Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare)(Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare))

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

Tetanustyphoid toxoid conjugate vaccine、Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine、Typhoid Vi conjugate vaccine

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染其他疾病

在研适应症

伤寒

非在研适应症-

原研机构

Zydus Lifesciences Ltd.

在研机构

Zydus Lifesciences Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2020-01-09),

伤寒

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

4

项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的临床试验

CTRI/2019/07/019996 / Recruiting临床4期

A prospective, open-label, multicenter, phase IV clinical study to evaluate the long term persistence of immunological response after primary vaccination with Typhoid Vi Conjugate Vaccine and response to booster dose vaccination with Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Limited in healthy subjects - None

开始日期2019-07-15

申办/合作机构

Zydus Lifesciences Ltd.

CTRI/2016/05/006975 / Completed临床2/3期

A prospective, randomized, two-arm, parallel, single-blind, active-controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Typhoid ViCapsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s Cadila HealthcareLimited compared to Typhoid Vi Capsular Polysaccharide Tetanus Toxoid ConjugateVaccine of M/s Bharat Biotech International Limited in healthy subjects - None

开始日期2016-06-03

申办/合作机构

Zydus Lifesciences Ltd.

CTRI/2015/04/005710 / Completed临床1期

AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF TYPHOID (Vi CAPSULAR POLYSACCHARIDE) TETANUS TOXOID CONJUGATE VACCINE OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY, ADULT, MALE, HUMAN SUBJECTS. - TYTTSD 1001

开始日期2015-04-24

申办/合作机构-

100 项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的临床结果

登录后查看更多信息

100 项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的转化医学

登录后查看更多信息

100 项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的专利（医药）

登录后查看更多信息

176

项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的文献（医药）

2024-03-01·Pediatric Research

Correction: Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study

作者: Brabec, Brad ; Simon, Michael ; Deseda, Carmen ; Von Barbier, Dalia ; Zambrano, Betzana ; Jordanov, Emilia ; Spiegel, Craig A ; Pan, Judy ; Áñez, Germán ; Dhingra, Mandeep Singh ; Anderson, Marc ; Hagenbach, Audrey ; Seyler, Clifford ; Julien, Katie ; Peterson, James ; Shi, Jiayuan ; Hoki, Robert ; Varghese, Kucku

2023-09-01·Pediatric Research

Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study

Article

作者: Brabec, Brad ; Simon, Michael ; Deseda, Carmen ; Von Barbier, Dalia ; Zambrano, Betzana ; Jordanov, Emilia ; Spiegel, Craig A ; Pan, Judy ; Áñez, Germán ; Dhingra, Mandeep Singh ; Anderson, Marc ; Seyler, Clifford ; Hagenbach, Audrey ; Julien, Katie ; Peterson, James ; Shi, Jiayuan ; Hoki, Robert ; Varghese, Kucku

AbstractBackgroundThe immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13–25-year olds who received MenACYW-TT or a CRM-conjugate vaccine (MCV4-CRM) 3–6 years earlier.MethodsThis phase IIIb open-label trial (NCT04084769) evaluated MenACYW-TT-primed participants, randomized to receive MenACYW-TT alone or with a MenB vaccine, and MCV4-CRM-primed participants who received MenACYW-TT alone. Functional antibodies against serogroups A, C, W and Y were measured using human complement serum bactericidal antibody assay (hSBA). The primary endpoint was vaccine seroresponse (post-vaccination titers ≥1:16 if pre-vaccination titers <1:8; or a ≥4-fold increase if pre-vaccination titers ≥1:8) 30 days post booster. Safety was evaluated throughout the study.ResultsThe persistence of the immune response following primary vaccination with MenACYW-TT was demonstrated. Seroresponse after MenACYW-TT booster was high regardless of priming vaccine (serogroup A: 94.8% vs 93.2%; C: 97.1% vs 98.9%; W: 97.7% vs 98.9%; and Y; 98.9% vs 100% for MenACWY-TT-primed and MCV4-CRM-primed groups, respectively). Co-administration with MenB vaccines did not affect MenACWY-TT immunogenicity. No vaccine-related serious adverse events were reported.ConclusionsMenACYW-TT booster induced robust immunogenicity against all serogroups, regardless of the primary vaccine received, and had an acceptable safety profile.Impact

A booster dose of MenACYW-TT induces robust immune responses in children and adolescents primed with MenACYW-TT or another MCV4 (MCV4-DT or MCV4-CRM), respectively.

Here, we demonstrate that MenACYW-TT booster 3–6 years after primary vaccination induced robust immunogenicity against all serogroups, regardless of the priming vaccine (MenACWY-TT or MCV4-CRM), and was well tolerated.

Persistence of the immune response following previous primary vaccination with MenACYW-TT was demonstrated.

MenACYW-TT booster with MenB vaccine co-administration did not affect MenACWY-TT immunogenicity and was well tolerated.

These findings will facilitate the provision of broader protection against IMD particularly in higher-risk groups such as adolescents.

2023-08-01·iScience

Immune responses against group B Streptococcus monovalent and pentavalent capsular polysaccharide tetanus toxoid conjugate vaccines in Balb/c mice

Article

作者: Kirstein, Frank ; Mohamed, Ebrahim ; Harden, Lois M ; Tippoo, Patrick ; Madhi, Shabir A ; Veeraraghavan, Balaji ; Jardine, Kimberly ; Anderson, Taigh ; Dhar, Nisha ; Kwatra, Gaurav ; Wilson, Seanette ; Williams, Matthew ; van Zyl, Petrus ; Dorasamy, Shantal ; Robertson, Madelyn Johnstone

Immunization of pregnant women with Group B Streptococcus (GBS) capsular polysaccharide (CPS) conjugate vaccine (CV) could protect young infants against invasive GBS disease. We evaluated the immunogenicity of investigational five GBS monovalent (serotypes Ia, Ib, II, III, and V) CPS-tetanus toxoid (TT)-CV with adjuvant and GBS pentavalent CPS-TT-CV with adjuvant (GBS5-CV-adj) and without adjuvant (GBS5-CV-no-adj), in Balb/c mice. Aluminum phosphate was the adjuvant in the formulations, where included. The homotypic immunoglobulin G (IgG) geometric mean concentration (GMC) and opsonophagocytic activity (OPA) geometric mean titer (GMT) did not differ after the third dose of the GBS5-CV-adj vaccine compared with the monovalent counterparts for all five serotypes. The GBS5-CV-adj induced higher post-vaccination serotype-specific IgG GMCs and OPA GMTs compared to GBS5-CV-no_adj. The GBS5-CV with and without adjuvant should be considered for further development as a potential vaccine for pregnant women to protect their infants against invasive GBS disease.

100 项与 Typhoid-tetanus toxoid conjugate vaccine (Cadila Healthcare) 相关的药物交易

登录后查看更多信息