Varicella Virus Vaccine(Novartis Vaccines)(Varicella Virus Vaccine(Novartis Vaccines))

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病其他疾病

在研适应症-

非在研适应症

流行性脑脊髓膜炎

原研机构

Novartis Vaccines & Diagnostics, Inc.

在研机构-

非在研机构

Novartis Vaccines & Diagnostics, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的临床试验

NCT00806195 / Completed临床3期

A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

开始日期2008-12-01

申办/合作机构

Novartis AG

NCT00310856 / Completed临床2期

A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

开始日期2005-06-01

申办/合作机构-

100 项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的临床结果

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100 项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的转化医学

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100 项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的专利（医药）

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43

项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的文献（医药）

2021-11-02·Human Vaccines & Immunotherapeutics3区 · 医学

Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX™) in healthy adults

3区 · 医学

Article

作者: Tikhonov, Oleg ; Paradis, Erin M. ; Kharit, Susanna M. ; Cao, Xin ; Platt, Heather L. ; Fokin, Aleksandr ; Banniettis, Natalie

Varicella (chickenpox) is a common, highly contagious disease caused by primary infection with varicella zoster virus (VZV). Adults typically experience more severe symptoms than children and have a higher risk of developing complications. Stage 1 of this Phase 3 open-label study enrolled healthy adults in Russia aged 18-75 years without a clinical history of varicella infection. Eligible participants (n = 50) were administered 2 doses of VARIVAX™ (Varicella Virus Vaccine Live [Oka/Merck]) 0.5 mL 6 weeks apart. For participants seronegative at baseline (VZV antibody titer <1.25 glycoprotein enzyme-linked immuno-sorbent assay [gpELISA] units/mL), immunogenicity was assessed by seroconversion (VZV antibody titer ≥5 gpELISA units/mL) and assessment of geometric mean titers of VZV antibody as measured by gpELISA 6 weeks after Dose 2. For VZV seropositive participants at baseline (VZV antibody titer ≥1.25 gpELISA units/mL), immunogenicity was assessed by geometric mean fold rise in antibody titer and percentage of participants with a ≥ 4-fold rise in antibody titer 6 weeks after Dose 2. A Vaccine Report Card was used to record solicited and unsolicited adverse events through 42 days post-vaccination. All participants who were seronegative (n = 26) at baseline demonstrated seroconversion 6 weeks after Dose 2. Among participants who were seropositive at baseline (n = 23), 60.9% had a ≥4-fold rise in antibody titer 6 weeks after Dose 2. Vaccination was generally well tolerated, with no new safety signals identified. Administration of 2 doses of VARIVAX in adults in Russia results in acceptable immune responses with safety data consistent with the licensed product (Clinicaltrials.gov identifier: NCT03843632).

2021-11-02·Human Vaccines & Immunotherapeutics3区 · 医学

Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX™) in healthy infants, children, and adolescents

3区 · 医学

Article

作者: Tikhonov, Oleg ; Paradis, Erin M. ; Wittke, Frederick ; Jotterand, Veronika ; Cao, Xin ; Kharit, Susanna M. ; Platt, Heather L. ; Fokin, Aleksandr

Varicella (chickenpox) is a common, highly contagious disease caused by primary infection with varicella zoster virus (VZV), which can result in bacterial superinfection, central nervous system complications, and hospitalization. Stage 2 of this Phase 3 open-label study (ClinicalTrials.gov identifier: NCT03843632) enrolled 100 healthy infants, children, and adolescents (12 months-6 years, n = 37; 7-12 years, n = 33; 13-17 years, n = 30) without a clinical history of varicella. Participants aged 12 months-12 years were administered 1 dose of VARIVAX™ 0.5 mL (Varicella Virus Vaccine Live [Oka/Merck]) and adolescents aged 13-17 years were administered 2 doses 6 weeks apart. For participants seronegative at baseline (VZV antibody titer <1.25 glycoprotein enzyme-linked immunosorbent assay [gpELISA] units/mL), immunogenicity was assessed by seroconversion (VZV antibody titer ≥5 gpELISA units/mL) and VZV antibody geometric mean titers 6 weeks after the final dose. For participants who were VZV seropositive at baseline (VZV antibody titer ≥1.25 gpELISA units/mL), immunogenicity was assessed by antibody titer geometric mean fold rise and percentage of participants with ≥4-fold rise in antibody titer 6 weeks after the final dose. A Vaccine Report Card was used to report solicited and unsolicited adverse events through 42 days post-vaccination. After series completion among seronegative participants across age groups (n = 74), 98.6% demonstrated seroconversion 6 weeks post-vaccination; among seropositive participants (n = 26), 65.4% had ≥4-fold rise in antibody titer 6 weeks post-vaccination. No new safety signals were observed. Administering VARIVAX to infants, children, and adolescents resulted in an acceptable immune response with a safety profile consistent with the licensed product.

2021-05-01·Vaccine3区 · 医学

Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries

3区 · 医学

Article

作者: Pazdiora, Petr ; Stefkovicova, Maria ; Ruzkova, Renata ; Man, Sorin ; Prymula, Roman ; Czajka, Hanna ; Wysocki, Jacek ; Usonis, Vytautas ; Leviniene, Giedra ; Habib, Md Ahsan ; Povey, Michael ; Brzostek, Jerzy ; Neamtu, Mihai ; Casabona, Giacomo ; Chlibek, Roman ; Plesca, Doina ; Cabrnochova, Hana ; Verdanova, Daniela

BACKGROUNDWe assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia.METHODSThis was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded.RESULTSA total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified.CONCLUSIONSOur results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.

100 项与 Varicella Virus Vaccine(Novartis Vaccines) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流行性脑脊髓膜炎	临床2期	加拿大	Novartis Vaccines & Diagnostics, Inc.	2005-06-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00310856 (CTgov)	临床2期	流行性脑脊髓膜炎	175	Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_6-12 M)	顧襯鑰鹽願觸觸範築遞(簾範襯廠憲鹽鹹鏇齋窪) = 製餘襯廠壓範範鹹夢願獵壓膚簾觸鹹襯廠醖餘 (鑰糧衊鏇糧鏇積廠範窪, 繭選遞積鹽構憲遞繭願 ~ 蓋壓壓顧遞憲遞願構餘) 更多	-	2013-11-01
				Varicella+MMR+DTaP-Hib-IPV+MenACWY-CRM+PC7 (MenACWY-CRM_12 M)	顧襯鑰鹽願觸觸範築遞(簾範襯廠憲鹽鹹鏇齋窪) = 醖鹹鑰鏇襯構襯廠遞鑰獵壓膚簾觸鹹襯廠醖餘 (鑰糧衊鏇糧鏇積廠範窪, 鑰範觸艱襯鏇衊構積廠 ~ 鑰鏇襯蓋網襯窪選膚醖) 更多
NCT00806195 (CTgov)	临床3期	脑膜炎 \| 脑膜炎球菌感染	7,744	Hepatitis A Virus+Varicella Vaccine+DTaP (Diptheria, Tetanus, Pertussis) Vaccine+MenACWY-CRM197 (MenACWY-CRM197 + Routine Vaccines (Detailed))	鹹廠鹹壓衊窪鏇築壓觸(積獵膚選夢積鏇願鬱壓) = 觸壓淵淵齋淵糧鹽襯衊鏇觸膚鏇範壓網夢願壓 (製築積鏇夢艱夢窪積範, 顧遞選積願夢顧鑰鏇鹽 ~ 顧艱簾鏇獵夢鹹鹽構網) 更多	-	2013-07-09
				Hepatitis A Virus+Varicella Vaccine+DTaP (Diptheria, Tetanus, Pertussis) Vaccine (Routine Vaccines (Detailed))	鹹廠鹹壓衊窪鏇築壓觸(積獵膚選夢積鏇願鬱壓) = 鑰鹹鏇夢鏇簾衊廠蓋鬱鏇觸膚鏇範壓網夢願壓 (製築積鏇夢艱夢窪積範, 淵鏇衊選憲艱窪遞選選 ~ 壓觸簾願蓋鏇鏇鏇簾遞) 更多