Clinical Trials associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

CTR20222834 / RecruitingPhase 1

评价吸附无细胞百白破灭活脊髓灰质炎联合疫苗在婴幼儿及儿童中接种的安全性及探索免疫原性的I期临床研究

[Translation] Phase I clinical study to evaluate the safety and immunogenicity of adsorbed acellular diphtheria, pertussis and tetanus combined inactivated poliomyelitis vaccine in infants and children

评价吸附无细胞百白破灭活脊髓灰质炎联合疫苗接种于2月龄至24月龄婴幼儿及4-6岁儿童的安全性；同时探索吸附无细胞百白破灭活脊髓灰质炎联合疫苗的免疫原性

[Translation]

To evaluate the safety of adsorbed acellular diphtheria, pertussis and tetanus combined with inactivated poliomyelitis vaccine in infants aged 2 to 24 months and children aged 4 to 6 years; to explore the immunogenicity of adsorbed acellular diphtheria, pertussis and tetanus combined with inactivated poliomyelitis vaccine

Start Date30 Oct 2022

Sponsor / Collaborator

Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd

[+1]

100 Clinical Results associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

100 Translational Medicine associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

100 Patents (Medical) associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

Literatures (Medical) associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

01 Apr 2005·VaccineQ3 · MEDICINE

Immunogenicity and safety of a combined hepatitis A and B vaccine administered concomitantly with either a measles–mumps–rubella or a diphtheria–tetanus–acellular pertussis-inactivated poliomyelitis vaccine mixed with a Haemophilus influenzae type b conjugate vaccine in infants aged 12–18 months

Q3 · MEDICINE

Article

Author: V. Bakasenas ; N. Tornieporth ; I. Lutsar ; M. Stoffel ; V. Usonis ; S. Meriste ; F. Collard

Two studies were undertaken to investigate the concomitant administration of combined hepatitis A/B vaccine with a diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae vaccine (DTPa-IPV/Hib), or with a measles-mumps-rubella vaccine (MMR), during the second year of life. On completion of the vaccination course, all subjects were seropositive or seroprotected against all antigens except for one subject who was seronegative for anti-PT. Seropositivity and seroprotection rates for all other antibodies were comparable to reference values for each vaccine component, indicating that the immunogenicity of MMR, DTPa-IPV/Hib and combined hepatitis A/B vaccines is not impaired by co-administration. All vaccines were well tolerated.

01 Nov 1995·Clinical Infectious DiseasesQ1 · MEDICINE

Antibody Response to Diphtheria, Tetanus, and Poliomyelitis Vaccines in Relation to the Number of CD4+ T Lymphocytes in Adults Infected with Human Immunodeficiency Virus

Q1 · MEDICINE

Article

Author: van Dissel, J T ; Kroon, F P ; Labadie, J ; van Furth, R ; van Loon, A M

A prospective study of antibody production by adults infected with human immunodeficiency virus (HIV) after vaccination with T lymphocyte-dependent diphtheria toxoid, tetanus toxoid, and inactivated trivalent poliovirus vaccine was conducted. Individuals were divided into three groups according to CD4+ T-lymphocyte count: group 1 had a count of < or = 100-300 x 10(6)/L; and group 3, > 300 x 10(6)/L. After vaccination, 61%, 70%, and 73% of the individuals in groups 1, 2, and 3, respectively, developed protective titers of antibody to diphtheria toxin; the mean postvaccination antibody titer of HIV-infected individuals was significantly lower than that of healthy controls not infected with HIV. Furthermore, the mean titers of antibodies to tetanus toxin and poliovirus were significantly lower in HIV-infected individuals with CD4+ lymphocyte counts of < 300 x 10(6)/L than in controls. Of the HIV-infected vaccinees, 83%-100% were protected against tetanus and 78%-100% against polio. We conclude that HIV-infected individuals with CD4+ lymphocyte counts of < 300 x 10(6)/L have an impaired (secondary) antibody response after receipt of T lymphocyte-dependent vaccines.

100 Deals associated with Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 1	CN	Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd	30 Oct 2022
Diphtheria	Phase 1	CN	Wuhan Institute of Biological Products Co., Ltd.	30 Oct 2022
Poliomyelitis	Phase 1	CN	Wuhan Institute of Biological Products Co., Ltd.	30 Oct 2022
Poliomyelitis	Phase 1	CN	Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd	30 Oct 2022
Tetanus	Phase 1	CN	Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd	30 Oct 2022
Tetanus	Phase 1	CN	Wuhan Institute of Biological Products Co., Ltd.	30 Oct 2022
Whooping Cough	Phase 1	CN	Wuhan Institute of Biological Products Co., Ltd.	30 Oct 2022
Whooping Cough	Phase 1	CN	Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd	30 Oct 2022

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Diphtheria,Tetanus, Acellular Pertussis and Poliomyelitis Combined Vaccine, Inactivated, Adsorbed(Wuhan Institute of Biological Products/National Vaccine & Serum Institute)

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