for all five pertussis components. Basic clinical immunity against diphtheria was achieved in 100% (CI: 98.8-100) of participants. AEs were reported more frequently following vaccination with Tdap-IPV (post-dose 1: 65.3%) than with Td-IPV (post-dose 2: 48.3%; post-dose 3: 50.3%). CONCLUSIONS: This study highlights the benefits of using Tdap-IPV followed by two doses of Td-IPV in an adult population to achieve maximal protection against diphtheria, tetanus, Poliomyelitis and pertussis simultaneously.
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Immunogenicity and safety of one dose of diphtheria, tetanus, acellular pertussis and Poliomyelitis Vaccine (Repevax®) followed by two doses of diphtheria, tetanus and Poliomyelitis Vaccine (Revaxis®) in adults aged ≥40 years not receiving a diphther
Vaccine, 2014Co-Authors: Rolf Dominicus, Florence Galtier, Patrick Richard, Martine BaudinAbstract:The immunogenicity and safety of one dose of Tdap-IPV (tetanus, diphtheria, acellular pertussis and inactivated Poliomyelitis Vaccine) and two doses of Td-IPV (tetanus, diphtheria and inactivated Poliomyelitis Vaccine) were assessed in adults who had not received a diphtheria- and tetanus-containing Vaccine in the last 20 years. This open-label, multicentre study was conducted in adults aged ≥ 40 years with no diphtheria- and tetanus-containing Vaccine in the last 20 years. Participants received one dose of Tdap-IPV followed by two doses of Td-IPV (0, 1, 6 month schedule). Primary immunogenicity objectives: to demonstrate acceptable seroprotection rates (percentage of participants with antibody titre above threshold) post-dose 3 for diphtheria (≥ 0.1IU/mL by seroneutralization assay [SNA]); tetanus (≥ 0.1IU/mL by enzyme-linked immunosorbent assay [ELISA]); and Poliomyelitis (≥ 8 1/dil by SNA); and to evaluate the percentage of participants with an antibody concentration ≥ 5EU/mL (by ELISA) for pertussis antigens post-dose 1. Seroprotection rates were acceptable if the lower limit of the 95% confidence interval (CI) was >95%. Percentage of participants with basic clinical immunity against diphtheria (≥ 0.01IU/mL) was also assessed. Safety (adverse events [AEs] and serious AEs) was assessed after each dose. Overall, 336 participants were included (mean age: 60.2 years). Post-dose 3 seroprotection rates were: diphtheria, 94.6% (CI 91.5-96.8); tetanus and Poliomyelitis, 100% (CI: 98.8-100). Percentage of participants with an antibody titre ≥ 5EU/mL against pertussis antigens was ≥ 95.8% for all five pertussis components. Basic clinical immunity against diphtheria was achieved in 100% (CI: 98.8-100) of participants. AEs were reported more frequently following vaccination with Tdap-IPV (post-dose 1: 65.3%) than with Td-IPV (post-dose 2: 48.3%; post-dose 3: 50.3%). This study highlights the benefits of using Tdap-IPV followed by two doses of Td-IPV in an adult population to achieve maximal protection against diphtheria, tetanus, Poliomyelitis and pertussis simultaneously. Copyright © 2014 Elsevier Ltd. All rights reserved.
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immunogenicity and safety of a booster dose of diphtheria tetanus acellular pertussis and inactivated Poliomyelitis Vaccine tdap ipv repevax administered concomitantly versus non concomitantly with an influenza Vaccine vaxigrip to adults aged 60 year
Vaccine, 2013Co-Authors: Ulrich Zimmermann, Patrick Richard, Gaetan Gavazzi, Cecile Eymin, Benoit Soubeyrand, Martine BaudinAbstract:Abstract Background Annual influenza vaccination provides an opportunity to administer a booster dose of diphtheria, tetanus, acellular pertussis and inactivated Poliomyelitis Vaccine (Tdap-IPV) to the elderly. This study evaluated immune responses to and safety of the two Vaccines administered concomitantly or sequentially to elderly individuals in France and Germany. Methods Individuals aged ≥60 years who had received a diphtheria/tetanus booster within 5–15 years were randomised (1:1) to receive either Tdap-IPV and an inactivated influenza Vaccine concomitantly (Group 1) or inactivated influenza Vaccine then Tdap-IPV 28–35 days later (Group 2). Antibody titres were measured before and 28–35 days after each vaccination. Results The mean age of randomised individuals ( n = 954) was 68.8 years. Post-vaccination seroprotection rates (≥0.1 IU/mL for diphtheria/tetanus and ≥8 1/dilution for polio) for Group 1 were non-inferior to Group 2 for diphtheria (85.4% vs. 87.5%), tetanus (both 100%), polio type 1 (99.8% vs. 100%), polio type 2 (both 100%) and polio type 3 (99.3% vs. 99.8%). Similarly, percentages of individuals with pertussis antibodies ≥5 EU/mL for Group 1 were non-inferior to Group 2: pertussis toxin (94.3% vs. 98.1%), filamentous haemagglutinin (99.8% vs. 100%), pertactin (97.3% vs. 96.0%), fimbriae 2 and 3 (91.7% vs. 89.5%). Post-vaccination geometric mean titres of anti-influenza haemagglutinin antibodies for Group 1 were non-inferior to Group 2. Adverse events following administration of Tdap-IPV were similar in both study groups, with no Vaccine-related serious adverse events. Conclusion Tdap-IPV and inactivated influenza Vaccine can be administered concomitantly in the elderly without impairing tolerability or the immune response to either Vaccine.
Timo Vesikari - One of the best experts on this subject based on the ideXlab platform.
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An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) Vaccine given concomitantly with diphtheria, tetanus, pertussis, and Poliomyelitis Vaccine in healthy
The Pediatric infectious disease journal, 2010Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.
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an open label randomized multicenter study of the safety tolerability and immunogenicity of quadrivalent human papillomavirus types 6 11 16 18 Vaccine given concomitantly with diphtheria tetanus pertussis and Poliomyelitis Vaccine in healthy adolesce
Pediatric Infectious Disease Journal, 2009Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.
Howard Markel - One of the best experts on this subject based on the ideXlab platform.
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Making history: Thomas Francis, Jr, MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial.
Archives of pediatrics & adolescent medicine, 2000Co-Authors: Sarah Marie Lambert, Howard MarkelAbstract:The article focuses on the Poliomyelitis Vaccine field trial directed by Thomas Francis, Jr. MD, of the University of Michigan Vaccine Evaluation Center and sponsored by the National Foundation for Infantile Paralysis (NFIP) or, as it was better known to the public, the March of Dimes. It was a landmark in the widescale testing of a Vaccine and the ethical use of human subjects. Millions of American parents readily volunteered their healthy children to participate. A total of 150 000 volunteers, including schoolteachers, physicians, nurses, and health officers all endorsed the study and donated their time and effort to make it successful. i(p269) Avoiding the use of marginalized groups, the field trial purposefully did not involve institutionalized children; instead, it was based in 15 000 public schools in 44 of the 48 states as clinic sites. 1(268) A group of 650 000 children received some type of injection, either the Vaccine or a placebo, and another 1.18 million served as controls. 2 The field trial depended, most essentially, on both public support and the participation of millions of children who remained enrolled in a study that required a series of 3 injections and a 6-month evaluation period. Enlisting the huge number of participants presented practical examples of the difficulties in experimenting on human subjects. On April 26, 1954, Randy Kerr. a participant or Polio Pioneer as the children involved were called, received the first inoculation of the Salk Poliomyelitis Vaccine. The nationwide study designed to test the safety and efficacy 3(p177) of the Salk Vaccine had officially begun.
Niklas Lindblad - One of the best experts on this subject based on the ideXlab platform.
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An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) Vaccine given concomitantly with diphtheria, tetanus, pertussis, and Poliomyelitis Vaccine in healthy
The Pediatric infectious disease journal, 2010Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.
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an open label randomized multicenter study of the safety tolerability and immunogenicity of quadrivalent human papillomavirus types 6 11 16 18 Vaccine given concomitantly with diphtheria tetanus pertussis and Poliomyelitis Vaccine in healthy adolesce
Pediatric Infectious Disease Journal, 2009Co-Authors: Timo Vesikari, Pierre Van Damme, Niklas Lindblad, Ulrich Pfletschinger, David Radley, Desmond Ryan, Scott Vuocolo, Richard M. Haupt, Dalya GurisAbstract:Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) Vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other Vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and Poliomyelitis Vaccine). Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all Vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Results: Immune response for all GARDASIL antigens following concomitant administration of the Vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 Vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either Vaccine. Concomitant administration of Vaccines would minimize the number of visits required to deliver each Vaccine individually.