A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and older

开始日期2009-06-18

申办/合作机构

Sanofi Pasteur MSD SNC

NCT00655148 / Completed临床3期

Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age

The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.

开始日期2003-09-01

申办/合作机构

Statens Serum Institute

100 项与 DTaP-poliovirus vaccine(Statens Serum Institute) 相关的临床结果

登录后查看更多信息

100 项与 DTaP-poliovirus vaccine(Statens Serum Institute) 相关的转化医学

登录后查看更多信息

100 项与 DTaP-poliovirus vaccine(Statens Serum Institute) 相关的专利（医药）

登录后查看更多信息

项与 DTaP-poliovirus vaccine(Statens Serum Institute) 相关的文献（医药）

2024-08-01·Infectious Diseases and Therapy

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study

Article

作者: Bertrand-Gerentes, Isabelle ; Simkó, Róbert ; Bchir, Siham ; Díez-Domingo, Javier ; Chong, Chan Poh ; Syrkina, Olga ; Zocchetti, Céline ; Icardi, Giancarlo

INTRODUCTIONMany immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi^®) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix^®) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents.METHODSIn this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status.RESULTSA total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified.CONCLUSIONSThese data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents.TRIAL REGISTRATIONSClinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973.

2022-11-01·Vaccine

An observational, cohort, multi-centre, open label phase IV extension study comparing preschool DTAP-IPV booster vaccine responses in children whose mothers were randomised to one of two pertussis-containing vaccines or received no pertussis-containing vaccine in pregnancy in England

Article

作者: Sapuan, Shari ; Heath, Paul T ; Matheson, Mary ; Andrews, Nick ; Hallis, Bassam ; Hole, Laura ; Miller, Elizabeth ; Snape, Matthew D ; Jones, Christine E

An antenatal pertussis vaccination programme was introduced in 2012 in the UK in the context of a national outbreak of pertussis. It has been shown that a lower antibody response to primary immunisation can be seen for certain pertussis antigens in infants born to women who received pertussis-containing antenatal vaccines, a phenomenon known as blunting. The longer-term impact of this has not been documented previously, and accordingly was evaluated in this study. Children were predominantly recruited from a previous study in which their mothers had received acellular pertussis-containing antenatal vaccines (dTaP₃-IPV [diphtheria toxoid, tetanus toxoid, three antigen acellular pertussis and inactivated polio] or dTaP₅-IPV [diphtheria toxoid, tetanus toxoid, five antigen acellular pertussis and inactivated polio]), or no pertussis-containing vaccine. Blood samples were obtained prior to and one month after the acellular pertussis-containing preschool booster (dTaP₅-IPV) was given at around age 3 years 4 months. Pre- and post-booster immunoglobulin G (IgG) geometric mean concentrations (GMCs) against pertussis toxin, filamentous haemagglutinin, fimbriae 2 & 3, and pertactin, were compared. Prior to the receipt of the preschool booster, there was no difference in the IgG GMCs against pertussis-specific antigens between children born to women vaccinated with dTaP₃-IPV and dTaP₅-IPV; however, IgG GMCs against pertussis toxin were significantly lower in children born to women vaccinated with dTaP₃-IPV compared with children born to unvaccinated women (geometric mean ratio 0.42 [95 % CI 0.22-0.78], p = 0.03). One month after the receipt of the preschool booster there was no differences between the groups. The blunting effect of antenatal pertussis vaccine on pertussis responses in children can persist until preschool age, although it is overcome by the administration of a booster dose. ClinicalTrials.gov registration number: NCT03578120.

2022-09-02·Expert Review of Vaccines

A combined DTaP-IPV vaccine (Tetraxim®/Tetravac®) used as school-entry booster: a review of more than 20 years of clinical and post-marketing experience

Review

作者: Vargas-Zambrano, Juan ; Macina, Denis ; Huoi, Catherine ; Vidor, Emmanuel

INTRODUCTIONRoutine infant primary series and toddler booster vaccination are associated with waning of antibody levels over time, which can lead to an increased incidence of vaccine-preventable diseases. A diphtheria-tetanus-pertussis (DTP) booster vaccination at school-entry (aged 4-7 years) allows continued protection against these diseases and is included in many national immunization programs.AREAS COVEREDThe available immunogenicity and safety data from 6 clinical studies of a diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTaP-IPV [Tetraxim®]) used as a school-entry booster vaccination were identified using a PubMed search or on file at Sanofi. The studies spanned a 15-year period (1995-2010) and were performed in different populations using different study designs, so all data were reviewed descriptively (no meta-analyses were conducted). Additionally, post-marketing experience was reviewed.EXPERT OPINIONEach vaccine antigen is highly immunogenic, and the safety profile of the vaccine is satisfactory. Post-marketing evaluations have shown the effectiveness of a school-age booster, particularly against increased pertussis disease incidence around the time of school entry and the associated risk of spreading the disease through contact with younger vulnerable infants. School-entry provides an ideal opportunity to implement DTaP-IPV vaccination to close the gap between waning immunity from the previous infant/toddler vaccination and future adolescent vaccination.

100 项与 DTaP-poliovirus vaccine(Statens Serum Institute) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA02	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
白喉	丹麦	Statens Serum Institute	1997-05-12
脊髓灰质炎	丹麦	Statens Serum Institute	1997-05-12
破伤风	丹麦	Statens Serum Institute	1997-05-12
百日咳	丹麦	Statens Serum Institute	1997-05-12