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Adam Finn - One of the best experts on this subject based on the ideXlab platform.
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a phase iii open label randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria tetanus acellular pertussis polio Vaccines when co administered with measles mumps Rubella vac
Vaccine, 2018Co-Authors: Robin D Marlow, Sherine Kuriyakose, Narcisa Mesaros, Richard Tomlinson, Saul N Faust, Matthew D Snape, Andrew J Pollard, Adam FinnAbstract:Abstract Aim To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) Vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPVR (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-Rubella Vaccine (MMRV). Methods This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV Vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study Vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPVB Vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study Vaccines were evaluated. Results 387 children were randomised and 385 vaccinated: 255 in the dTap-IPVB group and 130 in the dTap-IPVR group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both Vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPVB group. Conclusion Non-inferiority of dTap-IPVB to dTap-IPVR was demonstrated. Both Vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 ( ClinicalTrials.gov )
Yuxi Zhang - One of the best experts on this subject based on the ideXlab platform.
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Immunogenicity and safety of measles-Rubella Vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 Vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.
The Lancet. Infectious diseases, 2019Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi ZhangAbstract:Summary Background In China, measles-Rubella Vaccine and live attenuated SA 14–14–2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these Vaccines worldwide. We aimed to assess the effect of the co-administration of these Vaccines at 8 months of age on the immunogenicity of measles-Rubella Vaccine. Methods We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-Rubella Vaccine and LJEV simultaneously (measles-Rubella plus LJEV group) or measles-Rubella Vaccine alone (measles-Rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for Rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov ( NCT02643433 ). Findings 1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-Rubella plus LJEV group and 548 to the measles-Rubella group. Of the infants assigned to each group, 507 in the measles-Rubella plus LJEV group and 506 in the measles-Rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-Rubella plus LJEV group and one ( Interpretation The evidence of similar seroconversion and safety with co-administered LJEV and measles-Rubella Vaccines supports the co-administration of these Vaccines to infants aged 8 months. These results will be important for measles and Rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic. Funding US Centers for Disease Control and Prevention, US Department of Health and Human Services; China–US Collaborative Program on Emerging and Re-emerging Infectious Diseases.
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immunogenicity and safety of co administered live attenuated japanese encephalitis sa 14 14 2 Vaccine and measles Rubella Vaccine compared with measles Rubella Vaccine alone in infants 8 months of age china
Social Science Research Network, 2018Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi Zhang, Zhiping Zuo, Lance Rodewald, Qi-you XiaoAbstract:Background: Measles is one of the most contagious diseases ever known and is an important cause of death and disability among young children worldwide. Rubella is generally a mild disease in children and adults, but Rubella virus infection during pregnancy, especially during the first trimester, can result in miscarriage, fetal death, stillbirth, or infants with a constellation of congenital malformations known as congenital Rubella syndrome. A growing number of countries are adopting the use of the combined measles-Rubella Vaccine (MR) to prevent both diseases. In China, measles-Rubella Vaccine and live, attenuated SA-14-14-2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at age 8 months, which is the earliest recommended age globally. Evidence is limited whether co-administering MR and LJEV at 8 months of age will impact immunogenicity of MR antigens. Methods: We conducted a prospective, two-arm randomized trial between August 2015 and June 2016 in two provinces in China to determine whether at 8 months of age, seroconversion to measles antibody and Rubella antibody 6 weeks after co-administration of MR and LJEV was non-inferior to seroconversion 6 weeks after administration of MR without LJEV. Measles immunoglobulin G (IgG) and Rubella IgG antibody levels were determined using an enzyme-linked immunosorbent assay on blood samples collected before vaccination and six weeks (42-48 days) post-vaccination. For non-inferiority tests, we calculated a two-sided, 90% (Farrington-Manning) confidence bound of the difference in antibody levels between persons who received MR LJEV and those who received MR alone. Solicited and unsolicited adverse events following immunization (AEFI) were recorded for all infants who completed the study. Findings: Of 1,093 enrolled infants, 507 in the MR LJEV group and 506 in the MR-only group completed the study. Before vaccination, 1.2% in MR LJEV group and 0.2% in the MR-only group were seropositive for measles antibody (p=0.13); 1.6% in MR LJEV group and 0.4% in the MR-only group were seropositive for Rubella antibody (p=0.11). Six weeks after vaccination, measles antibody seroconversion rates were 97.8% in the MR LJEV group compared to 98.6% in the MR-only group (non-inferior; p<0.0001). Six weeks after vaccination, Rubella antibody seroconversion rates were 94.3% in the MR LJEV group compared to 93.5% in the MR-only group (non-inferior; p<0.0001). Mild local reactions included redness, swelling and pain; systemic reactions included fever, diarrhea and vomiting. There were no serious non-fatal or fatal AEFIs. Interpretation: The high seroconversion rates, non-inferiority, and safety of co-administered LJEV and MR found in this randomized trial provide support for the co-administration of these live attenuated Vaccines in infants, a finding of importance to the global priorities of measles elimination and expansion of JE vaccination in endemic countries. Funding: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2014-2015 Research Program Seven, China-US Collaborative Program on Emerging and Reemerging Infectious Diseases. Conflict of Interests: The authors declare that they have no competing interests. Ethical Approval Statement: This study was approved by the Ethical Review Committee of Chinese Center for Disease Control and Prevention (approval number: 201518); US CDC was designated as a non-engaged collaborator for Institutional Review Board purposes. Parents or legal guardians of participating infants signed an informed consent prior to study enrollment and allocation to study group.
Susan Y. Chu - One of the best experts on this subject based on the ideXlab platform.
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Immunogenicity and safety of measles-Rubella Vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 Vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.
The Lancet. Infectious diseases, 2019Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi ZhangAbstract:Summary Background In China, measles-Rubella Vaccine and live attenuated SA 14–14–2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these Vaccines worldwide. We aimed to assess the effect of the co-administration of these Vaccines at 8 months of age on the immunogenicity of measles-Rubella Vaccine. Methods We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-Rubella Vaccine and LJEV simultaneously (measles-Rubella plus LJEV group) or measles-Rubella Vaccine alone (measles-Rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for Rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov ( NCT02643433 ). Findings 1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-Rubella plus LJEV group and 548 to the measles-Rubella group. Of the infants assigned to each group, 507 in the measles-Rubella plus LJEV group and 506 in the measles-Rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-Rubella plus LJEV group and one ( Interpretation The evidence of similar seroconversion and safety with co-administered LJEV and measles-Rubella Vaccines supports the co-administration of these Vaccines to infants aged 8 months. These results will be important for measles and Rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic. Funding US Centers for Disease Control and Prevention, US Department of Health and Human Services; China–US Collaborative Program on Emerging and Re-emerging Infectious Diseases.
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immunogenicity and safety of co administered live attenuated japanese encephalitis sa 14 14 2 Vaccine and measles Rubella Vaccine compared with measles Rubella Vaccine alone in infants 8 months of age china
Social Science Research Network, 2018Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi Zhang, Zhiping Zuo, Lance Rodewald, Qi-you XiaoAbstract:Background: Measles is one of the most contagious diseases ever known and is an important cause of death and disability among young children worldwide. Rubella is generally a mild disease in children and adults, but Rubella virus infection during pregnancy, especially during the first trimester, can result in miscarriage, fetal death, stillbirth, or infants with a constellation of congenital malformations known as congenital Rubella syndrome. A growing number of countries are adopting the use of the combined measles-Rubella Vaccine (MR) to prevent both diseases. In China, measles-Rubella Vaccine and live, attenuated SA-14-14-2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at age 8 months, which is the earliest recommended age globally. Evidence is limited whether co-administering MR and LJEV at 8 months of age will impact immunogenicity of MR antigens. Methods: We conducted a prospective, two-arm randomized trial between August 2015 and June 2016 in two provinces in China to determine whether at 8 months of age, seroconversion to measles antibody and Rubella antibody 6 weeks after co-administration of MR and LJEV was non-inferior to seroconversion 6 weeks after administration of MR without LJEV. Measles immunoglobulin G (IgG) and Rubella IgG antibody levels were determined using an enzyme-linked immunosorbent assay on blood samples collected before vaccination and six weeks (42-48 days) post-vaccination. For non-inferiority tests, we calculated a two-sided, 90% (Farrington-Manning) confidence bound of the difference in antibody levels between persons who received MR LJEV and those who received MR alone. Solicited and unsolicited adverse events following immunization (AEFI) were recorded for all infants who completed the study. Findings: Of 1,093 enrolled infants, 507 in the MR LJEV group and 506 in the MR-only group completed the study. Before vaccination, 1.2% in MR LJEV group and 0.2% in the MR-only group were seropositive for measles antibody (p=0.13); 1.6% in MR LJEV group and 0.4% in the MR-only group were seropositive for Rubella antibody (p=0.11). Six weeks after vaccination, measles antibody seroconversion rates were 97.8% in the MR LJEV group compared to 98.6% in the MR-only group (non-inferior; p<0.0001). Six weeks after vaccination, Rubella antibody seroconversion rates were 94.3% in the MR LJEV group compared to 93.5% in the MR-only group (non-inferior; p<0.0001). Mild local reactions included redness, swelling and pain; systemic reactions included fever, diarrhea and vomiting. There were no serious non-fatal or fatal AEFIs. Interpretation: The high seroconversion rates, non-inferiority, and safety of co-administered LJEV and MR found in this randomized trial provide support for the co-administration of these live attenuated Vaccines in infants, a finding of importance to the global priorities of measles elimination and expansion of JE vaccination in endemic countries. Funding: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2014-2015 Research Program Seven, China-US Collaborative Program on Emerging and Reemerging Infectious Diseases. Conflict of Interests: The authors declare that they have no competing interests. Ethical Approval Statement: This study was approved by the Ethical Review Committee of Chinese Center for Disease Control and Prevention (approval number: 201518); US CDC was designated as a non-engaged collaborator for Institutional Review Board purposes. Parents or legal guardians of participating infants signed an informed consent prior to study enrollment and allocation to study group.
Robin D Marlow - One of the best experts on this subject based on the ideXlab platform.
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a phase iii open label randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria tetanus acellular pertussis polio Vaccines when co administered with measles mumps Rubella vac
Vaccine, 2018Co-Authors: Robin D Marlow, Sherine Kuriyakose, Narcisa Mesaros, Richard Tomlinson, Saul N Faust, Matthew D Snape, Andrew J Pollard, Adam FinnAbstract:Abstract Aim To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) Vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPVR (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-Rubella Vaccine (MMRV). Methods This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV Vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study Vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPVB Vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study Vaccines were evaluated. Results 387 children were randomised and 385 vaccinated: 255 in the dTap-IPVB group and 130 in the dTap-IPVR group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both Vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPVB group. Conclusion Non-inferiority of dTap-IPVB to dTap-IPVR was demonstrated. Both Vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 ( ClinicalTrials.gov )
Fubin Zhang - One of the best experts on this subject based on the ideXlab platform.
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Immunogenicity and safety of measles-Rubella Vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 Vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.
The Lancet. Infectious diseases, 2019Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi ZhangAbstract:Summary Background In China, measles-Rubella Vaccine and live attenuated SA 14–14–2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these Vaccines worldwide. We aimed to assess the effect of the co-administration of these Vaccines at 8 months of age on the immunogenicity of measles-Rubella Vaccine. Methods We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-Rubella Vaccine and LJEV simultaneously (measles-Rubella plus LJEV group) or measles-Rubella Vaccine alone (measles-Rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for Rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov ( NCT02643433 ). Findings 1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-Rubella plus LJEV group and 548 to the measles-Rubella group. Of the infants assigned to each group, 507 in the measles-Rubella plus LJEV group and 506 in the measles-Rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-Rubella plus LJEV group and one ( Interpretation The evidence of similar seroconversion and safety with co-administered LJEV and measles-Rubella Vaccines supports the co-administration of these Vaccines to infants aged 8 months. These results will be important for measles and Rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic. Funding US Centers for Disease Control and Prevention, US Department of Health and Human Services; China–US Collaborative Program on Emerging and Re-emerging Infectious Diseases.
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immunogenicity and safety of co administered live attenuated japanese encephalitis sa 14 14 2 Vaccine and measles Rubella Vaccine compared with measles Rubella Vaccine alone in infants 8 months of age china
Social Science Research Network, 2018Co-Authors: Susan Y. Chu, Chenyan Yue, Kathleen Wannemuehler, Shuyun Xie, Fubin Zhang, Yamin Wang, Yuxi Zhang, Zhiping Zuo, Lance Rodewald, Qi-you XiaoAbstract:Background: Measles is one of the most contagious diseases ever known and is an important cause of death and disability among young children worldwide. Rubella is generally a mild disease in children and adults, but Rubella virus infection during pregnancy, especially during the first trimester, can result in miscarriage, fetal death, stillbirth, or infants with a constellation of congenital malformations known as congenital Rubella syndrome. A growing number of countries are adopting the use of the combined measles-Rubella Vaccine (MR) to prevent both diseases. In China, measles-Rubella Vaccine and live, attenuated SA-14-14-2 Japanese encephalitis Vaccine (LJEV) are recommended for simultaneous administration at age 8 months, which is the earliest recommended age globally. Evidence is limited whether co-administering MR and LJEV at 8 months of age will impact immunogenicity of MR antigens. Methods: We conducted a prospective, two-arm randomized trial between August 2015 and June 2016 in two provinces in China to determine whether at 8 months of age, seroconversion to measles antibody and Rubella antibody 6 weeks after co-administration of MR and LJEV was non-inferior to seroconversion 6 weeks after administration of MR without LJEV. Measles immunoglobulin G (IgG) and Rubella IgG antibody levels were determined using an enzyme-linked immunosorbent assay on blood samples collected before vaccination and six weeks (42-48 days) post-vaccination. For non-inferiority tests, we calculated a two-sided, 90% (Farrington-Manning) confidence bound of the difference in antibody levels between persons who received MR LJEV and those who received MR alone. Solicited and unsolicited adverse events following immunization (AEFI) were recorded for all infants who completed the study. Findings: Of 1,093 enrolled infants, 507 in the MR LJEV group and 506 in the MR-only group completed the study. Before vaccination, 1.2% in MR LJEV group and 0.2% in the MR-only group were seropositive for measles antibody (p=0.13); 1.6% in MR LJEV group and 0.4% in the MR-only group were seropositive for Rubella antibody (p=0.11). Six weeks after vaccination, measles antibody seroconversion rates were 97.8% in the MR LJEV group compared to 98.6% in the MR-only group (non-inferior; p<0.0001). Six weeks after vaccination, Rubella antibody seroconversion rates were 94.3% in the MR LJEV group compared to 93.5% in the MR-only group (non-inferior; p<0.0001). Mild local reactions included redness, swelling and pain; systemic reactions included fever, diarrhea and vomiting. There were no serious non-fatal or fatal AEFIs. Interpretation: The high seroconversion rates, non-inferiority, and safety of co-administered LJEV and MR found in this randomized trial provide support for the co-administration of these live attenuated Vaccines in infants, a finding of importance to the global priorities of measles elimination and expansion of JE vaccination in endemic countries. Funding: Centers for Disease Control and Prevention, US Department of Health and Human Services. 2014-2015 Research Program Seven, China-US Collaborative Program on Emerging and Reemerging Infectious Diseases. Conflict of Interests: The authors declare that they have no competing interests. Ethical Approval Statement: This study was approved by the Ethical Review Committee of Chinese Center for Disease Control and Prevention (approval number: 201518); US CDC was designated as a non-engaged collaborator for Institutional Review Board purposes. Parents or legal guardians of participating infants signed an informed consent prior to study enrollment and allocation to study group.
